A Phase 2b Study of Baricitinib in Participants With Mode... | NCT01490632 | Trialant
NCT01490632
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Sep 27, 2019Actual
Enrollment
271Actual
Phase
Phase 2
Conditions
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Interventions
Placebo
Baricitinib
Countries
United States
Canada
Japan
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT01490632
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
14455
Secondary IDs
ID
Type
Description
Link
I4V-MC-JADP
Other Identifier
Eli Lilly and Company
Brief Title
A Phase 2b Study of Baricitinib in Participants With Moderate to Severe Psoriasis
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Phase 2b Study of Baricitinib in Patients With Moderate-to-Severe Plaque Psoriasis
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Sep 2019
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
Dec 2011
Primary Completion Date
Dec 2012Actual
Completion Date
Aug 2014Actual
First Submitted Date
Dec 9, 2011
First Submission Date that Met QC Criteria
Dec 9, 2011
First Posted Date
Dec 13, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 10, 2017
Results First Submitted that Met QC Criteria
Jun 19, 2017
Results First Posted Date
Jul 18, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 11, 2013
Certification/Extension First Submitted that Passed QC Review
Jan 25, 2013
Certification/Extension First Posted Date
Jan 29, 2013Estimated
Last Update Submitted Date
Sep 10, 2019
Last Update Posted Date
Sep 27, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Name
Class
Incyte Corporation
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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 is a dose-ranging study designed to investigate the efficacy and safety of Baricitinib in the treatment of participants with moderate to severe, chronic plaque psoriasis as assessed by the Psoriasis Area and Severity Index (PASI) score and routine safety assessments.
Detailed Description
Not provided
Conditions Module
Conditions
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Keywords
Moderate
Severe
Plaque
Chronic
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
271Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Part A: Placebo administered orally (PO) once daily (QD) for 12 weeks. Part B: Placebo participants stayed on placebo or re-randomized to baricitinib 8 milligram (mg) or 10 mg PO QD for 12 weeks. Part C: Baricitinib participants re-randomized to 4 mg or placebo PO QD for 16 weeks. Part D: Retreated with Part B efficacious dose.
Drug: Placebo
Baricitinib 2 mg
Experimental
Part A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or re-randomized to increased dose PO QD for 12 weeks. Part C: Participants re-randomized to half dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.
Drug: Baricitinib
Baricitinib 4 mg
Experimental
Part A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or re-randomized to increased dose PO QD for 12 weeks. Part C: Participants re-randomized to half dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.
Drug: Baricitinib
Baricitinib 8 mg
Experimental
Part A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or re-randomized to increased dose PO QD for 12 weeks. Part C: Participants re-randomized to half dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Administered orally
Placebo
Baricitinib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema (redness), and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])
The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
You must have active chronic plaque psoriasis for at least 6 months prior to entry into the study
You are a candidate for systemic therapy and/or phototherapy
You must have active plaque psoriasis covering at least 12% body surface area
You must have Psoriasis Area and Severity Index (PASI) score of at least 12
You must have Static Physician's Global Assessment (sPGA) score of at least 3
Exclusion Criteria:
You must not have received a biologic agent/monoclonal antibody within 8 weeks prior to entry into the study
You must not have prior treatment with an oral Janus kinase (JAK) inhibitor
You must not have received a systemic psoriasis (Ps) therapy within 4 weeks prior to entry into the study
You must not have received a phototherapy within 4 weeks prior to entry into the study
You must not have received a topical Ps therapy with psoralens within 4 weeks prior to entry into the study
You must not be pregnant or nursing
If female of childbearing potential or a male, and do not agree to use 2 forms of highly effective methods of birth control for at least 28 days following the last dose of investigational product
You must not have had symptomatic herpes zoster or herpes simplex infection within 12 weeks or have a history of disseminated/complicated herpes zoster
You must not have evidence of active infection, such as fever ≥38.0ºC (100.4ºF)
You must not have a history of active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
You must not be immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study
You must not have known history hypogammaglobulinemia
You must not have had a serious systemic or local infection within 12 weeks prior to entry into the study
You must not have been exposed to a live vaccine within 12 weeks prior to entry into the study, or expected to need/receive a live vaccine (including herpes zoster vaccination) during the course of the study
You must not have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB
You must not have a serious and/or unstable illness that, in the opinion of the investigator, poses an unacceptable risk for the your participation in the study
You must not have or have had a history of lymphoproliferative disease; or signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or active primary or recurrent malignant disease; or been in remission from clinically significant malignancy for less than 5 years
You must not have a history of chronic alcohol abuse or intravenous (IV) drug abuse within the last 2 years
You must not have donated blood of more than 500 mL within 4 weeks
You must not have received a topical Ps treatment within 2 weeks prior to entry into the study
Exceptions:
class 6 (mild, such as desonide) or class 7 (least potent, such as hydrocortisone) topical steroids used on the face, axilla, palms, soles, and/or genitalia
non-medicated shampoos (for example, that do not contain corticosteroids, coal tar, or vitamin D3 analogues)
emollients that do not contain alpha or beta hydroxyl acids
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bakersfield
California
93309
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Part A: Initial Treatment Period (Weeks 0 up to 12) Part B: Extension or Step-Up Period (Week 12 up to Week 24) Part C: Washout or Step-Down Period (Week 24 up to Week 40) Part D: (Re-Treatment Period up to 52 Weeks)
Recruitment Details
Participant Psoriasis Area and Severity Index (PASI) score at the conclusion of Part A stratified participants as either Responder (PASI ≥75), Partial Responder (PASI 50 - PASI 74), or Non-Responder (PASI <50).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: Placebo
Placebo administered orally (PO) once daily (QD) for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
FG001
Part A: Baricitinib 2 mg
Periods
Title
Milestones
Reasons Not Completed
Part A: Initial Treatment Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
4
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Drug: Baricitinib
Baricitinib 10 mg
Experimental
Part A: Baricitinib administered PO QD for initial 12 weeks. Part B: Depending on participant's response, participant was maintained on current dose, or discontinued from the study for 12 weeks. Part C: Participants re-randomized to 4mg dose or placebo PO QD for 16 weeks. Part D: Participants retreated with Part B efficacious dose for 52 weeks.
Drug: Baricitinib
Drug
Administered orally
Baricitinib 10 mg
Baricitinib 2 mg
Baricitinib 4 mg
Baricitinib 8 mg
LY3009104
INCB028050
Week 12
Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])
The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.
Week 24
Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])
The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.
Week 92
Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 12 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares Means (LS Means) were calculated using an analysis of covariance (ANCOVA) model on the last observation carried forward (LOCF) with treatment group as a fixed effect and baseline PASI score as a continuous covariate.
Baseline Part A, Week 12
Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 24 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis: Measure: Psoriasis Area and Severity Index [PASI])
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
Baseline Part A, Week 24
Change From Baseline in Part D in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 92 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
Baseline Part D, Week 92
Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Baseline Part A, Week 12
Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant.
Baseline Part A, Week 24
Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant.
Baseline Part D, Week 92
Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Baseline Part A, Week 12
Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Baseline Part A, Week 24
Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Baseline Part D, Week 92
Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score at Week 12
The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Baseline Part A, Week 12
Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24
The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation.
Baseline Part A, Week 24
Change From Baseline Part D in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 92
The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation.
Baseline Part D, Week 92
Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores
The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the "worst health you can imagine" and 100 mm indicated the "best health you can imagine". This information is used as a quantitative measure of health outcome. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
Baseline Part A, Week 12
Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores
The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the "worst health you can imagine" and 100 mm indicated the "best health you can imagine". This information is used as a quantitative measure of health outcome.
Baseline Part A, Week 24
Change From Baseline Part D in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores
The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the "worst health you can imagine" and 100 mm indicated the "best health you can imagine". This information is used as a quantitative measure of health outcome.
Baseline Part D, Week 92
Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C
Rebound was defined as worsening of psoriasis compared to baseline at Week 0 (for example, PASI score >125% of baseline value) or new pustular, erythrodermic, or more inflammatory psoriasis occurring within 3 months of stopping study drug.
Week 40
Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib
Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse
PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC Ï„,ss)
Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Santa Monica
California
90404
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Miami
Florida
33175
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Miramar
Florida
33027
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ocala
Florida
34471
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Alpharetta
Georgia
30022
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Arlington Heights
Illinois
60005
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Louisville
Kentucky
40202
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
East Windsor
New Jersey
08520
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Albuquerque
New Mexico
87104
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rochester
New York
14623
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Winston-Salem
North Carolina
27103
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Exton
Pennsylvania
19341
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Philadelphia
Pennsylvania
19103
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Austin
Texas
78705
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dallas
Texas
75246
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Salt Lake City
Utah
84132
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seattle
Washington
98101
United States
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Kelowna
British Columbia
V1Y 4X3
Canada
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Surrey
British Columbia
V3R 6A7
Canada
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Peterborough
Ontario
K9J 1Z2
Canada
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Richmond Hill
Ontario
L4B 1A5
Canada
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Waterloo
Ontario
N2J 1C4
Canada
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Sherbrooke
Quebec
J1H1Z1
Canada
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Chiba
292-8535
Japan
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Fukuoka
814-0180
Japan
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Ishikawa
923-8560
Japan
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Kanagawa
2308765
Japan
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Osaka
545-8586
Japan
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Saitama
350-0495
Japan
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Tochigi
329- 0498
Japan
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Tokyo
162-8543
Japan
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Toyama
9330871
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Carolina
00985
Puerto Rico
Baricitinib 2 milligram (mg) administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
FG002
Part A: Baricitinib 4 mg
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
FG003
Part A: Baricitinib 8 mg
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
FG004
Part A: Baricitinib 10 mg
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
FG005
Part B: Responder - Low Dose
Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
FG006
Part B: Responder - High Dose
Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
FG007
Part B: Partial- and Non-responder - Placebo to High Dose
Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
FG008
Part B: Partial-responder - Low Dose to Low Dose
Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
FG009
Part B: Partial- and Non-responder - Low Dose to High Dose
Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
FG010
Part B: Partial- and Non-responder - High Dose to High Dose
Baricitinib administered 8 mg or 10 mg PO QD.
FG011
Part B: Placebo Extension
Placebo PO QD maintained on placebo PO QD.
FG012
Part C: Responder - Low Dose to Placebo
Baricitinib 2 mg or 4 mg PO QD re-randomized to placebo PO QD.
FG013
Part C: Responder - Low Dose to ½ Low Dose
Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 1 mg or 2 mg PO QD.
FG014
Part C: Responder - High Dose to Placebo
Baricitinib administered 8 mg or 10 mg PO QD re-randomized to placebo PO QD.
FG015
Part C: Responder - High Dose to Low Dose
Baricitinib administered 8 mg PO QD re-randomized to baricitinib 4 mg PO QD. Baricitinib administered 10 mg PO QD re-randomized to baricitinib 4 mg PO QD.
FG016
Part D: Baricitinib 2 mg - Retreatment
Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
FG017
Part D: Baricitinib 4 mg - Retreatment
Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
FG018
Part D: Baricitinib 8 mg - Retreatment
Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
FG019
Part D: Baricitinib 10 mg - Retreatment
Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
FG00034 subjects
FG00132 subjects
FG00272 subjects
FG00364 subjects
FG00469 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
Received at Least One Dose of Study Drug
FG00034 subjects
FG00132 subjects
FG00272 subjects
FG00364 subjects
FG00469 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
COMPLETED
FG00027 subjects
FG00128 subjects
FG00267 subjects
FG00355 subjects
FG00452 subjectsIncludes participants who completed Part A, but discontinued per protocol using Part A PASI score.
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
NOT COMPLETED
FG0007 subjects
FG0014 subjects
FG0025 subjects
FG0039 subjects
FG00417 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0034 subjects
FG0044 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
Lack of Efficacy
FG0003 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Sponsor Decision
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
FG004
Discontinued at Week 12 per protocol
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part B: Extension or Step-Up Period
Type
Comment
Milestone Data
STARTED
FG0000 subjectsSee Recruitment Details for explanation of Part B participant assignment.
FG0010 subjectsSee Recruitment Details for explanation of Part B participant assignment.
FG0020 subjectsSee Recruitment Details for explanation of Part B participant assignment.
FG0030 subjectsSee Recruitment Details for explanation of Part B participant assignment.
FG0040 subjectsSee Recruitment Details for explanation of Part B participant assignment.
FG00529 subjectsPart A participants randomized to 2 mg or 4 mg with a PASI ≥75 remained on 2 mg or 4 mg.
FG00664 subjectsPart A participants randomized to 8 mg or 10 mg with a PASI ≥75 remained on 8 mg or 10 mg.
FG00719 subjectsPlacebo participants in Part A with a PASI \<75 were re-randomized to 8 mg or 10 mg.
FG00816 subjectsPart A participants randomized to 2 mg or 4 mg with a PASI ≥50 to \<75 remained on 2 mg or 4 mg.
FG00950 subjectsPart A participants randomized to 2 mg or 4 mg with a PASI \<50 were re-randomized to 8 mg or 10 mg.
FG01043 subjectsPart A 10 mg non-responders were discontinued from the study.
FG0118 subjectsPart A participants randomized to Placebo remained on Placebo.
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part C: Washout or Step-Down Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjectsOne participant completed Part B but discontinued without receiving a Part C treatment assignment.
FG0050 subjectsPart A participants randomized to 2 mg or 4 mg with a PASI ≥75 remained on 2 mg or 4 mg.
FG0060 subjectsPart A participants randomized to 8 mg or 10 mg with a PASI ≥75 remained on 8 mg or 10 mg.
FG0070 subjectsPlacebo participants in Part A with a PASI \<75 were re-randomized to 8 mg or 10 mg.
FG0080 subjectsPart A participants randomized to 2 mg or 4 mg with a PASI ≥50 to \<75 remained on 2 mg or 4 mg.
FG0090 subjectsPart A participants randomized to 2 mg or 4 mg with a PASI \<50 were re-randomized to 8 mg or 10 mg.
FG0100 subjectsPart A 10 mg non-responders were discontinued from the study.
FG0110 subjectsPart A participants randomized to Placebo remained on Placebo.
FG01215 subjectsResponders receiving 2 or 4 mg were re-randomized to receive placebo.
FG01316 subjectsResponders receiving 2 or 4 mg were re-randomized to receive half of the dose from Part B.
FG01455 subjectsResponders receiving 8 or 10 mg were re-randomized to receive placebo.
FG01555 subjectsResponders receiving 8 or 10 mg were re-randomized to receive 4 mg.
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part D: Re-Treatment Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjectsResponders receiving 2 or 4 mg were re-randomized to receive placebo.
FG0130 subjectsResponders receiving 2 or 4 mg were re-randomized to receive half of the dose from Part B.
FG0140 subjectsResponders receiving 8 or 10 mg were re-randomized to receive placebo.
FG0150 subjectsResponders receiving 8 or 10 mg were re-randomized to receive 4 mg.
FG0163 subjectsResponders who experienced a relapse or flare proceeded for retreatment with 2 mg.
FG01713 subjectsResponders who experienced a relapse or flare proceeded for retreatment with 4 mg.
FG01819 subjectsResponders who experienced a relapse or flare proceeded for retreatment with 8 mg.
FG01937 subjectsResponders who experienced a relapse or flare proceeded for retreatment with 10 mg.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: Placebo
Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
BG001
Part A: Baricitinib 2 mg
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
BG002
Part A: Baricitinib 4 mg
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
BG003
Part A: Baricitinib 8 mg
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
BG004
Part A: Baricitinib 10 mg
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00034
BG00132
BG00272
BG00364
BG00469
BG005271
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00046.70± 15.144
BG00147.81± 15.165
BG00247.21± 11.650
BG003
Sex/Gender, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG0019
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0016
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Japan
Title
Measurements
BG0004
BG0014
BG002
Duration of Psoriasis (Ps)
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00016.42± 14.297
BG00115.00± 9.951
BG002
Percent Body Surface Area (BSA) Affected by Psoriasis
Mean
Standard Deviation
Percent of BSA
Title
Denominators
Categories
Title
Measurements
BG00023.18± 11.890
BG00130.78± 20.523
BG002
Baseline Psoriasis Area and Severity Index (PASI) Score
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.
Mean
Standard Deviation
Units on a Scale
Title
Denominators
Categories
Title
Measurements
BG00019.06± 6.805
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving Psoriasis Area and Severity Index Score ≥75% (PASI 75) Improvement (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation (scaling), erythema (redness), and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease.
North American (NA) modified intent-to-treat (mITT) population: All NA randomized participants who received at least one dose of study drug. Non-responders and participants who discontinued study drug any time prior to time point of interest, or discontinued from study, were defined as non-responders for the non-responder imputation (NRI) analysis.
Posted
Number
Percent of Participants
Week 12
ID
Title
Description
OG000
Part A: Placebo
Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG001
Part A: Baricitinib 2 mg
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG002
Part A: Baricitinib 4 mg
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG003
Part A: Baricitinib 8 mg
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
OG004
Part A: Baricitinib 10 mg
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Units
Counts
Participants
OG00030
OG00128
OG00263
OG003
Title
Denominators
Categories
Title
Measurements
OG00016.7
OG00128.6
OG00228.6
OG003
Secondary
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])
The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.
All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.
Posted
Number
Percent of Participants
Week 12
ID
Title
Description
OG000
Part A: Placebo
Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG001
Part A: Baricitinib 2 mg
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Secondary
Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])
The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.
All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.
Posted
Number
Percent of Participants
Week 24
ID
Title
Description
OG000
Part B: Responder - Low Dose
Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
OG001
Part B: Responder - High Dose
Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
OG002
Part B: Partial- and Non-responder - Placebo to High Dose
Secondary
Percentage of Participants Achieving an sPGA of (0, 1) (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment [sPGA])
The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA (0,1) response was defined as a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline in sPGA score.
All randomized participants who received at least one dose of study drug. Non-Responders, as well as all participants who discontinue study treatment at any time prior to the time point of interest, were defined as Non-Responders for the NRI analysis.
Posted
Number
Percent of Participants
Week 92
ID
Title
Description
OG000
Part D: Baricitinib 2 mg - Retreatment
Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
OG001
Part D: Baricitinib 4 mg - Retreatment
Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
OG002
Part D: Baricitinib 8 mg - Retreatment
Secondary
Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 12 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. Least Squares Means (LS Means) were calculated using an analysis of covariance (ANCOVA) model on the last observation carried forward (LOCF) with treatment group as a fixed effect and baseline PASI score as a continuous covariate.
All randomized participants who received at least one dose of study drug. Missing values were imputed with the last observation carried forward (LOCF) method.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline Part A, Week 12
ID
Title
Description
OG000
Part A: Placebo
Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG001
Part A: Baricitinib 2 mg
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Secondary
Change From Baseline in Part A in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 24 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis: Measure: Psoriasis Area and Severity Index [PASI])
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
All randomized participants who received at least one dose of study drug and at least 1 post-baseline observation in Part A at or prior to week 24. Missing values were imputed with the last observation carried forward (LOCF) method.
Posted
Mean
Standard Deviation
Units on a Scale
Baseline Part A, Week 24
ID
Title
Description
OG000
Part B: Responder - Low Dose
Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
OG001
Part B: Responder - High Dose
Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
OG002
Part B: Partial- and Non-responder - Placebo to High Dose
Secondary
Change From Baseline in Part D in Mean Psoriasis Area and Severity Index (PASI) Total Score to Week 92 (Efficacy of Baricitinib in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index [PASI])
The PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
All randomized participants who received ≥1 dose of study drug and has 1 post-baseline observation at or prior to week 92. Missing values were imputed with the last observation carried forward (LOCF) method.
Posted
Mean
Standard Deviation
Units on a Scale
Baseline Part D, Week 92
ID
Title
Description
OG000
Part D: Baricitinib 2 mg - Retreatment
Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
OG001
Part D: Baricitinib 4 mg - Retreatment
Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
OG002
Part D: Baricitinib 8 mg - Retreatment
Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Secondary
Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 12
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant. Least Square (LS) Means in total DLQI score were calculated using Mixed Model Repeated Measures (MMRM) with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline Part A, Week 12
ID
Title
Description
OG000
Part A: Placebo
Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG001
Part A: Baricitinib 2 mg
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Secondary
Change From Baseline Part A in Dermatology Life Quality Index (DLQI) Total Score to Week 24
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant.
All randomized participants who received ≥1 dose of study drug in Part B and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Posted
Mean
Standard Deviation
Units on a Scale
Baseline Part A, Week 24
ID
Title
Description
OG000
Part B: Responder - Low Dose
Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
OG001
Part B: Responder - High Dose
Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
OG002
Part B: Partial- and Non-responder - Placebo to High Dose
Secondary
Change From Baseline Part D in Dermatology Life Quality Index (DLQI) Total Score to Week 92
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment), and a 5 point change from baseline is considered clinically relevant.
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline DLQI observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Posted
Mean
Standard Deviation
Units on a Scale
Baseline Part D, Week 92
ID
Title
Description
OG000
Part D: Baricitinib 2 mg - Retreatment
Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
OG001
Part D: Baricitinib 4 mg - Retreatment
Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
OG002
Part D: Baricitinib 8 mg - Retreatment
Secondary
Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score at Week 12
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline Part A, Week 12
ID
Title
Description
OG000
Part A: Placebo
Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG001
Part A: Baricitinib 2 mg
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks
OG002
Secondary
Change From Baseline Part A in Itch Numeric Rating Scale (Itch NRS) Score to Week 24
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Posted
Mean
Standard Deviation
Units on a Scale
Baseline Part A, Week 24
ID
Title
Description
OG000
Part B: Responder - Low Dose
Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
OG001
Part B: Responder - High Dose
Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
OG002
Part B: Partial- and Non-responder - Placebo to High Dose
Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
Secondary
Change From Baseline Part D in Itch Numeric Rating Scale (Itch NRS) Score to Week 92
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline Itch NRS observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Posted
Mean
Standard Deviation
Units on a Scale
Baseline Part D, Week 92
ID
Title
Description
OG000
Part D: Baricitinib 2 mg - Retreatment
Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
OG001
Part D: Baricitinib 4 mg - Retreatment
Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
OG002
Part D: Baricitinib 8 mg - Retreatment
Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Secondary
Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score at Week 12
The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline Part A, Week 12
ID
Title
Description
OG000
Part A: Placebo
Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG001
Part A: Baricitinib 2 mg
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Secondary
Change From Baseline Part A in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 24
The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation.
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. As observed values were used.
Posted
Mean
Standard Deviation
Units on a Scale
Baseline Part A, Week 24
ID
Title
Description
OG000
Part B: Responder - Low Dose
Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
OG001
Part B: Responder - High Dose
Secondary
Change From Baseline Part D in Quick Inventory of Depressive Symptomatology-Self Report 16 Items (QIDS-SR16) Total Score to Week 92
The QIDS-SR16 is a 16-item, self-report instrument intended to assess the existence and severity of symptoms of depression as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) (APA 1994). A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 to 3. The 16 items corresponding to 9 depression domains are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The domains assessed by the instrument include: (1) sad mood, (2) concentration, (3) self-criticism, (4) suicidal ideation, (5) interest, (6) energy/fatigue, (7) sleep disturbance (initial, middle, and late insomnia or hypersomnia), (8) decrease/increase in appetite/weight, and (9) psychomotor agitation/retardation.
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline QIDS-SR16 observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Posted
Mean
Standard Deviation
Units on a Scale
Baseline Part D, Week 92
ID
Title
Description
OG000
Part D: Baricitinib 2 mg - Retreatment
Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
OG001
Part D: Baricitinib 4 mg - Retreatment
Secondary
Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores
The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the "worst health you can imagine" and 100 mm indicated the "best health you can imagine". This information is used as a quantitative measure of health outcome. LS Means were calculated using MMRM with baseline score as covariate, treatment, pooled center, visit and treatment-by-visit interaction as fixed effects.
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. As observed values were used.
Posted
Least Squares Mean
Standard Error
Millimeter (mm)
Baseline Part A, Week 12
ID
Title
Description
OG000
Part A: Placebo
Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG001
Part A: Baricitinib 2 mg
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
Secondary
Change From Baseline Part A in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores
The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the "worst health you can imagine" and 100 mm indicated the "best health you can imagine". This information is used as a quantitative measure of health outcome.
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. As observed values were used.
Posted
Mean
Standard Deviation
mm
Baseline Part A, Week 24
ID
Title
Description
OG000
Part B: Responder - Low Dose
Baricitinib administered 2 mg or 4 mg PO QD maintained at baricitinib 2 mg or 4 mg PO QD, respectively.
OG001
Part B: Responder - High Dose
Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
OG002
Part B: Partial- and Non-responder - Placebo to High Dose
Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
Secondary
Change From Baseline Part D in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Scores
The EQ-5D-5L is a standardized measure of health status of the participant. One of two portions of the EQ-5D-5L was used in which a self-perceived health score is assessed using a visual analogue scale (VAS) that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the "worst health you can imagine" and 100 mm indicated the "best health you can imagine". This information is used as a quantitative measure of health outcome.
All randomized participants who received ≥1 dose of study drug in Part A and had ≥1 evaluable post-baseline EQ-5D-5L observation. Missing values were imputed with the last observation carried forward (LOCF) method.
Posted
Mean
Standard Deviation
mm
Baseline Part D, Week 92
ID
Title
Description
OG000
Part D: Baricitinib 2 mg - Retreatment
Baricitinib 2 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
OG001
Part D: Baricitinib 4 mg - Retreatment
Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
OG002
Part D: Baricitinib 8 mg - Retreatment
Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Secondary
Percentage of Participants Experiencing Rebound Upon Discontinuation of Study Drug in Part C
Rebound was defined as worsening of psoriasis compared to baseline at Week 0 (for example, PASI score >125% of baseline value) or new pustular, erythrodermic, or more inflammatory psoriasis occurring within 3 months of stopping study drug.
All randomized participants who received ≥1 dose of study drug in Part A and participated in Part C.
Posted
Number
Percentage of Participants
Week 40
ID
Title
Description
OG000
Part C: Responder - Low Dose to Placebo
Baricitinib 2 mg or 4 mg PO QD re-randomized to placebo PO QD.
OG001
Part C: Responder - Low Dose to ½ Low Dose
Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 1 mg or 2 mg PO QD.
OG002
Part C: Responder - High Dose to Placebo
Baricitinib administered 8 mg or 10 mg PO QD re-randomized to placebo PO QD.
OG003
Part C: Responder - High Dose to Low Dose
Secondary
Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib
All randomized participants who received ≥1 dose of study drug in Part A, had evaluable PK, and participated in Part C. Some participants received 4mg or 8 mg and increased to 8mg or 10 mg, depending on the response at week 12. Those participants are treated as separate participants in each dose group.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanomole (nM)
Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse
ID
Title
Description
OG000
Baricitinib 2 mg
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG001
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG002
Baricitinib 8 mg
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks
Secondary
PK: Area Under the Concentration-Time Curve Versus Time During One Dosing Interval at Steady State (AUC Ï„,ss)
All randomized participants who received ≥1 dose of study drug in Part A, had evaluable PK, and participated in Part A, B or C. Some participants received 4mg or 8 mg and increased to 8mg or 10 mg, depending on the response at week 12. Those participants are treated as separate participants in each dose group.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanomole*hour (nM*h)
Day 1:15 minutes(m) to 30m and 1hour(h) to 3h Postdose; Week 1:Predose; Week 4:Predose; Week 8:Predose; 15m to 30m and 1h to 3h Postdose, Week 12:Predose; Weeks 14 and 20; Week 24:Predose; Week 28; Week 40. If applicable: Weeks 4, 24, and 52 Post-Relapse
ID
Title
Description
OG000
Baricitinib 2 mg
Baricitinib 2 milligram (mg) administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG001
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG002
Baricitinib 8 mg
Time Frame
Not provided
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
Part A: Placebo
Placebo administered orally once daily for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
1
34
11
34
EG001
Part A: Baricitinib 2 mg
Baricitinib 2 milligram administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
1
32
9
32
EG002
Part A: Baricitinib 4 mg
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
1
72
12
72
EG003
Part A: Baricitinib 8 mg
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
1
64
21
64
EG004
Part A: Baricitinib 10 mg
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
1
69
23
69
EG005
Part B: Placebo
Placebo PO QD maintained on placebo PO QD.
0
8
4
8
EG006
Part B: Low Dose
All participants in the following groups (as described in the Participant Flow):
Responder Low Dose
Partial Responder Low Dose to Low Dose groups.
0
45
13
45
EG007
Part B: High Dose
All participants in the following groups (as described in the Participant Flow):
Responder High Dose
Partial and Non-responder Placebo to High Dose
Partial and Non-responder Low Dose to High Dose
Partial and Non-responder High Dose to High Dose
2
176
41
176
EG008
Part C: Placebo
All placebo participant groups after study drug re-randomized.
1
70
11
70
EG009
Part C: Baricitinib
All baricitinib participant groups after study drug re-randomized to various doses.
1
71
16
71
EG010
Part D: All Baricitinib Doses
All participant dosages following baricitinib retreatment with Part B efficacious dose for 52 weeks.
1
72
37
72
EG011
Follow-up: Always Placebo
Participants in follow-up with exposure to placebo only during the study. No placebo received during follow-up.
0
8
0
8
EG012
Follow-up: Ever Used Baricitinib
Participants in follow-up with exposure to any dose of baricitinib during study. No baricitinib received during follow-up.
0
185
8
185
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG0030 events0 affected64 at risk
EG0040 events0 affected69 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected176 at risk
EG0080 events0 affected70 at risk
EG0090 events0 affected71 at risk
EG0101 events1 affected72 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected185 at risk
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected72 at risk
EG003
Ovarian adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Diabetic foot
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphopenia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG0034 events3 affected64 at risk
EG0040 events0 affected69 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected176 at risk
EG0081 events1 affected70 at risk
EG0090 events0 affected71 at risk
EG0102 events2 affected72 at risk
EG0110 events0 affected8 at risk
EG0120 events0 affected185 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Fatigue
General disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0012 events2 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Influenza
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0007 events4 affected34 at risk
EG0011 events1 affected32 at risk
EG0022 events2 affected72 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0011 events1 affected32 at risk
EG0021 events1 affected72 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0011 events1 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected34 at risk
EG0011 events1 affected32 at risk
EG0023 events3 affected72 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0012 events2 affected32 at risk
EG0021 events1 affected72 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected72 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0011 events1 affected32 at risk
EG0022 events2 affected72 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Headache
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected34 at risk
EG0010 events0 affected32 at risk
EG0023 events3 affected72 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Menopausal symptoms
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0021 events1 affected72 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Hysterectomy
Surgical and medical procedures
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Salpingo-oophorectomy bilateral
Surgical and medical procedures
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected34 at risk
EG0010 events0 affected32 at risk
EG0020 events0 affected72 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ID
Term
D011565
Psoriasis
D012871
Skin Diseases
D017444
Skin Diseases, Papulosquamous
D008224
Lymphoma, Follicular
D058225
Plaque, Amyloid
D000092122
Bronchiolitis Obliterans Syndrome
Ancestor Terms
ID
Term
D017437
Skin and Connective Tissue Diseases
D008228
Lymphoma, Non-Hodgkin
D008223
Lymphoma
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
D006425
Hemic and Lymphatic Diseases
D007160
Immunoproliferative Disorders
D007154
Immune System Diseases
D020763
Pathological Conditions, Anatomical
D013568
Pathological Conditions, Signs and Symptoms
D000092124
Organizing Pneumonia
D001989
Bronchiolitis Obliterans
D001988
Bronchiolitis
D001991
Bronchitis
D001982
Bronchial Diseases
D012140
Respiratory Tract Diseases
D008173
Lung Diseases, Obstructive
D008171
Lung Diseases
D006086
Graft vs Host Disease
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000596027
baricitinib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
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FG0150 subjects
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FG0190 subjects
2 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
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FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
2 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
9 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
0 subjects
FG00525 subjects
FG00651 subjects
FG00713 subjects
FG0086 subjects
FG00925 subjects
FG01022 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
0 subjects
FG0054 subjects
FG00613 subjects
FG0076 subjects
FG00810 subjects
FG00925 subjects
FG01021 subjects
FG0118 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
0 subjects
FG0040 subjects
FG0052 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0092 subjects
FG0103 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
FG0093 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0101 subjects
FG0112 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
Completed Part B and Not Moving to PartC
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0066 subjects
FG0076 subjects
FG0088 subjects
FG00919 subjects
FG01016 subjects
FG0115 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG01210 subjects
FG0136 subjects
FG01437 subjects
FG01518 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0125 subjects
FG01310 subjects
FG01418 subjects
FG01537 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0142 subjects
FG0152 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0142 subjects
FG0151 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
Did Not Qualify for Part D Per Protocol
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0125 subjects
FG0139 subjects
FG01414 subjects
FG01534 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0163 subjects
FG0178 subjects
FG01812 subjects
FG01930 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0175 subjects
FG0187 subjects
FG0197 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0171 subjects
FG0181 subjects
FG0193 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0181 subjects
FG0190 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0173 subjects
FG0181 subjects
FG0192 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0181 subjects
FG0190 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0181 subjects
FG0191 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0181 subjects
FG0190 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0171 subjects
FG0181 subjects
FG0191 subjects
47.37
± 15.829
BG00447.43± 10.425
BG00547.31± 13.268
18
BG00318
BG00418
BG00574
Male
BG00023
BG00123
BG00254
BG00346
BG00451
BG005197
11
BG00312
BG00410
BG00543
Not Hispanic or Latino
BG00030
BG00126
BG00261
BG00352
BG00459
BG005228
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
0
BG0031
BG0040
BG0051
Asian
BG0007
BG0016
BG00212
BG0039
BG00411
BG00545
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
Black or African American
BG0001
BG0010
BG0021
BG0031
BG0044
BG0057
White
BG00026
BG00126
BG00258
BG00352
BG00453
BG005215
More than one race
BG0000
BG0010
BG0020
BG0031
BG0041
BG0052
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0030
BG0040
BG0051
9
BG0038
BG0048
BG00533
North America
Title
Measurements
BG00030
BG00128
BG00263
BG00356
BG00461
BG005238
19.90
± 12.766
BG00316.56± 11.948
BG00416.60± 10.653
BG00517.26± 11.995
28.61
± 18.797
BG00328.23± 15.726
BG00424.45± 12.079
BG00527.04± 16.101
21.36
± 11.056
BG00220.58± 9.438
BG00320.24± 7.827
BG00419.01± 6.177
BG00520.00± 8.228
56
OG00461
42.9
OG00454.1
OG002
Part A: Baricitinib 4 mg
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG003
Part A: Baricitinib 8 mg
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
OG004
Part A: Baricitinib 10 mg
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Units
Counts
Participants
OG00034
OG00132
OG00272
OG00364
OG00469
Title
Denominators
Categories
Title
Measurements
OG00014.7
OG00115.6
OG00225.0
OG00329.7
OG00434.8
Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
OG003
Part B: Partial-responder - Low Dose to Low Dose
Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
OG004
Part B: Partial- and Non-responder - Low Dose to High Dose
Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
OG005
Part B: Partial- and Non-responder - High Dose to High Dose
Baricitinib administered 8 mg or 10 mg PO QD.
OG006
Part B: Placebo Extension
Placebo PO QD maintained on placebo PO QD.
Units
Counts
Participants
OG00029
OG00164
OG00219
OG00316
OG00450
OG00543
OG0068
Title
Denominators
Categories
Title
Measurements
OG00055.2
OG00164.1
OG00247.4
OG00337.5
OG00424.0
OG00527.9
OG00650.0
Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
OG003
Part D: Baricitinib 10 mg - Retreatment
Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Units
Counts
Participants
OG0003
OG00113
OG00219
OG00337
Title
Denominators
Categories
Title
Measurements
OG00033.3
OG00123.1
OG00221.1
OG00327.0
OG002
Part A: Baricitinib 4 mg
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG003
Part A: Baricitinib 8 mg
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks
OG004
Part A: Baricitinib 10 mg
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Units
Counts
Participants
OG00034
OG00132
OG00272
OG00364
OG00469
Title
Denominators
Categories
Title
Measurements
OG0005.14± 1.370
OG0019.40± 1.413
OG0029.46± 0.941
OG00311.52± 0.997
OG00413.93± 0.962
Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
OG003
Part B: Partial-responder - Low Dose to Low Dose
Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
OG004
Part B: Partial- and Non-responder - Low Dose to High Dose
Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
OG005
Part B: Partial- and Non-responder - High Dose to High Dose
Baricitinib administered 8 mg or 10 mg PO QD.
OG006
Part B: Placebo Extension
Placebo PO QD maintained on placebo PO QD.
Units
Counts
Participants
OG00029
OG00164
OG00219
OG00316
OG00450
OG00543
OG0068
Title
Denominators
Categories
Title
Measurements
OG00015.62± 5.480
OG00116.69± 7.399
OG00212.94± 6.711
OG00312.23± 7.510
OG00414.55± 10.493
OG00513.67± 9.966
OG00613.43± 5.599
OG003
Part D: Baricitinib 10 mg - Retreatment
Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Units
Counts
Participants
OG0003
OG00113
OG00219
OG00337
Title
Denominators
Categories
Title
Measurements
OG0006.33± 2.836
OG0013.25± 4.447
OG0025.84± 5.544
OG0036.98± 6.456
OG002
Part A: Baricitinib 4 mg
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG003
Part A: Baricitinib 8 mg
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
OG004
Part A: Baricitinib 10 mg
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Units
Counts
Participants
OG00034
OG00132
OG00272
OG00363
OG00468
Title
Denominators
Categories
Title
Measurements
OG000-1.7± 0.98
OG001-3.4± 1.00
OG002-4.6± 0.67
OG003-4.0± 0.71
OG004-5.1± 0.69
Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
OG003
Part B: Partial-responder - Low Dose to Low Dose
Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
OG004
Part B: Partial- and Non-responder - Low Dose to High Dose
Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
OG005
Part B: Partial- and Non-responder - High Dose to High Dose
Baricitinib administered 8 mg or 10 mg PO QD.
OG006
Part B: Placebo Extension
Placebo PO QD maintained on placebo PO QD.
Units
Counts
Participants
OG00029
OG00164
OG00219
OG00316
OG00450
OG00542
OG0066
Title
Denominators
Categories
Title
Measurements
OG000-6.9± 7.53
OG001-7.0± 8.18
OG002-3.8± 6.27
OG003-1.5± 5.92
OG004-7.8± 6.89
OG005-4.5± 8.99
OG006-3.5± 11.76
Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
OG003
Part D: Baricitinib 10 mg - Retreatment
Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Units
Counts
Participants
OG0003
OG00113
OG00218
OG00337
Title
Denominators
Categories
Title
Measurements
OG000-3.3± 4.93
OG001-0.5± 3.62
OG002-2.1± 7.40
OG003-5.0± 6.31
Part A: Baricitinib 4 mg
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG003
Part A: Baricitinib 8 mg
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
OG004
Part A: Baricitinib 10 mg
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Units
Counts
Participants
OG00034
OG00132
OG00272
OG00364
OG00469
Title
Denominators
Categories
Title
Measurements
OG000-1.1± 0.48
OG001-2.8± 0.49
OG002-3.3± 0.33
OG003-3.8± 0.35
OG004-4.7± 0.34
OG003
Part B: Partial-responder - Low Dose to Low Dose
Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
OG004
Part B: Partial- and Non-responder - Low Dose to High Dose
Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
OG005
Part B: Partial- and Non-responder - High Dose to High Dose
Baricitinib administered 8 mg or 10 mg PO QD.
OG006
Part B: Placebo Extension
Placebo PO QD maintained on placebo PO QD.
Units
Counts
Participants
OG00029
OG00164
OG00219
OG00316
OG00449
OG00543
OG0068
Title
Denominators
Categories
Title
Measurements
OG000-4.7± 3.52
OG001-5.6± 2.96
OG002-5.4± 3.83
OG003-3.4± 3.69
OG004-4.1± 3.33
OG005-3.5± 3.03
OG006-2.5± 4.11
OG003
Part D: Baricitinib 10 mg - Retreatment
Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Units
Counts
Participants
OG0003
OG00113
OG00218
OG00337
Title
Denominators
Categories
Title
Measurements
OG000-2.3± 0.58
OG001-2.5± 3.23
OG002-2.7± 2.91
OG003-3.1± 3.38
OG002
Part A: Baricitinib 4 mg
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG003
Part A: Baricitinib 8 mg
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
OG004
Part A: Baricitinib 10 mg
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Units
Counts
Participants
OG00031
OG00130
OG00267
OG00363
OG00464
Title
Denominators
Categories
Title
Measurements
OG000-0.9± 0.57
OG001-1.0± 0.58
OG002-1.0± 0.39
OG003-0.7± 0.40
OG004-0.9± 0.40
Baricitinib administered 8 mg or 10 mg PO QD maintained at baricitinib 8 mg or 10 mg PO QD, respectively.
OG002
Part B: Partial- and Non-responder - Placebo to High Dose
Placebo administered PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
OG003
Part B: Partial-responder - Low Dose to Low Dose
Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
OG004
Part B: Partial- and Non-responder - Low Dose to High Dose
Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
OG005
Part B: Partial- and Non-responder - High Dose to High Dose
Baricitinib administered 8 mg or 10 mg PO QD.
OG006
Part B: Placebo Extension
Placebo PO QD maintained on placebo PO QD.
Units
Counts
Participants
OG00026
OG00157
OG00219
OG00314
OG00441
OG00538
OG0065
Title
Denominators
Categories
Title
Measurements
OG000-1.6± 2.48
OG001-2.6± 3.80
OG002-1.4± 3.15
OG003-1.2± 2.67
OG004-1.6± 2.99
OG005-2.2± 4.64
OG006-3.0± 6.16
Baricitinib 4 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
OG002
Part D: Baricitinib 8 mg - Retreatment
Baricitinib 8 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
OG003
Part D: Baricitinib 10 mg - Retreatment
Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Units
Counts
Participants
OG0000
OG0014
OG0028
OG00314
Title
Denominators
Categories
Title
Measurements
OG001-0.25± 1.708
OG002-0.13± 3.796
OG003-0.86± 2.143
OG002
Part A: Baricitinib 4 mg
Baricitinib 4 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 8 mg or 10 mg PO QD for an additional 12 weeks.
OG003
Part A: Baricitinib 8 mg
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks.
OG004
Part A: Baricitinib 10 mg
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Units
Counts
Participants
OG00027
OG00129
OG00267
OG00360
OG00462
Title
Denominators
Categories
Title
Measurements
OG0002.9± 2.55
OG0015.7± 2.46
OG0026.4± 1.62
OG0039.5± 1.71
OG0047.8± 1.69
OG003
Part B: Partial-responder - Low Dose to Low Dose
Baricitinib administered 2 mg or 4mg PO QD. Randomized to remain on the same dose.
OG004
Part B: Partial- and Non-responder - Low Dose to High Dose
Baricitinib administered 2 mg or 4 mg PO QD re-randomized to baricitinib 8 mg or 10 mg PO QD.
OG005
Part B: Partial- and Non-responder - High Dose to High Dose
Baricitinib administered 8 mg or 10 mg PO QD.
OG006
Part B: Placebo Extension
Placebo PO QD maintained on placebo PO QD.
Units
Counts
Participants
OG00028
OG00158
OG00219
OG00314
OG00442
OG00538
OG0066
Title
Denominators
Categories
Title
Measurements
OG0008.1± 11.41
OG00113.2± 22.06
OG0029.6± 10.78
OG0039.4± 20.95
OG0047.5± 14.47
OG00510.5± 19.94
OG0067.8± 11.92
OG003
Part D: Baricitinib 10 mg - Retreatment
Baricitinib 10 mg administrated PO QD (retreatment with Part B efficacious dose) for 52 weeks.
Units
Counts
Participants
OG0003
OG00113
OG00218
OG00337
Title
Denominators
Categories
Title
Measurements
OG0008.67± 10.263
OG0014.00± 26.920
OG0024.78± 13.571
OG0034.19± 19.727
Baricitinib administered 8 mg PO QD re-randomized to baricitinib 4 mg PO QD. Baricitinib administered 10 mg PO QD re-randomized to baricitinib 4 mg PO QD.
Units
Counts
Participants
OG00015
OG00116
OG00255
OG00355
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG003
Baricitinib 10 mg
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.
Units
Counts
Participants
OG00032
OG00172
OG00273
OG00378
Title
Denominators
Categories
Title
Measurements
OG00052.4± 24.7
OG001106± 25.9
OG002222± 24.4
OG003260± 22.9
Baricitinib 8 mg administered PO QD for initial 12 weeks. At Week 12, depending on participant's response, dose could be increased to baricitinib 10 mg PO QD for an additional 12 weeks
OG003
Baricitinib 10 mg
Baricitinib 10 mg administered PO QD for initial 12 weeks. At Week 12, participants who did not achieve at least a PASI 50 were discontinued from the study.