Dose Ranging Study to Assess Efficacy, Safety, Tolerabili... | NCT03903822 | Trialant
NCT03903822
Sponsor
Pfizer
Status
Completed
Last Update Posted
Mar 29, 2021Actual
Enrollment
292Actual
Phase
Phase 2
Conditions
Atopic Dermatitis
Interventions
PF-06700841
Vehicle (Placebo)
Countries
United States
Australia
Bulgaria
Canada
Denmark
Germany
Hungary
Japan
Latvia
Poland
Protocol Section
Identification Module
NCT ID
NCT03903822
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B7931022
Secondary IDs
ID
Type
Description
Link
2018-003050-24
EudraCT Number
Brief Title
Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis
Official Title
A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 CREAM APPLIED ONCE OR TWICE DAILY FOR 6 WEEKS IN PARTICIPANTS WITH MILD OR MODERATE ATOPIC DERMATITIS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Mar 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
May 13, 2019Actual
Primary Completion Date
May 7, 2020Actual
Completion Date
May 7, 2020Actual
First Submitted Date
Mar 20, 2019
First Submission Date that Met QC Criteria
Apr 2, 2019
First Posted Date
Apr 4, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Jan 20, 2021
Results First Submitted that Met QC Criteria
Mar 3, 2021
Results First Posted Date
Mar 29, 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
Mar 3, 2021
Last Update Posted Date
Mar 29, 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 study is being conducted to provide data on efficacy, safety, tolerability and PK of multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future clinical development of topical PF-06700841.
Detailed Description
Not provided
Conditions Module
Conditions
Atopic Dermatitis
Keywords
Mild-to-Moderate Atopic Dermatitis
topical
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
292Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PF-06700841 0.1% cream QD
Experimental
PF-06700841 0.1% cream applied once daily (QD)
Drug: PF-06700841
PF-06700841 0.3% cream QD
Experimental
PF-06700841 0.3% cream applied once daily (QD)
Drug: PF-06700841
PF-06700841 1% cream QD
Experimental
PF-06700841 1% cream applied once daily (QD)
Drug: PF-06700841
PF-06700841 3% cream QD
Experimental
PF-06700841 3% cream applied once daily (QD)
Drug: PF-06700841
PF-06700841 0.3% cream BID
Experimental
PF-06700841 0.3% cream applied twice daily (BID)
Drug: PF-06700841
PF-06700841 1% cream BID
Experimental
PF-06700841 1% cream applied twice daily (BID)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-06700841
Drug
PF-06700841 topical cream
PF-06700841 0.1% cream QD
PF-06700841 0.3% cream BID
PF-06700841 0.3% cream QD
PF-06700841 1% cream BID
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Baseline, Week 6
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation
IGA assesses severity of participant's AD on a 5 point scale. 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting and 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Higher scores indicating more severity of AD. Assessment excluded soles, palms and scalp.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Atopic Dermatitis for at least 3 months
Investigator's Global Assessment (IGA) Score of 2 or 3
Eczema Area Severity Index (EASI) score of 3-21
Body Surface Area (BSA) of 2-20%
Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more
Exclusion Criteria:
Other forms of dermatological diseases (other than atopic dermatitis)
Fitzpatrick skin type score greater than 5
Clinically significant abnormal ECG, vital signs, and laboratory values
Infection with HBV, HCV, herpes zoster or tuberculosis
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
12 Years
Maximum Age
75 Years
Standard Ages
ChildAdultOlder 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
Clinical Research Center of Alabama, LLC
Birmingham
Alabama
35244
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.
Participants or caregivers of participants, topically applied vehicle cream on all eligible atopic dermatitis (AD) areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Baseline, Week 6
Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Baseline, Weeks 1, 2, 3, 4 and 6
Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit
4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD.
Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Baseline, Weeks 1, 2, 3, 4 and 6
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. 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; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.
Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Number of Participants With Pre-defined Criteria For Vital Signs
Pre-defined criteria included: 1) Diastolic blood pressure (DBP), a) sitting DBP: change of >= 20 millimeter of mercury (mmHg) increase, b) sitting DBP: change of >=20mmHg decrease, c) supine DBP: less than (<) 50 mmHg, d) supine DBP: change of >= 20mmHg increase, e) supine DBP: change of >= 20mmHg decrease; 2) Systolic blood pressure (SBP), a) sitting SBP: <90 mmHg, b) sitting SBP: change of >=30mmHg increase, c) sitting SBP: change of >=30mmHg decrease, d) supine SBP: change of >=30mmHg increase, e) supine SBP: change of >=30mmHg decrease and f) Supine SBP: value <90mmHg.
Baseline up to Week 6
Number of Participants With Laboratory Abnormalities
Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
Clinically significant ECG criteria included PR interval: value greater than (>) 280 millisecond (msec), percentage change greater than equal to (>=) 25/50 percentage, QRS interval: value >120 msec, percentage change >= 50% and QT interval corrected using the Fridericia's formula (QTCF) value 450 msec and 30<=change<60.
Baseline up to Week 6
Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Change From Baseline in Lipids Profile Values at Week 6
Lipid parameters that were assessed: high density lipoprotein (HDL) cholesterol, triglycerides, cholesterol, low density lipoprotein (LDL) cholesterol.
Baseline, Week 6
Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6
Mean change in total cholesterol/HDL cholesterol ratio was assessed and reported.
Baseline, Week 6
Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6
Baseline, Weeks 2 and 6
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
Baseline, Weeks 2 and 6
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Blood pressure included supine and sitting systolic and diastolic BP.
Baseline, Weeks 2 and 6
Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6
Baseline, Weeks 2 and 6
Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6
Baseline, Weeks 2 and 6
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Local tolerability skin assessments were performed by the investigator and graded based on severity from grade 0 to 4 as: grade 0=none (no evidence of local intolerance); grade 1=mild (minimal erythema and/or oedema, slight glazed appearance); grade 2= moderate (definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology) grade 3=severe (erythema, oedema glazing with fissures, few vesicles or papules consider removing topical agent [if still in place]) and grade 4= very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent [if still in place]). Higher grades indicated worsening of condition. Only those categories in which at least 1 participant had data were reported.
Day 1 and any day on of Week 1, 2, 4, 6: pre dose (before application of IP) and post dose (after application of IP); Follow up visit (28 days after last dose of study drug = maximum up to Day 71) and Early termination (anytime within week 11)
Scottsdale
Arizona
85260
United States
Center for Dermatology and Plastic Surgery
Scottsdale
Arizona
85260
United States
California Dermatology & Clinical Research Institute
Encinitas
California
92024
United States
First OC Dermatology
Fountain Valley
California
92708
United States
Beach Allergy and Asthma Specialty Group, A Medical Corporation
Long Beach
California
90808
United States
Clinical Science Institute
Santa Monica
California
90404
United States
New England Associates, LLC
Bridgeport
Connecticut
06606
United States
Dermatology Physicians of Connecticut
Shelton
Connecticut
06484
United States
Yolanda C. Holmes, MD
Washington D.C.
District of Columbia
20036
United States
Olympian Clinical Research
Clearwater
Florida
33756
United States
Accel Research Sites - DeLand Clinical Research Unit
DeLand
Florida
32720
United States
Jacksonville Center for Clinical Research
Jacksonville
Florida
32216
United States
Clinical Neuroscience Solutions, Inc.
Jacksonville
Florida
32256
United States
Precision Imaging
Jacksonville
Florida
32256
United States
Solutions Through Advanced Research, Inc
Jacksonville
Florida
32256
United States
Clinical Neuroscience Solutions, Inc.
Orlando
Florida
32801
United States
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
Ormond Beach
Florida
32174
United States
Advanced Medical Research PC
Sandy Springs
Georgia
30328
United States
Sneeze, Wheeze & Itch Associates, LLC
Normal
Illinois
61761
United States
DS Research
New Albany
Indiana
47150
United States
DS Research
Louisville
Kentucky
40241
United States
Meridian Clinical Research, LLC
Baton Rouge
Louisiana
70808
United States
MediSearch Clinical Trials
Saint Joseph
Missouri
64506
United States
Dermatology Consulting Services, PLLC
High Point
North Carolina
27262
United States
Lynn Health Science Institute
Oklahoma City
Oklahoma
73112
United States
Vital Prospects Clinical Research Institute, PC
Tulsa
Oklahoma
74136
United States
Health Concepts
Rapid City
South Dakota
57702
United States
Tanenbaum Dermatology Center
Memphis
Tennessee
38117
United States
Clinical Neuroscience Solutions, Inc.
Memphis
Tennessee
38119
United States
studies in Dermatology, LLC
Cypress
Texas
77433
United States
Center for Clinical Studies, LTD.LLP
Houston
Texas
77004
United States
Ventavia Research Group LLC
Hurst
Texas
76054
United States
Center for Clinical Studies, LTD. LLP
Webster
Texas
77598
United States
Summit Clinical Research, LLC
Franklin
Virginia
23851
United States
Virginia Dermatology and Skin Cancer Center
Norfolk
Virginia
23502
United States
Australian Clinical Research Network
Maroubra
New South Wales
2035
Australia
Emeritus Research
Camberwell
Victoria
3124
Australia
Sinclair Dermatology
East Melbourne
Victoria
3002
Australia
Cabrini Hospital
Malvern
Victoria
3144
Australia
Center for Skin and Venereal Diseases EOOD - Sofia
Sofia
1404
Bulgaria
DCC Alexandrovska
Sofia
1431
Bulgaria
Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
Sofia
1463
Bulgaria
Wiseman Dermatology Research Inc.
Winnipeg
Manitoba
R3M 3Z4
Canada
SKiN Health
Cobourg
Ontario
K9A 4J9
Canada
Innovaderm Research Inc.
Montreal
Quebec
H2X 2V1
Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke
Quebec
J1L 0H8
Canada
Gentofte Hospital
Hellerup
2900
Denmark
Emovis GmbH
Berlin
10629
Germany
Rothhaar Studien GmbH
Berlin
10783
Germany
ISA - Interdisciplinary Study Association GmbH
Berlin
10789
Germany
Klinikum Bielefeld gem.GmbH
Bielefeld
33647
Germany
Universitätsklinikum Bonn AöR
Bonn
53127
Germany
Universitätsklinikum Frankfurt
Frankfurt
60590
Germany
MENSINGDERMA research GmbH
Hamburg
22391
Germany
MVZ Alstermed GmbH
Hamburg
22391
Germany
Dermatologische Gemeinschaftspraxis
Mahlow
15831
Germany
Klinische Forschung Schwerin GmbH
Schwerin
19055
Germany
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
Budapest
1085
Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen
4032
Hungary
Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza
Participants or caregivers of participants, topically applied PF-06700841 0.1 percent (%) cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
FG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
FG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
FG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
FG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
FG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
FG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
FG00037 subjects
FG00137 subjects
FG00236 subjects
FG00337 subjects
FG00436 subjects
FG00536 subjects
FG00636 subjects
FG00737 subjects
COMPLETED
FG00028 subjects
FG00127 subjects
FG00233 subjects
FG00332 subjects
FG00431 subjects
FG00525 subjects
FG00631 subjects
FG00733 subjects
NOT COMPLETED
FG0009 subjects
FG00110 subjects
FG0023 subjects
FG0035 subjects
FG0045 subjects
FG00511 subjects
FG0065 subjects
FG0074 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0013 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
FG0056 subjects
FG0061 subjects
FG0070 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0014 subjects
FG0022 subjects
FG0032 subjects
FG004
Refused Further Treatment
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Follow up Phase (4 Weeks)
Type
Comment
Milestone Data
STARTED
FG00037 subjectsParticipants not completing treatment phase could also start this phase.
FG00137 subjectsParticipants not completing treatment phase could also start this phase.
FG00236 subjectsParticipants not completing treatment phase could also start this phase.
FG00337 subjectsParticipants not completing treatment phase could also start this phase.
FG00436 subjectsParticipants not completing treatment phase could also start this phase.
FG00536 subjectsParticipants not completing treatment phase could also start this phase.
FG00636 subjectsParticipants not completing treatment phase could also start this phase.
FG00737 subjectsParticipants not completing treatment phase could also start this phase.
COMPLETED
FG00029 subjects
FG00129 subjects
FG00232 subjects
FG00333 subjects
FG004
NOT COMPLETED
FG0008 subjects
FG0018 subjects
FG0024 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0012 subjects
FG0021 subjects
FG003
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
BG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
BG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
BG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
BG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
BG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
BG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
BG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00037
BG00137
BG00236
BG00337
BG00436
BG00536
BG00636
BG00737
BG008292
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00039.1± 16.80
BG00140.8± 15.35
BG00243.4± 16.43
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00020
BG00119
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
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
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Missing data were imputed with multiple imputation method assuming responses are similar to the corresponding vehicle arm under the MAR assumption
Posted
Least Squares Mean
90% Confidence Interval
Percent change
Baseline, Week 6
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00037
OG00137
OG00236
OG003
Title
Denominators
Categories
Title
Measurements
OG000-44.4(-57.3 to -31.6)
OG001-58.3(-71.2 to -45.5)
OG002-64.6(-77.1 to -52.1)
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
Analysis of covariance (ANCOVA) contained fixed factors of treatment and baseline value.
ANCOVA
0.1040
Least square (LS) mean difference
-13.9
Standard Error of the Mean
11.04
2-Sided
90
-32.1
4.3
Superiority
OG000
OG002
ANCOVA contained fixed factors of treatment and baseline value.
Secondary
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation
IGA assesses severity of participant's AD on a 5 point scale. 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting and 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Higher scores indicating more severity of AD. Assessment excluded soles, palms and scalp.
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Non-Responder Imputation (NRI) method: participants with missing values were considered to be non-responders.
Posted
Number
90% Confidence Interval
Percentage of participants
Baseline, Week 6
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Secondary
Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Missing data were imputed with multiple imputation method assuming responses are similar to the corresponding vehicle arm under the MAR assumption
Posted
Least Squares Mean
90% Confidence Interval
Units on a scale
Baseline, Week 6
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Secondary
Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. NRI method: participants with missing values were considered to be non-responders.
Posted
Number
90% Confidence Interval
Percentage of participants
Baseline, Weeks 1, 2, 3, 4 and 6
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Secondary
Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. NRI method: participants with missing values were considered to be non-responders.
Posted
Number
90% Confidence Interval
Percentage of participants
Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Secondary
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit
4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD.
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Posted
Least Squares Mean
90% Confidence Interval
Percent change
Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Secondary
Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Full analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. NRI method: participants with missing values were considered to be non-responders.
Posted
Number
90% Confidence Interval
Percentage of participants
Baseline, Weeks 1, 2, 3, 4 and 6
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. 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; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug.
Posted
Count of Participants
Participants
Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Secondary
Number of Participants With Pre-defined Criteria For Vital Signs
Pre-defined criteria included: 1) Diastolic blood pressure (DBP), a) sitting DBP: change of >= 20 millimeter of mercury (mmHg) increase, b) sitting DBP: change of >=20mmHg decrease, c) supine DBP: less than (<) 50 mmHg, d) supine DBP: change of >= 20mmHg increase, e) supine DBP: change of >= 20mmHg decrease; 2) Systolic blood pressure (SBP), a) sitting SBP: <90 mmHg, b) sitting SBP: change of >=30mmHg increase, c) sitting SBP: change of >=30mmHg decrease, d) supine SBP: change of >=30mmHg increase, e) supine SBP: change of >=30mmHg decrease and f) Supine SBP: value <90mmHg.
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Posted
Count of Participants
Participants
Baseline up to Week 6
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Secondary
Number of Participants With Laboratory Abnormalities
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Secondary
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
Clinically significant ECG criteria included PR interval: value greater than (>) 280 millisecond (msec), percentage change greater than equal to (>=) 25/50 percentage, QRS interval: value >120 msec, percentage change >= 50% and QT interval corrected using the Fridericia's formula (QTCF) value 450 msec and 30<=change<60.
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Baseline up to Week 6
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Secondary
Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Posted
Mean
Standard Deviation
Units per liter
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Secondary
Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Posted
Mean
Standard Deviation
Gram per deciliter
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Secondary
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Posted
Mean
Standard Deviation
Microgram per deciliter
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Secondary
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Posted
Mean
Standard Deviation
Milliequivalents per liter
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Secondary
Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Posted
Mean
Standard Deviation
Gram per deciliter
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Secondary
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Posted
Mean
Standard Deviation
Percentage of cells
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Secondary
Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Posted
Mean
Standard Deviation
10^12*cells per liter
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Secondary
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Posted
Mean
Standard Deviation
10^9 *cells per liter
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
Secondary
Change From Baseline in Lipids Profile Values at Week 6
Lipid parameters that were assessed: high density lipoprotein (HDL) cholesterol, triglycerides, cholesterol, low density lipoprotein (LDL) cholesterol.
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Posted
Mean
Standard Deviation
Microgram per deciliter
Baseline, Week 6
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
Secondary
Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6
Mean change in total cholesterol/HDL cholesterol ratio was assessed and reported.
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Posted
Mean
Standard Deviation
Ratio
Baseline, Week 6
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Secondary
Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "number analyzed" signifies participants evaluable for the each specified time point.
Posted
Mean
Standard Deviation
Beats per minute
Baseline, Weeks 2 and 6
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Secondary
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "number analyzed" signifies participants evaluable for the each specified time point.
Posted
Mean
Standard Deviation
Milliseconds
Baseline, Weeks 2 and 6
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Secondary
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Blood pressure included supine and sitting systolic and diastolic BP.
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for the each specified time point.
Posted
Mean
Standard Deviation
Millimeters of mercury
Baseline, Weeks 2 and 6
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Secondary
Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "number analyzed" signifies participants evaluable for the each specified time point.
Posted
Mean
Standard Deviation
Beats per minute
Baseline, Weeks 2 and 6
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Secondary
Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug. Here, "number analyzed" signifies participants evaluable for the each specified time point.
Posted
Mean
Standard Deviation
Degree Celsius
Baseline, Weeks 2 and 6
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Secondary
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Local tolerability skin assessments were performed by the investigator and graded based on severity from grade 0 to 4 as: grade 0=none (no evidence of local intolerance); grade 1=mild (minimal erythema and/or oedema, slight glazed appearance); grade 2= moderate (definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology) grade 3=severe (erythema, oedema glazing with fissures, few vesicles or papules consider removing topical agent [if still in place]) and grade 4= very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent [if still in place]). Higher grades indicated worsening of condition. Only those categories in which at least 1 participant had data were reported.
Safety analysis set included all participants who were randomly assigned to study drug and who applied at least 1 dose of study drug.
Posted
Count of Participants
Participants
Day 1 and any day on of Week 1, 2, 4, 6: pre dose (before application of IP) and post dose (after application of IP); Follow up visit (28 days after last dose of study drug = maximum up to Day 71) and Early termination (anytime within week 11)
ID
Title
Description
OG000
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Time Frame
Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Description
Not provided
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
Vehicle Cream Once Daily (QD)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
0
37
0
37
18
37
EG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
0
37
0
37
17
37
EG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
0
36
0
36
11
36
EG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
0
37
0
37
12
37
EG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
0
36
0
36
10
36
EG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
0
36
0
36
17
36
EG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
0
36
0
36
9
36
EG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
0
37
0
37
14
37
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Swelling of eyelid
Eye disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG0030 affected37 at risk
EG0040 affected36 at risk
EG0050 affected36 at risk
EG0061 affected36 at risk
EG0070 affected37 at risk
Ulcerative keratitis
Eye disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Administration site warmth
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Application site acne
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Application site erythema
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Application site pain
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Application site pruritus
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Chills
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Injection site pain
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Oedema peripheral
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Pain
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0021 affected36 at risk
EG003
Pyrexia
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Vessel puncture site haematoma
General disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Allergy to arthropod sting
Immune system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Cockroach allergy
Immune system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Mite allergy
Immune system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Bacterial allergy
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Cystitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Eczema infected
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Folliculitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Furuncle
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0021 affected36 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Gingivitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0021 affected36 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Influenza
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Kaposi's varicelliform eruption
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Laryngitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0012 affected37 at risk
EG0022 affected36 at risk
EG003
Oral herpes
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Rhinitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Skin infection
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0021 affected36 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0022 affected36 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Viral infection
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Viral rhinitis
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0021 affected36 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0021 affected36 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0021 affected36 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0021 affected36 at risk
EG003
Blood glucose increased
Investigations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0021 affected36 at risk
EG003
Electrocardiogram T wave inversion
Investigations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Glomerular filtration rate decreased
Investigations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Lipids abnormal
Investigations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0021 affected36 at risk
EG003
Pregnancy test positive
Investigations
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Headache
Nervous system disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0021 affected36 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0022 affected36 at risk
EG003
Increased viscosity of bronchial secretion
Respiratory, thoracic and mediastinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0012 affected37 at risk
EG0021 affected36 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0003 affected37 at risk
EG0013 affected37 at risk
EG0021 affected36 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Granuloma annulare
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0002 affected37 at risk
EG0011 affected37 at risk
EG0020 affected36 at risk
EG003
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Solar urticaria
Skin and subcutaneous tissue disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Haematoma
Vascular disorders
MedDRA v23.0
Non-systematic Assessment
EG0001 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 at risk
EG003
Allergy to animal
Immune system disorders
MedDRA v23.0
Non-systematic Assessment
EG0000 affected37 at risk
EG0010 affected37 at risk
EG0020 affected36 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.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872
Dermatitis
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D017443
Skin Diseases, Eczematous
D006969
Hypersensitivity, Immediate
D006967
Hypersensitivity
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000630838
PF-06700841
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
1 subjects
FG0052 subjects
FG0063 subjects
FG0073 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
1 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
32 subjects
FG00528 subjects
FG00631 subjects
FG00731 subjects
4 subjects
FG0058 subjects
FG0065 subjects
FG0076 subjects
1 subjects
FG0040 subjects
FG0055 subjects
FG0061 subjects
FG0070 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0073 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Withdrawal by Subject
FG0002 subjects
FG0015 subjects
FG0023 subjects
FG0032 subjects
FG0042 subjects
FG0052 subjects
FG0063 subjects
FG0073 subjects
Refused Further Study Procedures
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Other
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
38.4
± 12.90
BG00440.5± 12.30
BG00542.3± 18.18
BG00639.4± 17.27
BG00738.1± 15.34
BG00840.2± 15.59
24
BG00323
BG00415
BG00519
BG00616
BG00720
BG008156
Male
BG00017
BG00118
BG00212
BG00314
BG00421
BG00517
BG00620
BG00717
BG008136
3
BG0032
BG0041
BG0053
BG0060
BG0074
BG00813
Not Hispanic or Latino
BG00037
BG00137
BG00232
BG00335
BG00435
BG00533
BG00635
BG00733
BG008277
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0030
BG0040
BG0050
BG0061
BG0070
BG0082
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Asian
BG0004
BG0018
BG0024
BG0038
BG00410
BG0059
BG0069
BG0077
BG00859
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0031
BG0040
BG0051
BG0060
BG0070
BG0082
Black or African American
BG0008
BG0017
BG0029
BG0036
BG0044
BG0056
BG0065
BG0076
BG00851
White
BG00024
BG00122
BG00221
BG00320
BG00421
BG00520
BG00622
BG00724
BG008174
More than one race
BG0000
BG0010
BG0022
BG0032
BG0041
BG0050
BG0060
BG0070
BG0085
Unknown or Not Reported
BG0001
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0081
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
37
OG00436
OG00536
OG00636
OG00737
-70.1
(-82.1 to -58.0)
OG004-67.9(-80.6 to -55.3)
OG005-47.6(-57.5 to -37.7)
OG006-58.6(-67.5 to -49.7)
OG007-75.0(-83.8 to -66.2)
ANCOVA
0.0334
LS Mean Difference
-20.2
Standard Error of the Mean
11.00
2-Sided
90
-38.3
-2.1
Superiority
OG000
OG003
ANCOVA contained fixed factors of treatment and baseline value.
ANCOVA
0.0086
LS Mean Difference
-25.6
Standard Error of the Mean
10.75
2-Sided
90
-43.3
-8.0
Superiority
OG000
OG004
ANCOVA contained fixed factors of treatment and baseline value.
ANCOVA
0.0158
LS Mean Difference
-23.5
Standard Error of the Mean
10.93
2-Sided
90
-41.5
-5.5
Superiority
OG005
OG006
ANCOVA contained fixed factors of treatment and baseline value.
ANCOVA
0.0879
LS Mean Difference
-11.0
Standard Error of the Mean
8.11
2-Sided
90
-24.3
2.4
Superiority
OG005
OG007
ANCOVA contained fixed factors of treatment and baseline value.
ANCOVA
0.0004
LS Mean Difference
-27.4
Standard Error of the Mean
8.11
2-Sided
90
-40.7
-14.1
Superiority
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00037
OG00137
OG00236
OG00337
OG00436
OG00536
OG00636
OG00737
Title
Denominators
Categories
Title
Measurements
OG00010.8(4.8 to 22.2)
OG00129.7(18.5 to 43.3)
OG00233.3(21.3 to 47.0)
OG00340.5(28.0 to 54.4)
OG00444.4(30.2 to 59.1)
OG00513.9(6.9 to 25.4)
OG00633.3(21.3 to 47.0)
OG00727.0(15.5 to 40.2)
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
Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0244
Risk Difference (RD)
18.9
2-Sided
90
2.4
34.7
Superiority
OG000
OG002
Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0113
Risk Difference (RD)
22.5
2-Sided
90
4.8
38.6
Superiority
OG000
OG003
Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0018
Risk Difference (RD)
29.7
2-Sided
90
11.0
45.7
Superiority
OG000
OG004
Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0007
Risk Difference (RD)
33.6
2-Sided
90
13.7
49.9
Superiority
OG005
OG006
Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0289
Risk Difference (RD)
19.4
2-Sided
90
1.8
36.5
Superiority
OG005
OG007
Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1145
Risk Difference (RD)
13.1
2-Sided
90
-2.9
29.6
Superiority
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00037
OG00137
OG00236
OG00337
OG00436
OG00536
OG00636
OG00737
Title
Denominators
Categories
Title
Measurements
OG000-3.2(-4.1 to -2.3)
OG001-4.5(-5.4 to -3.6)
OG002-4.6(-5.5 to -3.7)
OG003-4.8(-5.7 to -3.9)
OG004-5.5(-6.4 to -4.7)
OG005-3.6(-4.3 to -3.0)
OG006-4.4(-5.0 to -3.8)
OG007-5.3(-5.9 to -4.7)
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
ANCOVA contained fixed factors of treatment and baseline value.
ANCOVA
0.0488
LS mean difference
-1.31
Standard Error of the Mean
0.790
2-Sided
90
-2.61
-0.01
Superiority
OG000
OG002
ANCOVA contained fixed factors of treatment and baseline value.
ANCOVA
0.0413
LS Mean Difference
-1.37
Standard Error of the Mean
0.788
2-Sided
90
-2.66
-0.07
Superiority
OG000
OG003
ANCOVA contained fixed factors of treatment and baseline value.
ANCOVA
0.0200
LS Mean Difference
-1.59
Standard Error of the Mean
0.773
2-Sided
90
-2.86
-0.32
Superiority
OG000
OG004
ANCOVA contained fixed factors of treatment and baseline value.
ANCOVA
0.0011
LS Mean Difference
-2.33
Standard Error of the Mean
0.758
2-Sided
90
-3.58
-1.08
Superiority
OG005
OG006
ANCOVA contained fixed factors of treatment and baseline value.
ANCOVA
0.0727
LS Mean Difference
-0.78
Standard Error of the Mean
0.535
2-Sided
90
-1.66
0.10
Superiority
OG005
OG007
ANCOVA contained fixed factors of treatment and baseline value.
ANCOVA
0.0010
LS Mean Difference
-1.64
Standard Error of the Mean
0.534
2-Sided
90
-2.52
-0.77
Superiority
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00037
OG00136
OG00235
OG00337
OG00436
OG00536
OG00635
OG00735
Title
Denominators
Categories
At Week 1
Title
Measurements
OG00016.2(7.3 to 29.3)
OG00116.7(7.5 to 30.2)
OG00220.0(11.0 to 33.8)
OG00329.7(18.5 to 43.3)
OG00444.4(30.2 to 59.1)
OG00513.9(6.9 to 25.4)
OG00628.6(16.4 to 41.9)
OG00725.7(15.4 to 39.2)
At Week 2
Title
Measurements
OG00024.3(14.5 to 37.0)
OG00130.6(18.9 to 44.0)
OG00242.9(30.0 to 58.1)
OG003
At Week 3
Title
Measurements
OG00021.6(11.2 to 34.3)
OG00138.9(25.4 to 53.0)
OG00248.6(33.8 to 63.5)
OG003
At Week 4
Title
Measurements
OG00035.1(22.2 to 49.3)
OG00138.9(25.4 to 53.0)
OG00251.4(36.5 to 66.2)
OG003
At Week 6
Title
Measurements
OG00040.5(28.0 to 54.4)
OG00141.7(29.0 to 56.0)
OG00251.4(36.5 to 66.2)
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
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.5246
Risk Difference (RD)
0.5
2-Sided
90
-14.7
16.4
Superiority
OG000
OG002
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.3906
Risk Difference (RD)
3.8
2-Sided
90
-12.5
19.9
Superiority
OG000
OG003
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1193
Risk Difference (RD)
13.5
2-Sided
90
-3.2
30.6
Superiority
OG000
OG004
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0048
Risk Difference (RD)
28.2
2-Sided
90
8.8
45.5
Superiority
OG005
OG006
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0777
Risk Difference (RD)
14.7
2-Sided
90
-2.0
31.1
Superiority
OG005
OG007
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1245
Risk Difference (RD)
11.8
2-Sided
90
-4.3
28.0
Superiority
OG000
OG001
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.3322
Risk Difference (RD)
6.2
2-Sided
90
-12.2
24.4
Superiority
OG000
OG002
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0535
Risk Difference (RD)
18.5
2-Sided
90
-0.3
36.5
Superiority
OG000
OG003
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0159
Risk Difference (RD)
24.3
2-Sided
90
4.5
41.9
Superiority
OG000
OG004
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0008
Risk Difference (RD)
36.8
2-Sided
90
15.4
54.0
Superiority
OG005
OG006
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0386
Risk Difference (RD)
20.7
2-Sided
90
1.5
38.8
Superiority
OG005
OG007
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1485
Risk Difference (RD)
12.1
2-Sided
90
-6.4
30.3
Superiority
OG000
OG001
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0620
Risk Difference (RD)
17.3
2-Sided
90
-0.8
34.8
Superiority
OG000
OG002
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0089
Risk Difference (RD)
26.9
2-Sided
90
6.5
44.4
Superiority
OG000
OG003
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0005
Risk Difference (RD)
37.8
2-Sided
90
17.5
54.7
Superiority
OG000
OG004
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0007
Risk Difference (RD)
36.7
2-Sided
90
15.4
54.0
Superiority
OG005
OG006
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0711
Risk Difference (RD)
18.1
2-Sided
90
-2.0
37.5
Superiority
OG005
OG007
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0266
Risk Difference (RD)
23.8
2-Sided
90
2.7
42.5
Superiority
OG000
OG001
At week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.4173
Risk Difference (RD)
3.8
2-Sided
90
-15.3
23.1
Superiority
OG000
OG002
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1096
Risk Difference (RD)
16.3
2-Sided
90
-4.3
35.6
Superiority
OG000
OG003
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0133
Risk Difference (RD)
27.0
2-Sided
90
6.1
45.7
Superiority
OG000
OG004
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0304
Risk Difference (RD)
23.2
2-Sided
90
2.6
41.7
Superiority
OG005
OG006
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0078
Risk Difference (RD)
29.4
2-Sided
90
7.2
47.6
Superiority
OG005
OG007
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0078
Risk Difference (RD)
29.4
2-Sided
90
7.2
47.6
Superiority
OG000
OG001
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.4966
Risk Difference (RD)
1.1
2-Sided
90
-18.4
20.4
Superiority
OG000
OG002
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.2753
Risk Difference (RD)
10.9
2-Sided
90
-9.3
30.1
Superiority
OG000
OG003
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1036
Risk Difference (RD)
16.2
2-Sided
90
-4.2
35.7
Superiority
OG000
OG004
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0457
Risk Difference (RD)
20.6
2-Sided
90
0.4
39.6
Superiority
OG005
OG006
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0078
Risk Difference (RD)
29.4
2-Sided
90
7.2
47.6
Superiority
OG005
OG007
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0078
Risk Difference (RD)
29.4
2-Sided
90
7.2
47.6
Superiority
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00033
OG00130
OG00232
OG00331
OG00428
OG00530
OG00630
OG00727
Title
Denominators
Categories
At Week 1
Title
Measurements
OG0000.0(0.0 to 8.2)
OG0013.3(0.4 to 14.0)
OG0023.1(0.3 to 13.1)
OG00316.1(8.1 to 29.7)
OG00410.7(4.0 to 23.8)
OG0053.3(0.4 to 14.0)
OG0063.3(0.4 to 14.0)
OG00711.1(4.2 to 24.8)
At Week 2
Title
Measurements
OG0009.1(3.4 to 20.2)
OG00110.0(3.7 to 22.1)
OG0029.4(3.5 to 20.7)
OG003
At Week 3
Title
Measurements
OG00012.1(5.4 to 25.1)
OG00123.3(12.9 to 37.6)
OG00215.6(7.8 to 28.7)
OG003
At Week 4
Title
Measurements
OG00018.2(8.2 to 31.3)
OG00126.7(14.0 to 41.6)
OG00228.1(17.0 to 43.3)
OG003
At Week 6
Title
Measurements
OG00018.2(8.2 to 31.3)
OG00130.0(18.2 to 45.5)
OG00234.4(20.7 to 50.0)
OG003
At Follow-up visit
Title
Measurements
OG0009.1(3.4 to 20.2)
OG00130.0(18.2 to 45.5)
OG00221.9(12.1 to 36.2)
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
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.2450
Risk Difference (RD)
3.3
2-Sided
90
-5.4
14.9
Superiority
OG000
OG002
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.2575
Risk Difference (RD)
3.1
2-Sided
90
-5.3
14.0
Superiority
OG000
OG003
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0087
Risk Difference (RD)
16.1
2-Sided
90
5.7
31.0
Superiority
OG000
OG004
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0392
Risk Difference (RD)
10.7
2-Sided
90
0.8
25.4
Superiority
OG005
OG006
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
1.0000
Risk Difference (RD)
0.0
2-Sided
90
-11.2
11.2
Superiority
OG005
OG007
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1528
Risk Difference (RD)
7.8
2-Sided
90
-4.9
22.5
Superiority
OG000
OG001
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.4989
Risk Difference (RD)
0.9
2-Sided
90
-12.7
15.2
Superiority
OG000
OG002
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.5419
Risk Difference (RD)
0.3
2-Sided
90
-13.6
14.2
Superiority
OG000
OG003
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1362
Risk Difference (RD)
10.3
2-Sided
90
-5.0
26.2
Superiority
OG000
OG004
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0541
Risk Difference (RD)
15.9
2-Sided
90
-0.4
33.9
Superiority
OG005
OG006
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.3945
Risk Difference (RD)
3.3
2-Sided
90
-12.0
19.5
Superiority
OG005
OG007
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0201
Risk Difference (RD)
23.3
2-Sided
90
3.9
41.8
Superiority
OG000
OG001
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1372
Risk Difference (RD)
11.2
2-Sided
90
-5.4
28.2
Superiority
OG000
OG002
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.3924
Risk Difference (RD)
3.5
2-Sided
90
-11.6
19.1
Superiority
OG000
OG003
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0311
Risk Difference (RD)
20.1
2-Sided
90
2.4
38.3
Superiority
OG000
OG004
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0392
Risk Difference (RD)
20.0
2-Sided
90
0.8
38.1
Superiority
OG005
OG006
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1541
Risk Difference (RD)
10.0
2-Sided
90
-6.2
26.4
Superiority
OG005
OG007
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0091
Risk Difference (RD)
27.0
2-Sided
90
6.8
45.4
Superiority
OG000
OG001
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.2835
Risk Difference (RD)
8.5
2-Sided
90
-9.5
27.0
Superiority
OG000
OG002
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.2700
Risk Difference (RD)
9.9
2-Sided
90
-8.7
27.8
Superiority
OG000
OG003
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0662
Risk Difference (RD)
17.3
2-Sided
90
-1.4
36.2
Superiority
OG000
OG004
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0050
Risk Difference (RD)
31.8
2-Sided
90
9.2
50.4
Superiority
OG005
OG006
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0302
Risk Difference (RD)
20.0
2-Sided
90
2.2
38.3
Superiority
OG005
OG007
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0091
Risk Difference (RD)
27.0
2-Sided
90
6.8
45.4
Superiority
OG000
OG001
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1561
Risk Difference (RD)
11.8
2-Sided
90
-6.5
30.2
Superiority
OG000
OG002
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0753
Risk Difference (RD)
16.2
2-Sided
90
-2.7
34.8
Superiority
OG000
OG003
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0108
Risk Difference (RD)
27.0
2-Sided
90
5.7
46.0
Superiority
OG000
OG004
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0050
Risk Difference (RD)
31.8
2-Sided
90
9.2
50.4
Superiority
OG005
OG006
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0775
Risk Difference (RD)
16.7
2-Sided
90
-2.9
35.7
Superiority
OG005
OG007
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0243
Risk Difference (RD)
24.1
2-Sided
90
3.4
43.4
Superiority
OG000
OG001
At follow-up visit: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0234
Risk Difference (RD)
20.9
2-Sided
90
3.5
38.8
Superiority
OG000
OG002
At follow-up visit: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1134
Risk Difference (RD)
12.8
2-Sided
90
-2.8
29.3
Superiority
OG000
OG003
At follow-up visit: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1362
Risk Difference (RD)
10.3
2-Sided
90
-5.0
26.2
Superiority
OG000
OG004
At follow-up visit: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1029
Risk Difference (RD)
12.3
2-Sided
90
-3.4
29.8
Superiority
OG005
OG006
At follow-up visit: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
1.0000
Risk Difference (RD)
0.0
2-Sided
90
-17.9
17.9
Superiority
OG005
OG007
At follow-up visit: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.8972
Risk Difference (RD)
-12.6
2-Sided
90
-28.8
3.5
Superiority
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00034
OG00136
OG00233
OG00335
OG00434
OG00534
OG00636
OG00736
Title
Denominators
Categories
At Week 1
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00335
ParticipantsOG00434
ParticipantsOG00534
ParticipantsOG00636
ParticipantsOG00736
Title
Measurements
OG000-2.4(-12.2 to 7.4)
OG001-2.9(-12.5 to 6.8)
OG002-16.2(-26.2 to -6.2)
OG003
At Week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00233
ParticipantsOG00333
At Week 3
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG00334
At Week 4
ParticipantsOG00030
ParticipantsOG00128
ParticipantsOG00233
ParticipantsOG00332
At Week 6
ParticipantsOG00029
ParticipantsOG00128
ParticipantsOG00231
ParticipantsOG00332
At Follow-up visit
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00232
ParticipantsOG00331
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
At Week 1: Mixed Model Repeated Measure (MMRM) contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.4781
LS Mean difference
-0.5
Standard Error of the Mean
8.33
2-Sided
90
-14.2
13.3
Superiority
OG000
OG002
At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0522
LS Mean difference
-13.8
Standard Error of the Mean
8.47
2-Sided
90
-27.8
0.2
Superiority
OG000
OG003
At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0187
LS Mean difference
-17.5
Standard Error of the Mean
8.37
2-Sided
90
-31.4
-3.7
Superiority
OG000
OG004
At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0080
LS Mean difference
-20.6
Standard Error of the Mean
8.45
2-Sided
90
-34.5
-6.6
Superiority
OG005
OG006
At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0401
LS Mean difference
-25.0
Standard Error of the Mean
14.17
2-Sided
90
-48.6
-1.5
Superiority
OG005
OG007
At Week 1: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0379
LS Mean difference
-25.5
Standard Error of the Mean
14.25
2-Sided
90
-49.2
-1.9
Superiority
OG000
OG001
At Week 2: MMRM contained fixed factors of treatment, visit(Weeks 1, 2, 3, 4, 6 and follow up), treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.7678
LS Mean difference
8.1
Standard Error of the Mean
11.01
2-Sided
90
-10.1
26.3
Superiority
OG000
OG002
At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0193
LS Mean difference
-22.8
Standard Error of the Mean
10.94
2-Sided
90
-40.9
-4.7
Superiority
OG000
OG003
At Week 2:MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0052
LS Mean difference
-28.3
Standard Error of the Mean
10.95
2-Sided
90
-46.5
-10.2
Superiority
OG000
OG004
At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0164
LS Mean difference
-23.7
Standard Error of the Mean
11.03
2-Sided
90
-42.0
-5.5
Superiority
OG005
OG006
At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0008
LS Mean difference
-31.7
Standard Error of the Mean
9.72
2-Sided
90
-47.8
-15.6
Superiority
OG005
OG007
At Week 2: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
<0.0001
LS Mean difference
-40.6
Standard Error of the Mean
9.86
2-Sided
90
-57.0
-24.3
Superiority
OG000
OG001
At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.6269
LS Mean difference
3.9
Standard Error of the Mean
12.09
2-Sided
90
-16.1
23.9
Superiority
OG000
OG002
At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0027
LS Mean difference
-33.5
Standard Error of the Mean
11.87
2-Sided
90
-53.1
-13.8
Superiority
OG000
OG003
At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0007
LS Mean difference
-38.8
Standard Error of the Mean
11.89
2-Sided
90
-58.5
-19.2
Superiority
OG000
OG004
At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0041
LS Mean difference
-32.1
Standard Error of the Mean
12.00
2-Sided
90
-51.9
-12.3
Superiority
OG005
OG006
At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.1054
LS Mean difference
-14.6
Standard Error of the Mean
11.61
2-Sided
90
-33.9
4.6
Superiority
OG005
OG007
At Week 3: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0542
LS Mean difference
-18.8
Standard Error of the Mean
11.62
2-Sided
90
-38.1
0.5
Superiority
OG000
OG001
At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.6847
LS Mean difference
5.8
Standard Error of the Mean
12.12
2-Sided
90
-14.2
25.9
Superiority
OG000
OG002
At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0062
LS Mean difference
-29.9
Standard Error of the Mean
11.82
2-Sided
90
-49.4
-10.3
Superiority
OG000
OG003
At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0040
LS Mean difference
-32.0
Standard Error of the Mean
11.89
2-Sided
90
-51.6
-12.3
Superiority
OG000
OG004
At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0054
LS Mean difference
-30.8
Standard Error of the Mean
11.97
2-Sided
90
-50.6
-11.0
Superiority
OG005
OG006
At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.1076
LS Mean difference
-11.7
Standard Error of the Mean
9.35
2-Sided
90
-27.2
3.9
Superiority
OG005
OG007
At Week 4: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0082
LS Mean difference
-23.0
Standard Error of the Mean
9.42
2-Sided
90
-38.6
-7.3
Superiority
OG000
OG001
At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.1051
LS Mean difference
-17.8
Standard Error of the Mean
14.14
2-Sided
90
-41.2
5.6
Superiority
OG000
OG002
At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0034
LS Mean difference
-37.8
Standard Error of the Mean
13.80
2-Sided
90
-60.6
-15.0
Superiority
OG000
OG003
At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0014
LS Mean difference
-41.9
Standard Error of the Mean
13.83
2-Sided
90
-64.8
-19.0
Superiority
OG000
OG004
At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0030
LS Mean difference
-38.6
Standard Error of the Mean
13.90
2-Sided
90
-61.6
-15.6
Superiority
OG005
OG006
At Week 6: MMRM contained fixed factors of treatment, visit(Weeks 1, 2, 3, 4, 6 and follow up), treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0289
LS Mean difference
-17.7
Standard Error of the Mean
9.22
2-Sided
90
-33.0
-2.4
Superiority
OG005
OG007
At Week 6: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0002
LS Mean difference
-33.8
Standard Error of the Mean
9.27
2-Sided
90
-49.2
-18.4
Superiority
OG000
OG001
At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.4739
LS Mean difference
-0.9
Standard Error of the Mean
13.88
2-Sided
90
-23.9
22.0
Superiority
OG000
OG002
At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0789
LS Mean difference
-19.1
Standard Error of the Mean
13.43
2-Sided
90
-41.3
3.2
Superiority
OG000
OG003
At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.1611
LS Mean difference
-13.4
Standard Error of the Mean
13.50
2-Sided
90
-35.7
8.9
Superiority
OG000
OG004
At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.0124
LS Mean Difference
-31.6
Standard Error of the Mean
13.94
2-Sided
90
-54.7
-8.5
Superiority
OG005
OG006
At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.3828
LS Mean difference
-5.3
Standard Error of the Mean
17.68
2-Sided
90
-34.7
24.1
Superiority
OG005
OG007
At follow-up visit: MMRM contained fixed factors of treatment, visit, treatment-by-visit interaction and baseline value.
Mixed Model Repeated Measure
0.5383
LS Mean difference
1.7
Standard Error of the Mean
17.80
2-Sided
90
-27.9
31.3
Superiority
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00037
OG00137
OG00236
OG00337
OG00436
OG00536
OG00636
OG00737
Title
Denominators
Categories
At Week 1
Title
Measurements
OG0005.4(1.4 to 15.5)
OG0010.0(0.0 to 7.3)
OG00219.4(10.7 to 32.8)
OG0035.4(1.4 to 15.5)
OG00416.7(7.5 to 30.2)
OG0050.0(0.0 to 7.5)
OG00613.9(6.9 to 25.4)
OG00721.6(11.2 to 34.3)
At Week 2
Title
Measurements
OG0008.1(3.0 to 18.5)
OG00110.8(4.8 to 22.2)
OG00227.8(15.9 to 40.9)
OG003
At Week 3
Title
Measurements
OG0005.4(1.4 to 15.5)
OG00116.2(7.3 to 29.3)
OG00236.1(22.9 to 50.0)
OG003
At Week 4
Title
Measurements
OG00024.3(14.5 to 37.0)
OG00121.6(11.2 to 34.3)
OG00238.9(25.4 to 53.0)
OG003
At Week 6
Title
Measurements
OG00035.1(22.2 to 49.3)
OG00132.4(20.6 to 46.4)
OG00252.8(38.0 to 67.2)
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
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.8964
Risk Difference (RD)
-5.4
2-Sided
90
-16.1
2.0
Superiority
OG000
OG002
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0391
Risk Difference (RD)
14.0
2-Sided
90
1.0
28.2
Superiority
OG000
OG003
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
1.0000
Risk Difference (RD)
0.0
2-Sided
90
-10.8
10.8
Superiority
OG000
OG004
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0708
Risk Difference (RD)
11.3
2-Sided
90
-1.4
25.0
Superiority
OG005
OG006
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0122
Risk Difference (RD)
13.9
2-Sided
90
4.7
27.0
Superiority
OG005
OG007
At Week 1: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0016
Risk Difference (RD)
21.6
2-Sided
90
11.0
35.6
Superiority
OG000
OG001
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.3950
Risk Difference (RD)
2.7
2-Sided
90
-9.8
16.1
Superiority
OG000
OG002
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0173
Risk Difference (RD)
19.7
2-Sided
90
4.2
35.6
Superiority
OG000
OG003
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0327
Risk Difference (RD)
16.2
2-Sided
90
1.4
31.0
Superiority
OG000
OG004
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0011
Risk Difference (RD)
30.8
2-Sided
90
13.2
46.6
Superiority
OG005
OG006
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1348
Risk Difference (RD)
11.1
2-Sided
90
-5.0
27.2
Superiority
OG005
OG007
At Week 2: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0328
Risk Difference (RD)
18.5
2-Sided
90
1.5
34.8
Superiority
OG000
OG001
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0769
Risk Difference (RD)
10.8
2-Sided
90
-1.8
24.4
Superiority
OG000
OG002
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0005
Risk Difference (RD)
30.7
2-Sided
90
13.2
46.0
Superiority
OG000
OG003
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
<0.0001
Risk Difference (RD)
37.8
2-Sided
90
22.1
53.1
Superiority
OG000
OG004
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0001
Risk Difference (RD)
36.3
2-Sided
90
19.7
51.8
Superiority
OG005
OG006
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
1.0000
Risk Difference (RD)
0.0
2-Sided
90
-16.5
16.5
Superiority
OG005
OG007
At Week 3: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0173
Risk Difference (RD)
23.8
2-Sided
90
4.5
41.5
Superiority
OG000
OG001
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.5663
Risk Difference (RD)
-2.7
2-Sided
90
-19.9
14.2
Superiority
OG000
OG002
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1243
Risk Difference (RD)
14.6
2-Sided
90
-3.8
32.6
Superiority
OG000
OG003
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0460
Risk Difference (RD)
18.9
2-Sided
90
-0.5
36.6
Superiority
OG000
OG004
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0130
Risk Difference (RD)
25.7
2-Sided
90
4.8
43.3
Superiority
OG005
OG006
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1194
Risk Difference (RD)
13.9
2-Sided
90
-4.2
31.4
Superiority
OG005
OG007
At Week 4: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0097
Risk Difference (RD)
26.4
2-Sided
90
6.5
44.4
Superiority
OG000
OG001
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.5556
Risk Difference (RD)
-2.7
2-Sided
90
-21.0
16.1
Superiority
OG000
OG002
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0761
Risk Difference (RD)
17.6
2-Sided
90
-2.5
36.5
Superiority
OG000
OG003
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0583
Risk Difference (RD)
18.9
2-Sided
90
-0.8
37.6
Superiority
OG000
OG004
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.1245
Risk Difference (RD)
14.9
2-Sided
90
-5.0
33.7
Superiority
OG005
OG006
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0382
Risk Difference (RD)
19.4
2-Sided
90
1.5
36.5
Superiority
OG005
OG007
At Week 6: Risk difference = difference in percentage of participants.
Chan and Zhang Exact Method
0.0011
Risk Difference (RD)
34.7
2-Sided
90
13.2
51.4
Superiority
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00037
OG00137
OG00236
OG00337
OG00436
OG00536
OG00636
OG00737
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00018
OG00117
OG00211
OG00312
OG00410
OG00517
OG0069
OG00714
SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00021
OG00120
OG00225
OG00318
OG00421
OG00519
OG00622
OG00722
Title
Denominators
Categories
Sitting DBP: Change >= 20 mm Hg increase
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG0029
ParticipantsOG00315
ParticipantsOG00412
ParticipantsOG0057
ParticipantsOG00612
ParticipantsOG00711
Title
Measurements
OG0000
OG0010
OG0021
OG003
Sitting DBP: Change >= 20mmHg decrease
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG0029
ParticipantsOG00315
Supine DBP: Value <50 mmHg
ParticipantsOG00021
ParticipantsOG00120
ParticipantsOG00225
ParticipantsOG00318
Supine DBP: Change >= 20mmHg increase
ParticipantsOG00021
ParticipantsOG00120
ParticipantsOG00225
ParticipantsOG00318
Supine DBP: Change >= 20mmHg decrease
ParticipantsOG00021
ParticipantsOG00120
ParticipantsOG00225
ParticipantsOG00318
Sitting SBP: <90mmHg
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG0029
ParticipantsOG00315
Sitting SBP: change >= 30mmHg increase
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG0029
ParticipantsOG00315
Sitting SBP: change >= 30mmHg decrease
ParticipantsOG00012
ParticipantsOG00113
ParticipantsOG0029
ParticipantsOG00315
Supine SBP: Change >= 30mmHg increase
ParticipantsOG00021
ParticipantsOG00120
ParticipantsOG00225
ParticipantsOG00318
Supine SBP: Change >= 30mmHg decrease
ParticipantsOG00021
ParticipantsOG00120
ParticipantsOG00225
ParticipantsOG00318
Supine SBP: Value <90mmHg
ParticipantsOG00021
ParticipantsOG00120
ParticipantsOG00225
ParticipantsOG00318
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00037
OG00135
OG00235
OG00337
OG00435
OG00536
OG00636
OG00736
Title
Denominators
Categories
Title
Measurements
OG00026
OG00122
OG00223
OG00322
OG00416
OG00521
OG00624
OG00724
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG0008
OG0016
OG0027
OG0039
OG00410
OG0056
OG0067
OG0077
Title
Denominators
Categories
PR interval : value >280 msec
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0070
PR interval : %change>=25/50%
Title
Measurements
OG0000
OG0011
OG0021
OG003
QRS interval: value >120 msec
Title
Measurements
OG0000
OG0010
OG0020
OG003
QRS interval: %Change>=50%
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF: 450 msec
Title
Measurements
OG0000
OG0010
OG0021
OG003
QTCF: 30<=Change<60
Title
Measurements
OG0000
OG0011
OG0021
OG003
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00032
OG00132
OG00232
OG00333
OG00432
OG00532
OG00634
OG00733
Title
Denominators
Categories
Change at week 1
ParticipantsOG00032
ParticipantsOG00132
ParticipantsOG00232
ParticipantsOG00330
ParticipantsOG00432
ParticipantsOG00532
ParticipantsOG00634
ParticipantsOG00733
Title
Measurements
OG0000.4± 25.99
OG001-7.4± 30.20
OG002-5.3± 16.99
OG003
Change at week 2
ParticipantsOG00032
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00333
Change at week 4
ParticipantsOG00026
ParticipantsOG00127
ParticipantsOG00230
ParticipantsOG00331
Change at week 6
ParticipantsOG00030
ParticipantsOG00126
ParticipantsOG00231
ParticipantsOG00331
Change at follow-up visit
ParticipantsOG00026
ParticipantsOG00128
ParticipantsOG00231
ParticipantsOG00330
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00034
OG00135
OG00233
OG00335
OG00434
OG00536
OG00636
OG00735
Title
Denominators
Categories
Protein: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00233
ParticipantsOG00335
ParticipantsOG00434
ParticipantsOG00534
ParticipantsOG00636
ParticipantsOG00735
Title
Measurements
OG000-0.01± 0.439
OG001-0.04± 0.294
OG002-0.14± 0.433
OG003
Protein:change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Protein: change at week 4
ParticipantsOG00029
ParticipantsOG00128
ParticipantsOG00233
ParticipantsOG00331
Protein: change at week 6
ParticipantsOG00030
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Protein: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG00332
Albumin:change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00233
ParticipantsOG00335
Albumin:change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Albumin: change at week 4
ParticipantsOG00029
ParticipantsOG00128
ParticipantsOG00233
ParticipantsOG00331
Albumin:change at week 6
ParticipantsOG00030
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Albumin: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG00332
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00034
OG00135
OG00233
OG00335
OG00434
OG00534
OG00636
OG00735
Title
Denominators
Categories
Urea nitrogen: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00233
ParticipantsOG00335
ParticipantsOG00434
ParticipantsOG00534
ParticipantsOG00636
ParticipantsOG00735
Title
Measurements
OG0000.9± 4.57
OG0010.6± 3.04
OG0020.1± 3.12
OG003
Urea nitrogen: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Urea nitrogen: change at week 4
ParticipantsOG00029
ParticipantsOG00128
ParticipantsOG00233
ParticipantsOG00331
Urea nitrogen: change at week 6
ParticipantsOG00030
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Urea nitrogen: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG00332
Urate:change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00233
ParticipantsOG00335
Urate: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Urate: change at week 4
ParticipantsOG00029
ParticipantsOG00128
ParticipantsOG00233
ParticipantsOG00331
Urate: change at week 6
ParticipantsOG00030
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Urate: change at follow- up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG00332
Calcium:change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00233
ParticipantsOG00335
Calcium: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Calcium: change at week 4
ParticipantsOG00029
ParticipantsOG00128
ParticipantsOG00233
ParticipantsOG00331
Calcium: change at week 6
ParticipantsOG00030
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Calcium: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG00332
Glucose:change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00233
ParticipantsOG00334
Glucose: change at week 2
ParticipantsOG00033
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Glucose: change at week 4
ParticipantsOG00029
ParticipantsOG00128
ParticipantsOG00233
ParticipantsOG00331
Glucose: change at week 6
ParticipantsOG00030
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Glucose: change at follow -up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG00332
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00034
OG00135
OG00233
OG00335
OG00434
OG00534
OG00636
OG00735
Title
Denominators
Categories
Sodium: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00233
ParticipantsOG00335
ParticipantsOG00434
ParticipantsOG00534
ParticipantsOG00636
ParticipantsOG00735
Title
Measurements
OG0000.1± 2.34
OG001-0.0± 1.77
OG002-0.7± 2.04
OG003
Sodium: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Sodium:change at week 4
ParticipantsOG00029
ParticipantsOG00128
ParticipantsOG00233
ParticipantsOG00331
Sodium:change at week 6
ParticipantsOG00030
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Sodium: change at follow up
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG00332
Potassium: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00233
ParticipantsOG00335
Potassium:change at week 2
ParticipantsOG00033
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Potassium: change at week 4
ParticipantsOG00029
ParticipantsOG00128
ParticipantsOG00233
ParticipantsOG00331
Potassium: change at week 6
ParticipantsOG00030
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Potassium: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG00332
Chloride: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00233
ParticipantsOG00335
Chloride: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Chloride: change at week 4
ParticipantsOG00029
ParticipantsOG00128
ParticipantsOG00233
ParticipantsOG00331
Chloride:change at week 6
ParticipantsOG00030
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Chloride: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG00332
Bicarbonate: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00233
ParticipantsOG00333
Bicarbonate: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Bicarbonate: change at week 4
ParticipantsOG00029
ParticipantsOG00128
ParticipantsOG00233
ParticipantsOG00331
Bicarbonate: change at week 6
ParticipantsOG00030
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Bicarbonate: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG00332
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00034
OG00137
OG00233
OG00334
OG00434
OG00533
OG00635
OG00734
Title
Denominators
Categories
Change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00232
ParticipantsOG00334
ParticipantsOG00434
ParticipantsOG00533
ParticipantsOG00635
ParticipantsOG00734
Title
Measurements
OG000-0.01± 0.790
OG001-0.22± 0.620
OG002-0.36± 0.775
OG003
Change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Change at week 4
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00331
Change at week 6
ParticipantsOG00029
ParticipantsOG00137
ParticipantsOG00231
ParticipantsOG00332
Change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00332
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00034
OG00135
OG00233
OG00334
OG00434
OG00533
OG00635
OG00734
Title
Denominators
Categories
Hematocrit: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00232
ParticipantsOG00334
ParticipantsOG00434
ParticipantsOG00533
ParticipantsOG00635
ParticipantsOG00733
Title
Measurements
OG0000.2± 2.51
OG001-0.8± 2.11
OG002-1.3± 2.61
OG003
Hematocrit: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Hematocrit: change at week 4
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00330
Hematocrit: change at week 6
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Hematocrit: change at follow-up (FU) visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00332
Reticulocytes/Erythrocytes change at week 1
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00229
ParticipantsOG00329
Reticulocytes/Erythrocytes: change at week 2
ParticipantsOG00031
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00329
Reticulocytes/Erythrocytes: change at week 4
ParticipantsOG00025
ParticipantsOG00124
ParticipantsOG00230
ParticipantsOG00327
Reticulocytes/Erythrocytes: change at week 6
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG00228
ParticipantsOG00328
Reticulocytes/Erythrocytes:change at FU visit
ParticipantsOG00027
ParticipantsOG00125
ParticipantsOG00227
ParticipantsOG00327
Lymphocytes/Leukocytes: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00232
ParticipantsOG00334
Lymphocytes/Leukocytes: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Lymphocytes/Leukocytes: change at week 4
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00331
Lymphocytes/Leukocytes: change at week 6
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Lymphocytes/Leukocytes: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG003
Neutrophils/Leukocytes: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00232
ParticipantsOG00334
Neutrophils/Leukocytes: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Neutrophils/Leukocytes: change at week 4
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00331
Neutrophils/Leukocytes: change at week 6
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Neutrophils/Leukocytes: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG003
Basophils/Leukocytes: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00232
ParticipantsOG00334
Basophils/Leukocytes: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Basophils/Leukocytes: change at week 4
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00331
Basophils/Leukocytes: change at week 6
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Basophils/Leukocytes: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG003
Eosinophils/Leukocytes: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00232
ParticipantsOG00334
Eosinophils/Leukocytes: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Eosinophils/Leukocytes: change at week 4
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00331
Eosinophils/Leukocytes: change at week 6
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Eosinophils/Leukocytes: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG003
Monocytes/Leukocytes: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00232
ParticipantsOG00334
Monocytes/Leukocytes: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Monocytes/Leukocytes : change at week 4
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00331
Monocytes/Leukocytes : change at week 6
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Monocytes/Leukocytes : change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG003
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00034
OG00135
OG00233
OG00334
OG00434
OG00533
OG00635
OG00734
Title
Denominators
Categories
Erythrocytes: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00232
ParticipantsOG00334
ParticipantsOG00434
ParticipantsOG00533
ParticipantsOG00635
ParticipantsOG00734
Title
Measurements
OG0000.03± 0.261
OG001-0.07± 0.232
OG002-0.12± 0.264
OG003
Erythrocytes: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Erythrocytes: change at week 4
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00331
Erythrocytes: change at week 6
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Erythrocytes: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00332
Reticulocytes: change at week 1
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00229
ParticipantsOG00329
Reticulocytes: change at week 2
ParticipantsOG00031
ParticipantsOG00130
ParticipantsOG00229
ParticipantsOG00329
Reticulocytes: change at week 4
ParticipantsOG00025
ParticipantsOG00124
ParticipantsOG00230
ParticipantsOG00327
Reticulocytes: change at week 6
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG00228
ParticipantsOG00328
Reticulocytes: change at follow-up visit
ParticipantsOG00027
ParticipantsOG00125
ParticipantsOG00227
ParticipantsOG00327
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00034
OG00135
OG00233
OG00334
OG00434
OG00533
OG00635
OG00734
Title
Denominators
Categories
Platelets: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00232
ParticipantsOG00334
ParticipantsOG00434
ParticipantsOG00533
ParticipantsOG00635
ParticipantsOG00734
Title
Measurements
OG0000.9± 60.03
OG0016.8± 34.08
OG002-3.3± 32.39
OG003
Platelets: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Platelets: change at week 4
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00331
Platelets: change at week 6
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Platelets: change at follow-up visit
ParticipantsOG00029
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00332
Leukocytes: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00232
ParticipantsOG00334
Leukocytes: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Leukocytes: change at week 4
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00331
Leukocytes: change at week 6
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Leukocytes: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00332
Lymphocytes: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00232
ParticipantsOG00334
Lymphocytes: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Lymphocytes: change at week 4
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00331
Lymphocytes: change at week 6
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Lymphocytes: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00332
Neutrophils: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00232
ParticipantsOG00334
Neutrophils: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Neutrophils: change at week 4
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00331
Neutrophils: change at week 6
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Neutrophils: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00332
Basophils: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00232
ParticipantsOG00334
Basophils: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Basophils: change at week 4
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00331
Basophils: change at week 6
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Basophils: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00332
Eosinophils: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00232
ParticipantsOG00334
Eosinophils: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Eosinophils: change at week 4
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00331
Eosinophils: change at week 6
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Eosinophils: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00332
Monocytes: change at week 1
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00232
ParticipantsOG00334
Monocytes: change at week 2
ParticipantsOG00034
ParticipantsOG00133
ParticipantsOG00232
ParticipantsOG00334
Monocytes: change at week 4
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00331
Monocytes: change at week 6
ParticipantsOG00029
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Monocytes: change at follow-up visit
ParticipantsOG00030
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00332
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00028
OG00127
OG00231
OG00332
OG00429
OG00524
OG00630
OG00732
Title
Denominators
Categories
HDL cholesterol
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
ParticipantsOG00429
ParticipantsOG00524
ParticipantsOG00630
ParticipantsOG00732
Title
Measurements
OG000-2.8± 6.65
OG0010.1± 5.34
OG002-1.3± 7.74
OG003
Triglycerides
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00331
Cholesterol
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
LDL Cholesterol
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00231
ParticipantsOG00332
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00028
OG00127
OG00231
OG00332
OG00429
OG00524
OG00630
OG00732
Title
Denominators
Categories
Title
Measurements
OG0000.0± 0.31
OG001-0.1± 0.48
OG002-0.2± 0.40
OG003-0.0± 0.32
OG004-0.3± 0.77
OG005-0.0± 0.35
OG0060.0± 0.46
OG007-0.0± 0.42
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00037
OG00137
OG00236
OG00337
OG00436
OG00536
OG00636
OG00737
Title
Denominators
Categories
Baseline
ParticipantsOG00037
ParticipantsOG00137
ParticipantsOG00236
ParticipantsOG00337
ParticipantsOG00436
ParticipantsOG00536
ParticipantsOG00636
ParticipantsOG00737
Title
Measurements
OG00066.8± 11.45
OG00166.9± 9.33
OG00268.4± 14.66
OG003
Change at week 2
ParticipantsOG00033
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00333
Change at week 6
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00332
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00037
OG00137
OG00236
OG00337
OG00436
OG00536
OG00636
OG00737
Title
Denominators
Categories
PR interval: baseline
ParticipantsOG00037
ParticipantsOG00137
ParticipantsOG00236
ParticipantsOG00337
ParticipantsOG00436
ParticipantsOG00536
ParticipantsOG00636
ParticipantsOG00737
Title
Measurements
OG000161.9± 23.30
OG001160.2± 24.01
OG002161.4± 27.59
OG003
PR interval: change at week 2
ParticipantsOG00033
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00333
PR interval: change at week 6
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00332
QRS interval: baseline
ParticipantsOG00037
ParticipantsOG00137
ParticipantsOG00236
ParticipantsOG00337
QRS interval: change at week 2
ParticipantsOG00033
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00333
QRS interval: change at week 6
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00332
QTCF interval: baseline
ParticipantsOG00037
ParticipantsOG00137
ParticipantsOG00236
ParticipantsOG00337
QTCF interval: change at week 2
ParticipantsOG00033
ParticipantsOG00131
ParticipantsOG00236
ParticipantsOG00333
QTCF interval: change at week 6
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00332
QT interval: baseline
ParticipantsOG00037
ParticipantsOG00137
ParticipantsOG00236
ParticipantsOG00337
QT interval: change at week 2
ParticipantsOG00033
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00333
QT interval: change at week 6
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00332
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00025
OG00126
OG00229
OG00322
OG00423
OG00526
OG00623
OG00725
Title
Denominators
Categories
Supine systolic BP: Baseline
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00322
ParticipantsOG00423
ParticipantsOG00526
ParticipantsOG00623
ParticipantsOG00725
Title
Measurements
OG000123.3± 12.01
OG001123.2± 12.35
OG002123.0± 13.89
OG003
Supine systolic BP: change at week 2
ParticipantsOG00021
ParticipantsOG00120
ParticipantsOG00225
ParticipantsOG00318
Supine systolic BP: change at week 6
ParticipantsOG00016
ParticipantsOG00115
ParticipantsOG00224
ParticipantsOG00317
Sitting systolic BP: Baseline
ParticipantsOG00015
ParticipantsOG00117
ParticipantsOG00217
ParticipantsOG00319
Sitting systolic BP: change at week 2
ParticipantsOG00012
ParticipantsOG00111
ParticipantsOG0028
ParticipantsOG00315
Sitting systolic BP: change at week 6
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG00315
Supine diastolic BP: Baseline
ParticipantsOG00025
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00322
Supine diastolic BP: change at week 2
ParticipantsOG00021
ParticipantsOG00120
ParticipantsOG00225
ParticipantsOG00318
Supine diastolic BP: change at week 6
ParticipantsOG00016
ParticipantsOG00115
ParticipantsOG00224
ParticipantsOG00317
Sitting diastolic BP: Baseline
ParticipantsOG00015
ParticipantsOG00117
ParticipantsOG00217
ParticipantsOG00319
Sitting diastolic BP: change at week 2
ParticipantsOG00012
ParticipantsOG00111
ParticipantsOG0028
ParticipantsOG00315
Sitting diastolic BP: change at week 6
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG0029
ParticipantsOG00315
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00037
OG00137
OG00236
OG00337
OG00436
OG00536
OG00636
OG00737
Title
Denominators
Categories
Baseline
ParticipantsOG00037
ParticipantsOG00137
ParticipantsOG00236
ParticipantsOG00337
ParticipantsOG00436
ParticipantsOG00536
ParticipantsOG00636
ParticipantsOG00737
Title
Measurements
OG00069.6± 12.58
OG00169.5± 9.82
OG00272.9± 14.30
OG003
Change at week 2
ParticipantsOG00033
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00333
Change at week 6
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00332
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
Units
Counts
Participants
OG00037
OG00137
OG00236
OG00337
OG00436
OG00536
OG00636
OG00737
Title
Denominators
Categories
Baseline
ParticipantsOG00037
ParticipantsOG00137
ParticipantsOG00236
ParticipantsOG00337
ParticipantsOG00436
ParticipantsOG00536
ParticipantsOG00636
ParticipantsOG00737
Title
Measurements
OG00036.5± 0.33
OG00136.5± 0.43
OG00236.6± 0.44
OG003
Change at week 2
ParticipantsOG00033
ParticipantsOG00131
ParticipantsOG00233
ParticipantsOG00333
Change at week 6
ParticipantsOG00028
ParticipantsOG00127
ParticipantsOG00233
ParticipantsOG00332
OG001
PF-06700841 0.1% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG002
PF-06700841 0.3% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG003
PF-06700841 1.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG004
PF-06700841 3.0% Cream QD
Participants or caregivers of participants, topically applied PF-06700841 3.0 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG005
Vehicle Cream Twice Daily (BID)
Participants or caregivers of participants, topically applied vehicle cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG006
PF-06700841 0.3% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.
OG007
PF-06700841 1.0% Cream BID
Participants or caregivers of participants, topically applied PF-06700841 1.0 % cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.