A Study to Evaluate Safety and Efficacy of PF-06826647 Fo... | NCT03895372 | Trialant
NCT03895372
Sponsor
Pfizer
Status
Completed
Last Update Posted
Aug 27, 2021Actual
Enrollment
179Actual
Phase
Phase 2
Conditions
Psoriasis
Interventions
PF-06826647 or Placebo
PF-06826647
Countries
United States
Canada
Japan
Poland
Protocol Section
Identification Module
NCT ID
NCT03895372
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C2501004
Secondary IDs
ID
Type
Description
Link
2018-004669-16
EudraCT Number
Brief Title
A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis
Official Title
A PHASE 2, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Aug 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 27, 2019Actual
Primary Completion Date
May 21, 2020Actual
Completion Date
Nov 26, 2020Actual
First Submitted Date
Mar 13, 2019
First Submission Date that Met QC Criteria
Mar 27, 2019
First Posted Date
Mar 29, 2019Actual
Results Waived
Not provided
Results First Submitted Date
May 3, 2021
Results First Submitted that Met QC Criteria
Aug 25, 2021
Results First Posted Date
Aug 27, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 25, 2021
Last Update Posted Date
Aug 27, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This multicenter study is being conducted to provide additional PF-06826647 safety and tolerability data, and to further explore the clinical efficacy of PF-06826647 in the treatment of moderate to severe plaque psoriasis. Additionally, the study is intended to enable selection of oral dose and dosing regimen for the future clinical development of PF-06826647.
Detailed Description
Not provided
Conditions Module
Conditions
Psoriasis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
179Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PF-06826647 Drug Dose Level 1
Experimental
Delivered orally for 16 weeks during the Investigational Treatment Period
Drug: PF-06826647 or Placebo
PF-06826647 Placebo
Experimental
Delivered orally for 16 weeks during the Investigational Treatment Period
Drug: PF-06826647 or Placebo
PF-06826647 Drug Dose Level 2
Experimental
Delivered orally for 16 weeks during the Investigational Treatment Period
Drug: PF-06826647 or Placebo
PF-06826647 Drug Dose Level 3
Experimental
Delivered orally for 16 weeks during the Investigational Treatment Period then 24 weeks in Extension Period.
Drug: PF-06826647 or Placebo
Drug: PF-06826647
PF-06826647 Drug Dose Level 4
Experimental
Delivered orally for 16 weeks then for 24 weeks in Extension Period.
Drug: PF-06826647 or Placebo
Drug: PF-06826647
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-06826647 or Placebo
Drug
Delivered orally (tablet) once daily (QD) for 16 weeks during the Investigational Treatment Period
PF-06826647 Drug Dose Level 1
PF-06826647 Drug Dose Level 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. The statistical analysis was for the data at Week 16.
Baseline up to Week 16
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time.
From Week 16 to Week 40
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. Relatedness to investigational product (PF-06826647 or placebo) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. The statistical analysis was for the data at Week 16.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female between the ages of 18 and 75 years.
Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months.
Have a PASI score of 12 or greater AND a Physician Global Assessment score of 3 (moderate) or 4 (severe).
Have plaque-type psoriasis covering at least 10 % of total body surface area (BSA).
Exclusion Criteria:
Have non-plaque forms of psoriasis.
Drug-induced psoriasis.
Current active infection.
Infected with Mycobacterium tuberculosis (TB).
Have any history of malignancies.
Require treatment with prohibited concomitant medications(s).
Positive for hepatitis B or C, or human immunodeficiency virus (HIV).
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Alliance Dermatology and Mohs Center
Phoenix
Arizona
85032
United States
Center for Dermatology and Plastic Surgery/CCT
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
This was a Phase 2b, randomized, double blind, placebo controlled, parallel group, and multicenter study in participants with moderate to severe plaque psoriasis.
Recruitment Details
This study included 2 treatment periods (16-week investigational treatment period and 24-week extension treatment period) followed by a 4-week follow-up. A total of 179 participants were enrolled and 178 participants were treated in investigational treatment period and 153 participants completed this period and entered the extension treatment period. A total of 130 participants completed the extension treatment period.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
Periods
Title
Milestones
Reasons Not Completed
Investigational Treatment Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 1, 2019
May 3, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
PF-06826647 Drug Dose Level 3
PF-06826647 Drug Dose Level 4
PF-06826647 Placebo
PF-06826647
Drug
Delivered orally (tablet) once daily (QD) for 24 weeks during the Extension Period
PF-06826647 Drug Dose Level 3
PF-06826647 Drug Dose Level 4
From Week 16 to Week 40
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Following hematology parameters were analyzed for laboratory examination: hemoglobin (HGB), hematocrit, erythrocytes (Ery.), reticulocytes, Ery. mean corpuscular volume, Ery. mean corpuscular HGB, Ery. mean corpuscular HGB concentration, platelets, reticulocytes/erythrocytes, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, activated partial thromboplastin time, prothrombin time, prothrombin international (Intl.) normalized ratio, neutrophils total count, and lymphocytes total count. LLN=lower limit of normal; ULN=upper limit of normal.
From Week 16 to Week 40
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Following clinical chemistry parameters were analyzed for laboratory examination: bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, and cholesterol.
From Week 16 to Week 40
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Following urinalysis parameters were analyzed for laboratory examination: urine pH, urine glucose, urine ketones, urine protein, urine hemoglobin, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline, and urine bacteria.
From Week 16 to Week 40
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
Criteria for ECG abnormalities: maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 milliseconds (msec) and Pctchg>=50% for baseline value of <=200 msec for PR interval, a maximum IFB: Pctchg>=50%, maximum QTcF interval (Fridericia's Correction) of 450 msec to <=480 msec, 480 msec to <=500 msec and a maximum change of <30 change =<60 or >60 msec from baseline.
From Week 16 to Week 40
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
The vital signs were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Criteria for vital signs abnormalities: sitting diastolic blood pressure (BP) < 50 millimeter of mercury (mmHg), sitting diastolic BP change >= 20 mmHg increase, sitting diastolic BP change >= 20 mmHg decrease, sitting systolic BP < 90 mmHg, sitting systolic BP change >= 30 mmHg increase, and sitting systolic BP change >= 30 mmHg decrease.
From Week 16 to Week 40
Baseline up to Week 16
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). The statistical analysis was for the data at Week 16.
Baseline up to Week 16
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). The statistical analysis was for the data at Week 16.
Baseline up to Week 16
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline.
Baseline up to Week 16
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 100 response was defined as at least a 100 percent (%) reduction in PASI relative to Baseline.
Baseline up to Week 16
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. The statistical analysis was for the data at Week 16.
Baseline up to Week 16
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. The statistical analysis was for the data at Week 16.
Baseline up to Week 16
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
The intensity of pruritus was assessed by a PP-NRS, an 11-category numeric rating scale from 0 to 10, which was participant reported. Participants were asked to assess their itch over the past 24 hours, anchored by the terms "no itch" (0) and "worst itch imaginable" (10) at the ends. The statistical analysis was for the data at Week 16.
Baseline up to Week 16
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
The Psoriasis Symptom Inventory (PSI) is a self administered 8-item questionnaire that measures the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure includes concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Participants were asked to respond to each item using a 5-point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. The statistical analysis was for the data at Week 16.
Baseline up to Week 16
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
The Psoriasis Symptom Inventory (PSI) is a self administered 8-item questionnaire that measures the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure includes concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Participants were asked to respond to each item using a 5-point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. The outcome of PSI is the sum of the scores for the 8 items. The total score range of PSI is 0-32. A negative change from baseline means a better outcome and the bigger score decrease means a better outcome. The statistical analysis was for the data at Week 16.
Baseline up to Week 16
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time.
Baseline up to Week 16
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug ((PF-06826647 or placebo). Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. Relatedness to investigational product (PF-06826647 or placebo) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Baseline up to Week 16
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
Criteria for ECG abnormalities: Criteria for ECG abnormalities: maximum PR interval >=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 msec and Pctchg>=50% for baseline value of <=200 msec for PR interval, maximum QRS interval >=140 msec and a maximum IFB: Pctchg>=50%, maximum QTcF interval (Fridericia's Correction) of 450 msec to <=480 msec, 480 msec to <=500 msec and a maximum change of <30change<=60 or >60 msec from baseline.
Baseline up to Week 16
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
The vital signs were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Criteria for vital signs abnormalities: pulse rate >120 beats per minute (BPM), sitting diastolic blood pressure (BP) change >=20 millimeter of mercury (mmHg) increase, sitting diastolic BP change >=20 mmHg decrease, sitting systolic BP <90 mmHg, sitting systolic BP change >=30 mmHg increase, and sitting systolic BP change >=30 mmHg decrease.
Baseline up to Week 16
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Following hematology parameters were analyzed for laboratory examination: hemoglobin (HGB), hematocrit, erythrocytes (Ery.), reticulocytes, Ery. mean corpuscular volume, Ery. mean corpuscular HGB, Ery. mean corpuscular HGB concentration, platelets, reticulocytes/erythrocytes, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, activated partial thromboplastin time, prothrombin time, neutrophils total count, and lymphocytes total count. LLN=lower limit of normal; ULN=upper limit of normal.
Baseline up to Week 16
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Following clinical chemistry parameters were analyzed for laboratory examination: bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, high-density lipoprotein (HDL) cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, and cholesterol. LLN=lower limit of normal; ULN=upper limit of normal.
Baseline up to Week 16.
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Following urinalysis parameters were analyzed for laboratory examination: urine pH, urine glucose, urine ketones, urine protein, urine hemoglobin, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline, and urine bacteria.
Baseline up to Week 16
Scottsdale
Arizona
85260
United States
Center for Dermatology and Plastic Surgery
Scottsdale
Arizona
85260
United States
Anaheim Clinical Trials, LLC
Anaheim
California
92801
United States
Kern Research. Inc.
Bakersfield
California
93301
United States
California Dermatology & Clinical Research Institute
Encinitas
California
92024
United States
Imaging Healthcare Specialists
San Diego
California
92103
United States
Medderm Associates Dermatology
San Diego
California
92103
United States
University Clinical Trials
San Diego
California
92123
United States
Renstar Medical Research
Ocala
Florida
34470
United States
MidState Skin Institute
Ocala
Florida
34471
United States
Renstar Medical Research
Ocala
Florida
34471
United States
Advanced Diagnostic Group
Orange Park
Florida
32073
United States
Park Avenue Dermatology
Orange Park
Florida
32073
United States
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
Ormond Beach
Florida
32174
United States
ForCare Clinical Research
Tampa
Florida
33613
United States
Hamilton Research, LLC
Alpharetta
Georgia
30022
United States
Epiphany Dermatology of Kansas, LLC
Overland Park
Kansas
66215
United States
Qualmedica Research, LLC
Owensboro
Kentucky
42301
United States
Owensboro Dermatology Associates
Owensboro
Kentucky
42303
United States
DelRicht Research
Baton Rouge
Louisiana
70809
United States
DelRicht Research
Baton Rouge
Louisiana
70816
United States
Vital Prospects Clinical Research Institute, PC
Tulsa
Oklahoma
74136
United States
Arlington Research Center, Inc.
Arlington
Texas
76011
United States
Wiseman Dermatology Research Inc.
Winnipeg
Manitoba
R3M 3Z4
Canada
SKiN Health
Cobourg
Ontario
K9A 0Z4
Canada
Dermatrials Research
Hamilton
Ontario
L8N 1Y2
Canada
Lynderm Research Inc.
Markham
Ontario
L3P 1X3
Canada
Toronto Research Centre
Toronto
Ontario
M3H 5Y8
Canada
K. Papp Clinical Research
Waterloo
Ontario
N2J 1C4
Canada
Centre Radiologique de l'Estrie
Sherbrooke
Quebec
J1L 0H8
Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke
Quebec
J1L 0H8
Canada
Nagoya City University Hospital
Nagoya
Aichi-ken
467-8602
Japan
Teikyo University Hospital
Itabashi-ku
Tokyo
173-8606
Japan
NTT Medical Center Tokyo
Shinagawa-ku
Tokyo
141-8625
Japan
Seibo International Catholic Hospital
Shinjuku-ku
Tokyo
161-8521
Japan
Fukuoka University Hospital
Fukuoka
814-0180
Japan
Tokyo Medical University Hospital
Tokyo
160-0023
Japan
Malopolskie Centrum Medyczn
Krakow
Lesser Poland Voivodeship
30-510
Poland
MTZ Clinical Research Sp. z o.o.
Warsaw
Masovian Voivodeship
02-106
Poland
Zdrowie Osteo-Medic s.c. L. i A. Racewicz, A. i J. Supronik
Bialystok
Podlaskie Voivodeship
15-351
Poland
SpecDerm Poznanska Sp. J.
Bialystok
15-375
Poland
Prywatny Gabinet Dermatologiczny Elzbieta Klujszo
Kielce
25-316
Poland
Pratia MCM Krakow
Krakow
30-510
Poland
Tomasz Blicharski Lubelskie Centrum Diagnostyczne
Swidnik, Lubelskie
21-040
Poland
FG001
Placebo QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
FG002
PF-06826647 50 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
FG003
PF-06826647 50 mg QD->PF-06826647 400 mg QD Group
This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
FG004
PF-06826647 100 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
FG005
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
FG006
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
FG007
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
FG00023 subjects
FG00122 subjects
FG00211 subjects
FG00311 subjects
FG00412 subjects
FG00511 subjects
FG00645 subjects
FG00743 subjects
COMPLETED
FG00019 subjects
FG00119 subjects
FG00210 subjects
FG0039 subjects
FG00412 subjects
FG0059 subjects
FG00637 subjects
FG00738 subjects
NOT COMPLETED
FG0004 subjects
FG0013 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
FG0052 subjects
FG0068 subjects
FG0075 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0064 subjects
FG0073 subjects
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0013 subjects
FG0021 subjects
FG0031 subjects
FG004
Extension Treatment Period
Type
Comment
Milestone Data
STARTED
FG00019 subjects
FG00119 subjects
FG00210 subjects
FG0039 subjects
FG00412 subjects
FG0059 subjects
FG00637 subjects
FG00738 subjects
COMPLETED
FG00016 subjects
FG00114 subjects
FG00210 subjects
FG0038 subjects
FG004
NOT COMPLETED
FG0003 subjects
FG0015 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Demographic and baseline characteristics were summarized by randomized treatment group for all randomized and treated participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
BG001
Placebo QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
BG002
PF-06826647 50 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
BG003
PF-06826647 50 mg QD->PF-06826647 400 mg QD Group
This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
BG004
PF-06826647 100 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
BG005
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
BG006
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
BG007
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00023
BG00122
BG00211
BG00311
BG00412
BG00511
BG00645
BG00743
BG008178
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
18-44 Years
Title
Measurements
BG0009
BG00111
BG0027
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0007
BG0018
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0011
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG00020
BG00119
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. The statistical analysis was for the data at Week 16.
The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).
Posted
Number
90% Confidence Interval
Percentage of participants
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
OG001
PF-06826647 50 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
Units
Counts
Participants
OG00042
OG00122
OG00221
OG003
Title
Denominators
Categories
Week 1
Title
Measurements
OG0000(0.00 to 6.41)
OG0010(0.00 to 12.60)
OG0020(0.00 to 12.33)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The analysis was based on the data at Week 16.
Chan and Zhang method
0.2621
One-sided Hochberg p-value, significant level is 0.05.
Risk Difference (RD)
8.87
2-Sided
90
-4.50
26.26
Superiority
OG000
OG002
Primary
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time.
The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who were treated in the extension treatment period.
Posted
Count of Participants
Participants
From Week 16 to Week 40
ID
Title
Description
OG000
Placebo QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
Primary
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. Relatedness to investigational product (PF-06826647 or placebo) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who entered the extension treatment period.
Posted
Count of Participants
Participants
From Week 16 to Week 40
ID
Title
Description
OG000
Placebo QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
Primary
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Following hematology parameters were analyzed for laboratory examination: hemoglobin (HGB), hematocrit, erythrocytes (Ery.), reticulocytes, Ery. mean corpuscular volume, Ery. mean corpuscular HGB, Ery. mean corpuscular HGB concentration, platelets, reticulocytes/erythrocytes, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, activated partial thromboplastin time, prothrombin time, prothrombin international (Intl.) normalized ratio, neutrophils total count, and lymphocytes total count. LLN=lower limit of normal; ULN=upper limit of normal.
The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who were treated in the extension treatment period, with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time from week 16 to week 40.
Posted
Count of Participants
Participants
From Week 16 to Week 40
ID
Title
Description
OG000
Placebo QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
Primary
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Following clinical chemistry parameters were analyzed for laboratory examination: bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, and cholesterol.
The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who were treated in the extension treatment period, with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time from week 16 to week 40.
Posted
Count of Participants
Participants
From Week 16 to Week 40
ID
Title
Description
OG000
Placebo QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
Primary
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Following urinalysis parameters were analyzed for laboratory examination: urine pH, urine glucose, urine ketones, urine protein, urine hemoglobin, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline, and urine bacteria.
The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who were treated in the extension treatment period, with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time from week 16 to week 40.
Posted
Count of Participants
Participants
From Week 16 to Week 40
ID
Title
Description
OG000
Placebo QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
OG001
Primary
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
Criteria for ECG abnormalities: maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 milliseconds (msec) and Pctchg>=50% for baseline value of <=200 msec for PR interval, a maximum IFB: Pctchg>=50%, maximum QTcF interval (Fridericia's Correction) of 450 msec to <=480 msec, 480 msec to <=500 msec and a maximum change of <30 change =<60 or >60 msec from baseline.
The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and were treated in the extension treatment period and evaluated against criteria.
Posted
Count of Participants
Participants
From Week 16 to Week 40
ID
Title
Description
OG000
Placebo QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
Primary
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
The vital signs were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Criteria for vital signs abnormalities: sitting diastolic blood pressure (BP) < 50 millimeter of mercury (mmHg), sitting diastolic BP change >= 20 mmHg increase, sitting diastolic BP change >= 20 mmHg decrease, sitting systolic BP < 90 mmHg, sitting systolic BP change >= 30 mmHg increase, and sitting systolic BP change >= 30 mmHg decrease.
The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who entered the extension treatment period.
Posted
Count of Participants
Participants
From Week 16 to Week 40
ID
Title
Description
OG000
Placebo QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
OG001
Secondary
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. The statistical analysis was for the data at Week 16.
The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).
Posted
Number
90% Confidence Interval
Percentage of participants
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
Secondary
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear" and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). The statistical analysis was for the data at Week 16.
The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).
Posted
Number
90% Confidence Interval
Percentage of participants
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
Secondary
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of "Clear" or "Almost Clear", Up to Week 16 - Investigational Treatment Period
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). The statistical analysis was for the data at Week 16.
The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).
Posted
Number
90% Confidence Interval
Percentage of participants
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
Secondary
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline.
The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who were evaluated against criteria.
Posted
Number
Percentage of participants
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
Secondary
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period
The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 100 response was defined as at least a 100 percent (%) reduction in PASI relative to Baseline.
The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who were evaluated against criteria.
Posted
Number
Percentage of participants
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
Secondary
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. The statistical analysis was for the data at Week 16.
The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who had observed data.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
Secondary
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. The statistical analysis was for the data at Week 16.
The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who had observed data.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
Secondary
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
The intensity of pruritus was assessed by a PP-NRS, an 11-category numeric rating scale from 0 to 10, which was participant reported. Participants were asked to assess their itch over the past 24 hours, anchored by the terms "no itch" (0) and "worst itch imaginable" (10) at the ends. The statistical analysis was for the data at Week 16.
The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who had observed data.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
OG001
PF-06826647 50 mg QD Group
Secondary
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of "Not at All" or "Mild" on Every Item, Up to Week 16 - Investigational Treatment Period
The Psoriasis Symptom Inventory (PSI) is a self administered 8-item questionnaire that measures the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure includes concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Participants were asked to respond to each item using a 5-point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. The statistical analysis was for the data at Week 16.
The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).
Posted
Number
90% Confidence Interval
Percentage of participants
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
Secondary
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
The Psoriasis Symptom Inventory (PSI) is a self administered 8-item questionnaire that measures the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure includes concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Participants were asked to respond to each item using a 5-point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. The outcome of PSI is the sum of the scores for the 8 items. The total score range of PSI is 0-32. A negative change from baseline means a better outcome and the bigger score decrease means a better outcome. The statistical analysis was for the data at Week 16.
The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who had observed data.
Posted
Least Squares Mean
Standard Error
Unit on a scale
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
Secondary
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time.
The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo).
Posted
Count of Participants
Participants
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
OG001
Secondary
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug ((PF-06826647 or placebo). Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. Relatedness to investigational product (PF-06826647 or placebo) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo).
Posted
Count of Participants
Participants
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
Secondary
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
Criteria for ECG abnormalities: Criteria for ECG abnormalities: maximum PR interval >=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 msec and Pctchg>=50% for baseline value of <=200 msec for PR interval, maximum QRS interval >=140 msec and a maximum IFB: Pctchg>=50%, maximum QTcF interval (Fridericia's Correction) of 450 msec to <=480 msec, 480 msec to <=500 msec and a maximum change of <30change<=60 or >60 msec from baseline.
The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who had at least 1 ECG assessment.
Posted
Count of Participants
Participants
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
OG001
PF-06826647 50 mg QD Group
Secondary
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
The vital signs were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Criteria for vital signs abnormalities: pulse rate >120 beats per minute (BPM), sitting diastolic blood pressure (BP) change >=20 millimeter of mercury (mmHg) increase, sitting diastolic BP change >=20 mmHg decrease, sitting systolic BP <90 mmHg, sitting systolic BP change >=30 mmHg increase, and sitting systolic BP change >=30 mmHg decrease.
The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and were evaluated against the criteria.
Posted
Count of Participants
Participants
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
OG001
PF-06826647 50 mg QD Group
Secondary
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Following hematology parameters were analyzed for laboratory examination: hemoglobin (HGB), hematocrit, erythrocytes (Ery.), reticulocytes, Ery. mean corpuscular volume, Ery. mean corpuscular HGB, Ery. mean corpuscular HGB concentration, platelets, reticulocytes/erythrocytes, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, activated partial thromboplastin time, prothrombin time, neutrophils total count, and lymphocytes total count. LLN=lower limit of normal; ULN=upper limit of normal.
The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo), with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time up to week 16.
Posted
Count of Participants
Participants
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
Secondary
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Following clinical chemistry parameters were analyzed for laboratory examination: bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, high-density lipoprotein (HDL) cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, and cholesterol. LLN=lower limit of normal; ULN=upper limit of normal.
The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo), with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time up to week 16.
Posted
Count of Participants
Participants
Baseline up to Week 16.
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
OG001
Secondary
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Following urinalysis parameters were analyzed for laboratory examination: urine pH, urine glucose, urine ketones, urine protein, urine hemoglobin, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline, and urine bacteria.
The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo), with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time up to week 16.
Posted
Count of Participants
Participants
Baseline up to Week 16
ID
Title
Description
OG000
Placebo QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 116 days in investigational treatment period.
OG001
PF-06826647 50 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Time Frame
From the first dose of study treatment on Day 1 to 28 calendar days after the last dose of study treatment on Day 280
Description
Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate. In Section Outcome Measures, there were 2 separate summary data for the 2 periods is because the investigational treatment period contains the data for the primary endpoint.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period.
0
23
0
23
14
23
EG001
Placebo QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
0
22
1
22
11
22
EG002
PF-06826647 50 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
0
11
0
11
10
11
EG003
PF-06826647 50 mg QD->PF-06826647 400 mg QD Group
This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
0
11
1
11
8
11
EG004
PF-06826647 100 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
0
12
0
12
9
12
EG005
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
0
11
1
11
9
11
EG006
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
0
45
3
45
29
45
EG007
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
0
43
0
43
32
43
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hypoacusis
Ear and labyrinth disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG0031 affected11 at risk
EG0040 affected12 at risk
EG0050 affected11 at risk
EG0060 affected45 at risk
EG0070 affected43 at risk
Chest pain
General disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Viral sepsis
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Fibrin D dimer increased
Investigations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Presyncope
Nervous system disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Hypertension
Vascular disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0011 affected22 at risk
EG0020 affected11 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG0032 affected11 at risk
EG0040 affected12 at risk
EG0050 affected11 at risk
EG0061 affected45 at risk
EG0073 affected43 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0021 affected11 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA v23.1
Non-systematic Assessment
EG0002 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Lymphocytosis
Blood and lymphatic system disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v23.1
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected22 at risk
EG0021 affected11 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v23.1
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0021 affected11 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v23.1
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Vestibular disorder
Ear and labyrinth disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Autoimmune thyroiditis
Endocrine disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Diplopia
Eye disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Strabismus
Eye disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0012 affected22 at risk
EG0020 affected11 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v23.1
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v23.1
Non-systematic Assessment
EG0001 affected23 at risk
EG0011 affected22 at risk
EG0020 affected11 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Asthenia
General disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Fatigue
General disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0011 affected22 at risk
EG0020 affected11 at risk
EG003
Feeling hot
General disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Oedema peripheral
General disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0011 affected22 at risk
EG0021 affected11 at risk
EG003
Peripheral swelling
General disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Pyrexia
General disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Vessel puncture site bruise
General disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Erythema migrans
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Folliculitis
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0002 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0011 affected22 at risk
EG0020 affected11 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Hordeolum
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0021 affected11 at risk
EG003
Laryngitis
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0006 affected23 at risk
EG0011 affected22 at risk
EG0023 affected11 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0011 affected22 at risk
EG0020 affected11 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0001 affected23 at risk
EG0011 affected22 at risk
EG0022 affected11 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0001 affected23 at risk
EG0011 affected22 at risk
EG0021 affected11 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA v23.1
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Diffuse axonal injury
Injury, poisoning and procedural complications
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0011 affected22 at risk
EG0020 affected11 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0021 affected11 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA v23.1
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected22 at risk
EG0021 affected11 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v23.1
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA v23.1
Non-systematic Assessment
EG0001 affected23 at risk
EG0011 affected22 at risk
EG0020 affected11 at risk
EG003
Blood pressure diastolic increased
Investigations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Blood pressure increased
Investigations
MedDRA v23.1
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected22 at risk
EG0021 affected11 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA v23.1
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected22 at risk
EG0021 affected11 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0021 affected11 at risk
EG003
Serum ferritin increased
Investigations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Transaminases increased
Investigations
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v23.1
Non-systematic Assessment
EG0002 affected23 at risk
EG0011 affected22 at risk
EG0020 affected11 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v23.1
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected22 at risk
EG0021 affected11 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Limb discomfort
Musculoskeletal and connective tissue disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Circadian rhythm sleep disorder
Nervous system disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Headache
Nervous system disorders
MedDRA v23.1
Non-systematic Assessment
EG0002 affected23 at risk
EG0011 affected22 at risk
EG0021 affected11 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Sciatica
Nervous system disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0021 affected11 at risk
EG003
Syncope
Nervous system disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0021 affected11 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Depression
Psychiatric disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0021 affected11 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0021 affected11 at risk
EG003
Nasal mucosal hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Nasal polyps
Respiratory, thoracic and mediastinal disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0021 affected11 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0021 affected11 at risk
EG003
Pseudofolliculitis
Skin and subcutaneous tissue disorders
MedDRA v23.1
Non-systematic Assessment
EG0000 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA v23.1
Non-systematic Assessment
EG0001 affected23 at risk
EG0010 affected22 at risk
EG0020 affected11 at risk
EG003
Hypertension
Vascular disorders
MedDRA v23.1
Non-systematic Assessment
EG0001 affected23 at risk
EG0011 affected22 at risk
EG0020 affected11 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
45
OG00441
0
(0.00 to 5.97)
OG0040(0.00 to 6.57)
Week 2
Title
Measurements
OG0000(0.00 to 6.41)
OG0010(0.00 to 12.60)
OG0020(0.00 to 12.33)
OG0032.2(0.23 to 9.17)
OG0040(0.00 to 6.57)
Week 4
Title
Measurements
OG0000(0.00 to 6.41)
OG0010(0.00 to 12.60)
OG0020(0.00 to 12.33)
OG00311.1(5.50 to 21.80)
OG0047.3(2.72 to 17.32)
Week 6
Title
Measurements
OG0000(0.00 to 6.41)
OG0014.5(0.48 to 19.56)
OG0024.8(0.50 to 20.57)
OG00320.0(11.72 to 31.73)
OG00426.8(17.12 to 39.77)
Week 8
Title
Measurements
OG0002.4(0.25 to 9.85)
OG0014.5(0.48 to 19.56)
OG0024.8(0.50 to 20.57)
OG00324.4(15.47 to 35.88)
OG00434.1(23.04 to 46.94)
Week 12
Title
Measurements
OG0002.4(0.25 to 9.85)
OG00113.6(5.12 to 31.13)
OG0029.5(2.56 to 24.50)
OG00337.8(25.96 to 50.95)
OG00448.8(35.14 to 62.56)
Week 16
Title
Measurements
OG0004.8(1.27 to 13.53)
OG00113.6(5.12 to 31.13)
OG0029.5(2.56 to 24.50)
OG00337.8(25.96 to 50.95)
OG00451.2(37.44 to 64.86)
The analysis was based on the data at Week 16.
Chan and Zhang method
0.2621
One-sided Hochberg p-value, significant level is 0.05.
Risk Difference (RD)
4.76
2-Sided
90
-7.07
21.48
Superiority
OG000
OG003
The analysis was based on the data at Week 16.
Chan and Zhang method
0.0004
One-sided Hochberg p-value, significant level is 0.05.
Risk Difference (RD)
33.02
2-Sided
90
18.01
47.11
Superiority
OG000
OG004
The analysis was based on the data at Week 16.
Chan and Zhang method
<0.0001
One-sided Hochberg p-value, significant level is 0.05.
Risk Difference (RD)
46.46
2-Sided
90
30.62
60.56
Superiority
OG001
Placebo QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
OG002
PF-06826647 50 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
OG003
PF-06826647 50 mg QD->PF-06826647 400 mg QD Group
This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
OG004
PF-06826647 100 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
OG005
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
OG006
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
OG007
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
Units
Counts
Participants
OG00019
OG00118
OG00210
OG0039
OG00412
OG0059
OG00637
OG00738
Title
Denominators
Categories
Participants with AEs
Title
Measurements
OG00011
OG0018
OG0027
OG0036
OG0047
OG0057
OG00624
OG00726
Participants with SAEs
Title
Measurements
OG0000
OG0011
OG0020
OG003
Participants with severe AEs
Title
Measurements
OG0002
OG0010
OG0020
OG003
Participants discontinued from study due to AEs
Title
Measurements
OG0000
OG0011
OG0020
OG003
Participants discontinued study drug due to AE and continue study
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with dose reduced or temporary discontinuation due to AEs
Title
Measurements
OG0000
OG0010
OG0021
OG003
OG001
Placebo QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
OG002
PF-06826647 50 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
OG003
PF-06826647 50 mg QD->PF-06826647 400 mg QD Group
This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
OG004
PF-06826647 100 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
OG005
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
OG006
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
OG007
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
Units
Counts
Participants
OG00019
OG00118
OG00210
OG0039
OG00412
OG0059
OG00637
OG00738
Title
Denominators
Categories
Participants with AEs
Title
Measurements
OG0004
OG0013
OG0022
OG0033
OG0040
OG0051
OG00610
OG0075
Participants with SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with severe AEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants discontinued from study due to AEs
Title
Measurements
OG0000
OG0011
OG0020
OG003
Participants discontinued study drug due to AE and continue study
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with dose reduced or temporary discontinuation due to AEs
Title
Measurements
OG0000
OG0010
OG0021
OG003
OG001
Placebo QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
OG002
PF-06826647 50 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
OG003
PF-06826647 50 mg QD->PF-06826647 400 mg QD Group
This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
OG004
PF-06826647 100 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
OG005
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
OG006
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
OG007
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
Units
Counts
Participants
OG00019
OG00118
OG00210
OG0039
OG00412
OG0059
OG00637
OG00738
Title
Denominators
Categories
HGB (g/dL) <0.8*LLN
ParticipantsOG00019
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG0039
ParticipantsOG00412
ParticipantsOG0059
ParticipantsOG00637
ParticipantsOG00738
Title
Measurements
OG0000
OG0011
OG0020
OG003
Hematocrit (%) <0.8*LLN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Erythrocytes (10^6/mm^3) <0.8*LLN
ParticipantsOG00018
ParticipantsOG00115
ParticipantsOG0027
ParticipantsOG0039
Reticulocytes (10^3/mm^3) <0.5*LLN
ParticipantsOG00019
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG0039
Reticulocytes (10^3/mm^3) >1.5*ULN
ParticipantsOG00019
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG0039
Ery. Mean Corpuscular Volume (um^3) <0.9*LLN
ParticipantsOG00017
ParticipantsOG00115
ParticipantsOG0028
ParticipantsOG0039
Ery. Mean Corpuscular Volume (um^3) >1.1*ULN
ParticipantsOG00017
ParticipantsOG00115
ParticipantsOG0028
ParticipantsOG0039
Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN
ParticipantsOG00018
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG0039
Ery. Mean Corpuscular HGB (pg/cell) >1.1*ULN
ParticipantsOG00018
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG0039
Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG003
Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG003
Platelets (10^3/mm^3) <0.5*LLN
ParticipantsOG00017
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Platelets (10^3/mm^3) >1.75*ULN
ParticipantsOG00017
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Reticulocytes/Erythrocytes (%) <0.5*LLN
ParticipantsOG00019
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG0039
Reticulocytes/Erythrocytes (%) >1.5*ULN
ParticipantsOG00019
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG0039
Leukocytes(10^3/mm^3) <0.6*LLN
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0037
Leukocytes(10^3/mm^3) >1.5*ULN
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0037
Lymphocytes/Leukocytes (%) <0.8*LLN
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0036
Lymphocytes/Leukocytes (%) >1.2*ULN
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0036
Neutrophils/Leukocytes (%) <0.8*LLN
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0036
Neutrophils/Leukocytes (%) >1.2*ULN
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0036
Basophils (10^3/mm^3) >1.2*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Basophils/Leukocytes (%) >1.2*ULN
ParticipantsOG00016
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0038
Eosinophils (10^3/mm^3) >1.2*ULN
ParticipantsOG00019
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG0039
Eosinophils/Leukocytes (%) >1.2*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG0029
ParticipantsOG0039
Monocytes (10^3/mm^3) >1.2*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0038
Monocytes/Leukocytes (%) >1.2*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Activated Partial Thromboplastin Time (sec) >1.1 x ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG003
Prothrombin Time (sec) >1.1*ULN
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG0029
ParticipantsOG0039
Prothrombin Intl. Normalized Ratio >1.1*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Neutrophils total count (10^3/mm^3) <0.8*LLN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0037
Neutrophils total count (10^3/mm^3) >1.2*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0037
Lymphocytes total count (10^3/mm^3) <0.8*LLN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Lymphocytes total count (10^3/mm^3) >1.2*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
OG001
Placebo QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
OG002
PF-06826647 50 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
OG003
PF-06826647 50 mg QD->PF-06826647 400 mg QD Group
This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
OG004
PF-06826647 100 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
OG005
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
OG006
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
OG007
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
Units
Counts
Participants
OG00019
OG00118
OG00210
OG0039
OG00412
OG0059
OG00637
OG00738
Title
Denominators
Categories
Bilirubin (mg/dL) >1.5*ULN
ParticipantsOG00018
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
ParticipantsOG00412
ParticipantsOG0058
ParticipantsOG00635
ParticipantsOG00738
Title
Measurements
OG0000
OG0010
OG0020
OG003
Direct Bilirubin (mg/dL) >1.5*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Indirect Bilirubin (mg/dL) >1.5*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Aspartate Aminotransferase (U/L) > 3.0*ULN
ParticipantsOG00019
ParticipantsOG00117
ParticipantsOG0028
ParticipantsOG0039
Alanine Aminotransferase (U/L) > 3.0*ULN
ParticipantsOG00018
ParticipantsOG00116
ParticipantsOG0027
ParticipantsOG0038
Gamma Glutamyl Transferase (U/L) > 3.0*ULN
ParticipantsOG00017
ParticipantsOG00115
ParticipantsOG0029
ParticipantsOG0039
Alkaline Phosphatase (U/L) > 3.0*ULN
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG0029
ParticipantsOG0038
Protein (g/dL) <0.8*LLN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Protein (g/dL) >1.2*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Albumin (g/dL) <0.8*LLN
ParticipantsOG00018
ParticipantsOG00116
ParticipantsOG0027
ParticipantsOG0039
Albumin (g/dL) >1.2*ULN
ParticipantsOG00018
ParticipantsOG00116
ParticipantsOG0027
ParticipantsOG0039
Blood Urea Nitrogen (mg/dL) >1.3*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Urea (mg/dL) >1.3*ULN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Creatinine (mg/dL) >1.3*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG0029
ParticipantsOG0039
Urate (mg/dL) >1.2*ULN
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG0029
ParticipantsOG0039
HDL Cholesterol (mg/dL) <0.8*LLN
ParticipantsOG00016
ParticipantsOG00115
ParticipantsOG0029
ParticipantsOG0038
LDL Cholesterol (mg/dL) >1.2*ULN
ParticipantsOG00016
ParticipantsOG00114
ParticipantsOG00210
ParticipantsOG0038
Triglycerides (mg/dL) >1.3*ULN
ParticipantsOG00016
ParticipantsOG00115
ParticipantsOG0028
ParticipantsOG0038
Sodium (Meq/L) <0.95*LLN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Sodium (Meq/L) >1.05*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Potassium (Meq/L) <0.9*LLN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG0029
ParticipantsOG0039
Potassium (Meq/L) >1.1*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG0029
ParticipantsOG0039
Chloride (Meq/L) <0.9*LLN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Chloride (Meq/L) >1.1*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Calcium (mg/dL) <0.9*LLN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Calcium (mg/dL) >1.1*ULN
ParticipantsOG00019
ParticipantsOG00118
ParticipantsOG00210
ParticipantsOG0039
Bicarbonate (Meq/L) <0.9*LLN
ParticipantsOG00019
ParticipantsOG00117
ParticipantsOG0029
ParticipantsOG0039
Bicarbonate (Meq/L) >1.1*ULN
ParticipantsOG00019
ParticipantsOG00117
ParticipantsOG0029
ParticipantsOG0039
Glucose (mg/dL) <0.6*LLN
ParticipantsOG00010
ParticipantsOG00113
ParticipantsOG0027
ParticipantsOG0036
Glucose (mg/dL) >1.5*ULN
ParticipantsOG00010
ParticipantsOG00113
ParticipantsOG0027
ParticipantsOG0036
Creatine Kinase (U/L) >2.0*ULN
ParticipantsOG00017
ParticipantsOG00118
ParticipantsOG0029
ParticipantsOG0039
Cholesterol (mg/dL) >1.3*ULN
ParticipantsOG00015
ParticipantsOG00114
ParticipantsOG0029
ParticipantsOG0037
Placebo QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
OG002
PF-06826647 50 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
OG003
PF-06826647 50 mg QD->PF-06826647 400 mg QD Group
This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
OG004
PF-06826647 100 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
OG005
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
OG006
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
OG007
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
Units
Counts
Participants
OG00019
OG00118
OG00210
OG0039
OG00412
OG0059
OG00637
OG00738
Title
Denominators
Categories
Urine pH (Scalar) <4.5
ParticipantsOG00016
ParticipantsOG00113
ParticipantsOG00210
ParticipantsOG0038
ParticipantsOG0049
ParticipantsOG0058
ParticipantsOG00633
ParticipantsOG00732
Title
Measurements
OG0000
OG0010
OG0020
OG003
Urine pH (Scalar) >8
ParticipantsOG00016
ParticipantsOG00113
ParticipantsOG00210
ParticipantsOG0038
Urine Glucose >=1
ParticipantsOG00015
ParticipantsOG00112
ParticipantsOG0029
ParticipantsOG0038
Urine Ketones (Scalar) >=1
ParticipantsOG00016
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG0038
Urine Protein >=1
ParticipantsOG00016
ParticipantsOG00113
ParticipantsOG00210
ParticipantsOG0038
Urine Hemoglobin (Scalar) >=1
ParticipantsOG00016
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG0038
Urine Urobilinogen (EU/dL) >=1
ParticipantsOG00016
ParticipantsOG00113
ParticipantsOG00210
ParticipantsOG0038
Urine Bilirubin (Scalar) >=1
ParticipantsOG00016
ParticipantsOG00113
ParticipantsOG00210
ParticipantsOG0038
Urine Nitrite (Scalar) >=1
ParticipantsOG00016
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG0038
Urine Leukocyte Esterase (Scalar) >=1
ParticipantsOG00015
ParticipantsOG00112
ParticipantsOG00210
ParticipantsOG0037
Urine Erythrocytes (Scalar) >=20
ParticipantsOG0004
ParticipantsOG0015
ParticipantsOG0022
ParticipantsOG0032
Urine Leukocytes (/HPF) >=20
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0022
ParticipantsOG0031
Urine Hyaline Casts (/LPF) >1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Urine Bacteria (/LPF) >20
ParticipantsOG0003
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
OG001
Placebo QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
OG002
PF-06826647 50 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
OG003
PF-06826647 50 mg QD->PF-06826647 400 mg QD Group
This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
OG004
PF-06826647 100 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
OG005
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
OG006
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
OG007
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
Units
Counts
Participants
OG00017
OG00117
OG00210
OG0039
OG00411
OG0058
OG00637
OG00736
Title
Denominators
Categories
PR interval, single beat (msec) Pctchg >=25/50%
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG0057
ParticipantsOG00637
ParticipantsOG00736
Title
Measurements
OG0000
OG0010
OG0020
OG003
QRS duration, singe beat (msec) Pctchg >=50%
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG0039
QT interval, single beat (msec) >500
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG0039
450< QTcF - Fridericia's correction formula (msec) <=480
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG003
480< QTcF - Fridericia's correction formula (msec) <=500
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG003
30< QTcF - Fridericia's correction formula (msec) change <=60
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG003
QTcF - Fridericia's correction formula (msec) change >60
ParticipantsOG00017
ParticipantsOG00117
ParticipantsOG00210
ParticipantsOG003
Placebo QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2*25 mg size placebo and 4*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period.
OG002
PF-06826647 50 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period.
OG003
PF-06826647 50 mg QD->PF-06826647 400 mg QD Group
This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period.
OG004
PF-06826647 100 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period.
OG005
PF-06826647 100 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period.
OG006
PF-06826647 200 mg QD->PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period.
OG007
PF-06826647 400 mg QD->PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period.
Units
Counts
Participants
OG00019
OG00118
OG00210
OG0039
OG00412
OG0059
OG00637
OG00738
Title
Denominators
Categories
Sitting diastolic BP (mmHg) <50
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Sitting diastolic BP (mmHg) change >= 20 increase
Title
Measurements
OG0000
OG0011
OG0021
OG003
Sitting diastolic BP (mmHg) change >= 20 decrease
Title
Measurements
OG0001
OG0011
OG0020
OG003
Sitting systolic BP (mmHg) <90
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sitting systolic BP (mmHg) change >= 30 increase
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sitting systolic BP (mmHg) change >= 30 decrease
Title
Measurements
OG0000
OG0012
OG0020
OG003
OG001
PF-06826647 50 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Units
Counts
Participants
OG00042
OG00122
OG00221
OG00345
OG00441
Title
Denominators
Categories
Week 1
Title
Measurements
OG0000(0.00 to 6.41)
OG0010(0.00 to 12.60)
OG0020(0.00 to 12.33)
OG0032.2(0.23 to 9.17)
OG0040(0.00 to 6.57)
Week 2
Title
Measurements
OG0004.8(1.27 to 13.53)
OG0010(0.00 to 12.60)
OG0020(0.00 to 12.33)
OG003
Week 4
Title
Measurements
OG0007.1(2.56 to 17.39)
OG0014.5(0.48 to 19.56)
OG0020(0.00 to 12.33)
OG003
Week 6
Title
Measurements
OG0007.1(2.56 to 17.39)
OG00113.6(5.12 to 31.13)
OG0024.8(0.50 to 20.57)
OG003
Week 8
Title
Measurements
OG0004.8(1.27 to 15.53)
OG00113.6(5.12 to 31.13)
OG00214.3(5.37 to 32.81)
OG003
Week 12
Title
Measurements
OG0009.5(4.22 to 19.38)
OG00113.6(5.12 to 31.13)
OG0029.5(2.56 to 24.50)
OG003
Week 16
Title
Measurements
OG00014.3(6.41 to 25.56)
OG00118.2(8.17 to 35.25)
OG0029.5(2.56 to 24.50)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The analysis was based on the data at Week 16.
Risk Difference (RD)
3.90
2-Sided
90
-11.82
23.42
Superiority
OG000
OG002
The analysis was based on the data at Week 16.
Risk Difference (RD)
-4.76
2-Sided
90
-18.61
13.29
Superiority
OG000
OG003
The analysis was based on the data at Week 16.
Risk Difference (RD)
32.38
2-Sided
90
14.32
47.52
Superiority
OG000
OG004
The analysis was based on the data at Week 16.
Risk Difference (RD)
58.89
2-Sided
90
41.01
72.41
Superiority
OG001
PF-06826647 50 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Units
Counts
Participants
OG00042
OG00122
OG00221
OG00345
OG00441
Title
Denominators
Categories
Week 1
Title
Measurements
OG0002.4(0.25 to 9.85)
OG0010(0.00 to 12.60)
OG0024.8(0.50 to 20.57)
OG0034.4(1.19 to 12.58)
OG0044.9(1.30 to 13.87)
Week 2
Title
Measurements
OG0002.4(0.25 to 9.85)
OG0010(0.00 to 12.60)
OG0024.8(0.50 to 20.57)
OG003
Week 4
Title
Measurements
OG0009.5(4.22 to 19.38)
OG0019.1(2.44 to 23.60)
OG0024.8(0.50 to 20.57)
OG003
Week 6
Title
Measurements
OG00014.3(6.41 to 25.56)
OG00113.6(5.12 to 31.13)
OG00214.3(5.37 to 32.81)
OG003
Week 8
Title
Measurements
OG00014.3(6.41 to 25.56)
OG00118.2(8.17 to 35.25)
OG00214.3(5.37 to 32.81)
OG003
Week 12
Title
Measurements
OG00014.3(6.41 to 25.56)
OG00118.2(8.17 to 35.25)
OG00219.0(8.58 to 37.19)
OG003
Week 16
Title
Measurements
OG00016.7(9.06 to 27.68)
OG00118.2(8.17 to 35.25)
OG00214.3(5.37 to 32.81)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The analysis was based on the data at Week 16.
Risk Difference (RD)
1.52
2-Sided
90
-14.52
20.77
Superiority
OG000
OG002
The analysis was based on the data at Week 16.
Risk Difference (RD)
-2.38
2-Sided
90
-17.67
17.01
Superiority
OG000
OG003
The analysis was based on the data at Week 16.
Risk Difference (RD)
27.78
2-Sided
90
8.86
43.26
Superiority
OG000
OG004
The analysis was based on the data at Week 16.
Risk Difference (RD)
54.07
2-Sided
90
36.46
68.27
Superiority
OG001
PF-06826647 50 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Units
Counts
Participants
OG00042
OG00122
OG00221
OG00345
OG00441
Title
Denominators
Categories
Week 1
Title
Measurements
OG0002.4(0.25 to 9.85)
OG0010(0.00 to 12.60)
OG0024.8(0.50 to 20.57)
OG0034.4(1.19 to 12.58)
OG0044.9(1.30 to 13.87)
Week 2
Title
Measurements
OG0002.4(0.25 to 9.85)
OG0010(0.00 to 12.60)
OG0024.8(0.50 to 20.57)
OG003
Week 4
Title
Measurements
OG0009.5(4.22 to 19.38)
OG0019.1(2.44 to 23.60)
OG0024.8(0.50 to 20.57)
OG003
Week 6
Title
Measurements
OG00014.3(6.41 to 25.56)
OG00113.6(5.12 to 31.13)
OG00214.3(5.37 to 32.81)
OG003
Week 8
Title
Measurements
OG00014.3(6.41 to 25.56)
OG00118.2(8.17 to 35.25)
OG00214.3(5.37 to 32.81)
OG003
Week 12
Title
Measurements
OG00014.3(6.41 to 25.56)
OG00118.2(8.17 to 35.25)
OG00219.0(8.58 to 37.19)
OG003
Week 16
Title
Measurements
OG00016.7(9.06 to 27.68)
OG00118.2(8.17 to 35.25)
OG00214.3(5.37 to 32.81)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The analysis was based on the data at Week 16.
Risk Difference (RD)
1.52
2-Sided
90
-14.52
20.77
Superiority
OG000
OG002
The analysis was based on the data at Week 16.
Risk Difference (RD)
-2.38
2-Sided
90
-17.67
17.01
Superiority
OG000
OG003
The analysis was based on the data at Week 16.
Risk Difference (RD)
27.78
2-Sided
90
8.86
43.26
Superiority
OG000
OG004
The analysis was based on the data at Week 16.
Risk Difference (RD)
54.07
2-Sided
90
36.46
68.27
Superiority
OG001
PF-06826647 50 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Units
Counts
Participants
OG00042
OG00122
OG00221
OG00345
OG00441
Title
Denominators
Categories
Week 1
ParticipantsOG00042
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG00344
ParticipantsOG00440
Title
Measurements
OG0002.4
OG0010
OG0024.8
OG003
Week 2
ParticipantsOG00042
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG00345
Week 4
ParticipantsOG00040
ParticipantsOG00121
ParticipantsOG00221
ParticipantsOG00344
Week 6
ParticipantsOG00038
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG00344
Week 8
ParticipantsOG00037
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00341
Week 12
ParticipantsOG00036
ParticipantsOG00120
ParticipantsOG00221
ParticipantsOG00341
Week 16
ParticipantsOG00036
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00338
OG001
PF-06826647 50 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Units
Counts
Participants
OG00042
OG00122
OG00221
OG00345
OG00441
Title
Denominators
Categories
Week 1
ParticipantsOG00042
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG00344
ParticipantsOG00440
Title
Measurements
OG0000
OG0010
OG0020
OG003
Week 2
ParticipantsOG00042
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG00345
Week 4
ParticipantsOG00040
ParticipantsOG00121
ParticipantsOG00221
ParticipantsOG00344
Week 6
ParticipantsOG00038
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG00344
Week 8
ParticipantsOG00037
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00341
Week 12
ParticipantsOG00036
ParticipantsOG00120
ParticipantsOG00221
ParticipantsOG00341
Week 16
ParticipantsOG00036
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00338
OG001
PF-06826647 50 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Units
Counts
Participants
OG00042
OG00122
OG00221
OG00345
OG00441
Title
Denominators
Categories
Week 1
ParticipantsOG00042
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG00344
ParticipantsOG00440
Title
Measurements
OG000-1.88± 0.697
OG001-2.82± 0.969
OG002-1.96± 0.984
OG003
Week 2
ParticipantsOG00042
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG00345
Week 4
ParticipantsOG00040
ParticipantsOG00121
ParticipantsOG00221
ParticipantsOG00344
Week 6
ParticipantsOG00038
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG00344
Week 8
ParticipantsOG00037
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00341
Week 12
ParticipantsOG00036
ParticipantsOG00120
ParticipantsOG00221
ParticipantsOG00341
Week 16
ParticipantsOG00036
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00338
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The analysis was based on the data at Week 16.
Least Squares Mean Difference
-1.46
2-Sided
90
-5.42
2.51
Superiority
OG000
OG002
The analysis was based on the data at Week 16.
Least Squares Mean Difference
-3.54
2-Sided
90
-7.50
0.42
Superiority
OG000
OG003
The analysis was based on the data at Week 16.
Least Squares Mean Difference
-9.80
2-Sided
90
-13.05
-6.56
Superiority
OG000
OG004
The analysis was based on the data at Week 16.
Least Squares Mean Difference
-12.33
2-Sided
90
-15.61
-9.04
Superiority
OG001
PF-06826647 50 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Units
Counts
Participants
OG00042
OG00122
OG00221
OG00345
OG00441
Title
Denominators
Categories
Week 1
ParticipantsOG00042
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG00344
ParticipantsOG00440
Title
Measurements
OG000-5.63± 2.858
OG001-9.42± 3.975
OG002-8.93± 4.039
OG003
Week 2
ParticipantsOG00042
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG00345
Week 4
ParticipantsOG00040
ParticipantsOG00121
ParticipantsOG00221
ParticipantsOG00344
Week 6
ParticipantsOG00038
ParticipantsOG00121
ParticipantsOG00220
ParticipantsOG00344
Week 8
ParticipantsOG00037
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00341
Week 12
ParticipantsOG00036
ParticipantsOG00120
ParticipantsOG00221
ParticipantsOG00341
Week 16
ParticipantsOG00036
ParticipantsOG00120
ParticipantsOG00220
ParticipantsOG00338
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The analysis was based on the data at Week 16.
Least Squares Mean Difference
-8.63
2-Sided
90
-23.61
6.35
Superiority
OG000
OG002
The analysis was based on the data at Week 16.
Least Squares Mean Difference
-13.02
2-Sided
90
-27.98
1.94
Superiority
OG000
OG003
The analysis was based on the data at Week 16.
Least Squares Mean Difference
-40.74
2-Sided
90
-53.02
-28.46
Superiority
OG000
OG004
The analysis was based on the data at Week 16.
Least Squares Mean Difference
-53.04
2-Sided
90
-65.44
-40.63
Superiority
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Units
Counts
Participants
OG00038
OG00117
OG00220
OG00342
OG00438
Title
Denominators
Categories
Study Day 2, Week 1
ParticipantsOG00038
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00341
ParticipantsOG00437
Title
Measurements
OG000-0.60± 0.238
OG0010.05± 0.355
OG002-0.64± 0.331
OG003
Study Day 3, Week 1
ParticipantsOG00038
ParticipantsOG00117
ParticipantsOG00220
ParticipantsOG00340
Study Day 4, Week 1
ParticipantsOG00038
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00341
Study Day 5, Week 1
ParticipantsOG00038
ParticipantsOG00116
ParticipantsOG00218
ParticipantsOG00341
Study Day 6, Week 1
ParticipantsOG00038
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00341
Study Day 7, Week 1
ParticipantsOG00037
ParticipantsOG00117
ParticipantsOG00218
ParticipantsOG00338
Study Day 8, Week 1
ParticipantsOG00037
ParticipantsOG00116
ParticipantsOG00220
ParticipantsOG00342
Study Day 9, Week 1
ParticipantsOG00037
ParticipantsOG00117
ParticipantsOG00218
ParticipantsOG00339
Study Day 10, Week 1
ParticipantsOG00037
ParticipantsOG00116
ParticipantsOG00220
ParticipantsOG00340
Study Day 11, Week 1
ParticipantsOG00033
ParticipantsOG00115
ParticipantsOG00219
ParticipantsOG00337
Study Day 12, Week 2
ParticipantsOG00032
ParticipantsOG00116
ParticipantsOG00218
ParticipantsOG00338
Study Day 13, Week 2
ParticipantsOG00034
ParticipantsOG00116
ParticipantsOG00219
ParticipantsOG00341
Study Day 14, Week 2
ParticipantsOG00034
ParticipantsOG00117
ParticipantsOG00220
ParticipantsOG00338
Study Day 15, Week 2
ParticipantsOG00036
ParticipantsOG00116
ParticipantsOG00219
ParticipantsOG00340
Study Day 16, Week 2
ParticipantsOG00034
ParticipantsOG00116
ParticipantsOG00218
ParticipantsOG00337
Week 4
ParticipantsOG00036
ParticipantsOG00117
ParticipantsOG00220
ParticipantsOG00341
Week 8
ParticipantsOG00034
ParticipantsOG00117
ParticipantsOG00220
ParticipantsOG00337
Week 12
ParticipantsOG00034
ParticipantsOG00117
ParticipantsOG00220
ParticipantsOG00338
Week 16
ParticipantsOG00033
ParticipantsOG00117
ParticipantsOG00218
ParticipantsOG00335
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The analysis was based on the data at Week 16.
Least Squares Mean Difference
-1.22
2-Sided
90
-2.52
0.09
Superiority
OG000
OG002
The analysis was based on the data at Week 16.
Least Squares Mean Difference
-1.21
2-Sided
90
-2.46
0.05
Superiority
OG000
OG003
The analysis was based on the data at Week 16.
Least Squares Mean Difference
-3.47
2-Sided
90
-4.51
-2.43
Superiority
OG000
OG004
The analysis was based on the data at Week 16.
Least Squares Mean Difference
-3.66
2-Sided
90
-4.71
-2.61
Superiority
OG001
PF-06826647 50 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Units
Counts
Participants
OG00042
OG00122
OG00221
OG00345
OG00441
Title
Denominators
Categories
Study Day 2, Week 1
Title
Measurements
OG0007.1(2.65 to 17.39)
OG0010(0.00 to 12.60)
OG0024.8(0.50 to 20.57)
OG0036.7(2.47 to 16.17)
OG00412.2(6.05 to 23.04)
Study Day 3, Week 1
Title
Measurements
OG0007.1(2.65 to 17.39)
OG0010(0.00 to 12.60)
OG00219.0(8.58 to 37.19)
OG003
Study Day 4, Week 1
Title
Measurements
OG0009.5(4.22 to 19.38)
OG0014.5(0.48 to 19.56)
OG00214.3(5.37 to 32.81)
OG003
Study Day 5, Week 1
Title
Measurements
OG0007.1(2.65 to 17.39)
OG0019.1(2.44 to 23.60)
OG00214.3(5.37 to 32.81)
OG003
Study Day 6, Week 1
Title
Measurements
OG0004.8(1.27 to 13.53)
OG00113.6(5.12 to 31.13)
OG00219.0(8.58 to 37.19)
OG003
Study Day 7, Week 1
Title
Measurements
OG0009.5(4.22 to 19.38)
OG0019.1(2.44 to 23.60)
OG00219.0(8.58 to 37.19)
OG003
Study Day 8, Week 1
Title
Measurements
OG00011.9(5.91 to 22.74)
OG0019.1(2.44 to 23.60)
OG00214.3(5.37 to 32.81)
OG003
Study Day 9, Week 1
Title
Measurements
OG0009.5(4.22 to 19.38)
OG0019.1(2.44 to 23.60)
OG0029.5(2.56 to 24.50)
OG003
Study Day 10, Week 1
Title
Measurements
OG00011.9(5.91 to 22.74)
OG0014.5(0.48 to 19.56)
OG00219.0(8.58 to 37.19)
OG003
Study Day 11, Week 1
Title
Measurements
OG0009.5(4.22 to 19.38)
OG0014.5(0.48 to 19.56)
OG00219.0(8.58 to 37.19)
OG003
Study Day 12, Week 2
Title
Measurements
OG0004.8(1.27 to 13.53)
OG0014.5(0.48 to 19.56)
OG00219.0(8.58 to 37.19)
OG003
Study Day 13, Week 2
Title
Measurements
OG00011.9(5.91 to 22.74)
OG00118.2(8.17 to 32.25)
OG00214.3(5.37 to 32.81)
OG003
Study Day 14, Week 2
Title
Measurements
OG00011.9(5.91 to 22.74)
OG00122.7(11.49 to 39.52)
OG00214.3(5.37 to 32.81)
OG003
Study Day 15, Week 2
Title
Measurements
OG0004.8(1.27 to 13.53)
OG0019.1(2.44 to 23.60)
OG00214.3(5.37 to 32.81)
OG003
Study Day 16, Week 2
Title
Measurements
OG00014.3(6.41 to 25.56)
OG00113.6(5.12 to 31.13)
OG0029.5(2.56 to 24.50)
OG003
Week 4
Title
Measurements
OG00014.3(6.41 to 25.56)
OG00113.6(5.12 to 31.13)
OG00228.6(13.24 to 46.41)
OG003
Week 8
Title
Measurements
OG00011.9(5.91 to 22.74)
OG00122.7(11.49 to 39.52)
OG00223.8(12.06 to 41.72)
OG003
Week 12
Title
Measurements
OG0007.1(2.65 to 17.39)
OG00131.8(18.11 to 50.00)
OG00228.6(13.24 to 46.41)
OG003
Week 16
Title
Measurements
OG00014.3(6.41 to 25.56)
OG00127.3(12.60 to 44.36)
OG00238.1(20.57 to 58.28)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The analysis was based on the data at Week 16.
Risk Difference (RD)
12.99
2-Sided
90
-4.52
32.87
Superiority
OG000
OG002
The analysis was based on the data at Week 16.
Risk Difference (RD)
23.81
2-Sided
90
2.62
44.64
Superiority
OG000
OG003
The analysis was based on the data at Week 16.
Risk Difference (RD)
41.27
2-Sided
90
23.47
56.18
Superiority
OG000
OG004
The analysis was based on the data at Week 16.
Risk Difference (RD)
49.13
2-Sided
90
30.62
63.69
Superiority
OG001
PF-06826647 50 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Units
Counts
Participants
OG00038
OG00118
OG00221
OG00342
OG00439
Title
Denominators
Categories
Study Day 2, Week 1
ParticipantsOG00038
ParticipantsOG00118
ParticipantsOG00219
ParticipantsOG00342
ParticipantsOG00437
Title
Measurements
OG000-1.51± 0.636
OG001-0.89± 0.927
OG002-1.98± 0.880
OG003
Study Day 3, Week 1
ParticipantsOG00038
ParticipantsOG00118
ParticipantsOG00221
ParticipantsOG00341
Study Day 4, Week 1
ParticipantsOG00038
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00341
Study Day 5, Week 1
ParticipantsOG00038
ParticipantsOG00116
ParticipantsOG00218
ParticipantsOG00341
Study Day 6, Week 1
ParticipantsOG00038
ParticipantsOG00117
ParticipantsOG00219
ParticipantsOG00341
Study Day 7, Week 1
ParticipantsOG00037
ParticipantsOG00117
ParticipantsOG00218
ParticipantsOG00338
Study Day 8, Week 1
ParticipantsOG00037
ParticipantsOG00116
ParticipantsOG00220
ParticipantsOG00342
Study Day 9, Week 1
ParticipantsOG00037
ParticipantsOG00117
ParticipantsOG00218
ParticipantsOG00339
Study Day 10, Week 1
ParticipantsOG00037
ParticipantsOG00117
ParticipantsOG00220
ParticipantsOG00340
Study Day 11, Week 1
ParticipantsOG00033
ParticipantsOG00115
ParticipantsOG00219
ParticipantsOG00337
Study Day 12, Week 2
ParticipantsOG00032
ParticipantsOG00116
ParticipantsOG00219
ParticipantsOG00338
Study Day 13, Week 2
ParticipantsOG00034
ParticipantsOG00116
ParticipantsOG00219
ParticipantsOG00341
Study Day 14, Week 2
ParticipantsOG00034
ParticipantsOG00117
ParticipantsOG00221
ParticipantsOG00338
Study Day 15, Week 2
ParticipantsOG00036
ParticipantsOG00116
ParticipantsOG00220
ParticipantsOG00340
Study Day 16, Week 2
ParticipantsOG00034
ParticipantsOG00116
ParticipantsOG00218
ParticipantsOG00337
Week 4
ParticipantsOG00036
ParticipantsOG00117
ParticipantsOG00220
ParticipantsOG00341
Week 8
ParticipantsOG00034
ParticipantsOG00117
ParticipantsOG00220
ParticipantsOG00337
Week 12
ParticipantsOG00034
ParticipantsOG00117
ParticipantsOG00220
ParticipantsOG00338
Week 16
ParticipantsOG00033
ParticipantsOG00117
ParticipantsOG00218
ParticipantsOG00335
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
The analysis was based on the data at Week 16.
Least Squares Mean Difference
-4.21
2-Sided
90
-7.82
-0.59
Superiority
OG000
OG002
The analysis was based on the data at Week 16.
Least Squares Mean Difference
-6.44
2-Sided
90
-9.89
-2.99
Superiority
OG000
OG003
The analysis was based on the data at Week 16.
Least Squares Mean Difference
-10.51
2-Sided
90
-13.40
-7.62
Superiority
OG000
OG004
The analysis was based on the data at Week 16.
Least Squares Mean Difference
-10.81
2-Sided
90
-13.68
-7.94
Superiority
PF-06826647 50 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Units
Counts
Participants
OG00045
OG00122
OG00223
OG00345
OG00443
Title
Denominators
Categories
Participants with AEs
Title
Measurements
OG00023
OG00113
OG00216
OG00328
OG00429
Participants with SAEs
Title
Measurements
OG0000
OG0011
OG0020
OG003
Participants with severe AEs
Title
Measurements
OG0001
OG0010
OG0021
OG003
Participants discontinued from study due to AEs
Title
Measurements
OG0001
OG0010
OG0020
OG003
Participants discontinued study drug due to AE and continue study
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with dose reduced or temporary discontinuation due to AEs
Title
Measurements
OG0001
OG0011
OG0022
OG003
OG001
PF-06826647 50 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Units
Counts
Participants
OG00045
OG00122
OG00223
OG00345
OG00443
Title
Denominators
Categories
Participants with AEs
Title
Measurements
OG0004
OG0010
OG0024
OG00311
OG0048
Participants with SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with severe AEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants discontinued from study due to AEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants discontinued study drug due to AE and continue study
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with dose reduced or temporary discontinuation due to AEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Units
Counts
Participants
OG00044
OG00122
OG00223
OG00344
OG00443
Title
Denominators
Categories
PR interval, single beat (msec) >=300
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
PR interval, single beat (msec) Pctchg >=25/50%
Title
Measurements
OG0000
OG0010
OG0022
OG003
QRS duration, single beat (msec) >=140
Title
Measurements
OG0001
OG0010
OG0020
OG003
QRS duration, single beat (msec) Pctchg >=50%
Title
Measurements
OG0001
OG0010
OG0021
OG003
450< QTcF- Fridericia's correction formula (msec) <=480
Title
Measurements
OG0001
OG0010
OG0022
OG003
480< QTcF- Fridericia's correction formula (msec) <=500
Title
Measurements
OG0001
OG0010
OG0020
OG003
30< QTcF- Fridericia's correction formula (msec) change <=60
Title
Measurements
OG0000
OG0011
OG0021
OG003
QTcF- Fridericia's correction formula (msec) change >60
Title
Measurements
OG0001
OG0010
OG0021
OG003
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Units
Counts
Participants
OG00045
OG00122
OG00223
OG00345
OG00443
Title
Denominators
Categories
Pulse rate (BMP) >120
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00345
ParticipantsOG00443
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sitting diastolic BP (mmHg) change >=20 increase
ParticipantsOG00045
ParticipantsOG00121
ParticipantsOG00223
ParticipantsOG003
Sitting diastolic BP (mmHg) change >=20 decrease
ParticipantsOG00045
ParticipantsOG00121
ParticipantsOG00223
ParticipantsOG003
Sitting systolic BP (mmHg) <90 increase
ParticipantsOG00045
ParticipantsOG00121
ParticipantsOG00223
ParticipantsOG00345
Sitting systolic BP (mmHg) change >=30 increase
ParticipantsOG00045
ParticipantsOG00121
ParticipantsOG00223
ParticipantsOG003
Sitting systolic BP (mmHg) change >=30 decrease
ParticipantsOG00045
ParticipantsOG00121
ParticipantsOG00223
ParticipantsOG003
OG001
PF-06826647 50 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Units
Counts
Participants
OG00045
OG00122
OG00223
OG00345
OG00443
Title
Denominators
Categories
HGB (g/dL) <0.8*LLN
ParticipantsOG00044
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00345
ParticipantsOG00443
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hematocrit (%) <0.8*LLN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00345
Erythrocytes (10^6/mm^3) <0.8*LLN
ParticipantsOG00041
ParticipantsOG00119
ParticipantsOG00222
ParticipantsOG00342
Reticulocytes (10^3/mm^3) <0.5*LLN
ParticipantsOG00044
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG00342
Reticulocytes (10^3/mm^3) >1.5*ULN
ParticipantsOG00044
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG00342
Ery. Mean Corpuscular Volume (um^3) <0.9*LLN
ParticipantsOG00038
ParticipantsOG00118
ParticipantsOG00220
ParticipantsOG00343
Ery. Mean Corpuscular Volume (um^3) >1.1*ULN
ParticipantsOG00038
ParticipantsOG00118
ParticipantsOG00220
ParticipantsOG00343
Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN
ParticipantsOG00043
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00344
Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN
ParticipantsOG00043
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG003
Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG003
Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG003
Platelets (10^3/mm^3) <0.5*LLN
ParticipantsOG00042
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG00342
Platelets (10^3/mm^3) >1.75*ULN
ParticipantsOG00042
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG00342
Reticulocytes/Erythrocytes (%) <0.5*LLN
ParticipantsOG00044
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG00341
Reticulocytes/Erythrocytes (%) >1.5*ULN
ParticipantsOG00044
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG00341
Leukocytes(10^3/mm^3) <0.6*LLN
ParticipantsOG00044
ParticipantsOG00120
ParticipantsOG00222
ParticipantsOG00341
Leukocytes(10^3/mm^3) >1.5*ULN
ParticipantsOG00044
ParticipantsOG00120
ParticipantsOG00222
ParticipantsOG00341
Lymphocytes/Leukocytes (%) <0.8*LLN
ParticipantsOG00044
ParticipantsOG00119
ParticipantsOG00221
ParticipantsOG00337
Lymphocytes/Leukocytes (%) >1.2*ULN
ParticipantsOG00044
ParticipantsOG00119
ParticipantsOG00221
ParticipantsOG00337
Neutrophils/Leukocytes (%) <0.8*LLN
ParticipantsOG00044
ParticipantsOG00119
ParticipantsOG00220
ParticipantsOG00339
Neutrophils/Leukocytes (%) >1.2*ULN
ParticipantsOG00044
ParticipantsOG00119
ParticipantsOG00220
ParticipantsOG00339
Basophils (10^3/mm^3) >1.2*ULN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00344
Basophils/Leukocytes (%) >1.2*ULN
ParticipantsOG00042
ParticipantsOG00121
ParticipantsOG00221
ParticipantsOG00341
Eosinophils (10^3/mm^3) >1.2*ULN
ParticipantsOG00044
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00345
Eosinophils/Leukocytes (%) >1.2*ULN
ParticipantsOG00045
ParticipantsOG00121
ParticipantsOG00223
ParticipantsOG00343
Monocytes (10^3/mm^3) >1.2*ULN
ParticipantsOG00045
ParticipantsOG00121
ParticipantsOG00223
ParticipantsOG00345
Monocytes/Leukocytes (%) >1.2*ULN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00345
Activated Partial Thromboplastin Time (sec) >1.1*ULN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG003
Prothrombin Time (sec) >1.1*ULN
ParticipantsOG00043
ParticipantsOG00121
ParticipantsOG00222
ParticipantsOG00345
Neutrophils total count (10^3/mm^3) <0.8*LLN
ParticipantsOG00045
ParticipantsOG00120
ParticipantsOG00221
ParticipantsOG00338
Neutrophils total count (10^3/mm^3) >1.2*ULN
ParticipantsOG00045
ParticipantsOG00120
ParticipantsOG00221
ParticipantsOG00338
Lymphocytes total count (10^3/mm^3) <0.8*LLN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00345
Lymphocytes total count (10^3/mm^3) >1.2*ULN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00345
PF-06826647 50 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.
Units
Counts
Participants
OG00045
OG00122
OG00223
OG00345
OG00443
Title
Denominators
Categories
Bilirubin (mg/dL) >1.5*ULN
ParticipantsOG00044
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00343
ParticipantsOG00442
Title
Measurements
OG0000
OG0010
OG0020
OG003
Indirect Bilirubin (mg/dL) >1.5*ULN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00222
ParticipantsOG00343
Aspartate Aminotransferase (U/L) > 3.0*ULN
ParticipantsOG00043
ParticipantsOG00120
ParticipantsOG00223
ParticipantsOG00340
Alanine Aminotransferase (U/L) > 3.0*ULN
ParticipantsOG00040
ParticipantsOG00118
ParticipantsOG00221
ParticipantsOG00338
Gamma Glutamyl Transferase (U/L) > 3.0*ULN
ParticipantsOG00038
ParticipantsOG00121
ParticipantsOG00221
ParticipantsOG00341
Alkaline Phosphatase (U/L) > 3.0*ULN
ParticipantsOG00041
ParticipantsOG00120
ParticipantsOG00222
ParticipantsOG00343
Protein (g/dL) <0.8*LLN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00344
Protein (g/dL) >1.2*ULN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00344
Albumin (g/dL) <0.8*LLN
ParticipantsOG00040
ParticipantsOG00119
ParticipantsOG00220
ParticipantsOG00341
Albumin (g/dL) >1.2*ULN
ParticipantsOG00040
ParticipantsOG00119
ParticipantsOG00220
ParticipantsOG00341
Blood Urea Nitrogen (mg/dL) >1.3*ULN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00345
Urea (mg/dL) >1.3*ULN
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0030
Creatinine (mg/dL) >1.3*ULN
ParticipantsOG00045
ParticipantsOG00121
ParticipantsOG00223
ParticipantsOG00345
Urate (mg/dL) >1.2*ULN
ParticipantsOG00040
ParticipantsOG00120
ParticipantsOG00223
ParticipantsOG00341
HDL Cholesterol (mg/dL) <0.8*LLN
ParticipantsOG00040
ParticipantsOG00121
ParticipantsOG00223
ParticipantsOG00343
Triglycerides (mg/dL) >1.3*ULN
ParticipantsOG00039
ParticipantsOG00120
ParticipantsOG00223
ParticipantsOG00343
Sodium (Meq/L) <0.95*LLN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00345
Sodium (Meq/L) >1.05*ULN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00345
Potassium (Meq/L) <0.9*LLN
ParticipantsOG00045
ParticipantsOG00121
ParticipantsOG00223
ParticipantsOG00345
Potassium (Meq/L) >1.1*ULN
ParticipantsOG00045
ParticipantsOG00121
ParticipantsOG00223
ParticipantsOG00345
Chloride (Meq/L) <0.9*LLN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00344
Chloride (Meq/L) >1.1*ULN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00344
Calcium (mg/dL) <0.9*LLN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00344
Calcium (mg/dL) >1.1*ULN
ParticipantsOG00045
ParticipantsOG00122
ParticipantsOG00223
ParticipantsOG00344
Bicarbonate (Meq/L) <0.9*LLN
ParticipantsOG00044
ParticipantsOG00121
ParticipantsOG00223
ParticipantsOG00345
Bicarbonate (Meq/L) >1.1*ULN
ParticipantsOG00044
ParticipantsOG00121
ParticipantsOG00223
ParticipantsOG00345
Glucose (mg/dL) <0.6*LLN
ParticipantsOG00029
ParticipantsOG00116
ParticipantsOG00218
ParticipantsOG00325
Glucose (mg/dL) >1.5*ULN
ParticipantsOG00029
ParticipantsOG00116
ParticipantsOG00218
ParticipantsOG00325
Creatine Kinase (U/L) >2.0*ULN
ParticipantsOG00042
ParticipantsOG00120
ParticipantsOG00222
ParticipantsOG00342
Cholesterol (mg/dL) >1.3*ULN
ParticipantsOG00038
ParticipantsOG00120
ParticipantsOG00223
ParticipantsOG00338
OG002
PF-06826647 100 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 115 days in investigational treatment period.
OG003
PF-06826647 200 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 120 days in investigational treatment period.
OG004
PF-06826647 400 mg QD Group
This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks). The maximum duration of treatment was 119 days in investigational treatment period.