A Study of Baricitinib (LY3009104) in Participants With S... | NCT03570749 | Trialant
NCT03570749
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Apr 16, 2026Actual
Enrollment
784Actual
Phase
Phase 2Phase 3
Conditions
Alopecia Areata
Interventions
Baricitinib
Placebo
Countries
United States
Japan
Mexico
Puerto Rico
South Korea
Protocol Section
Identification Module
NCT ID
NCT03570749
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16582
Secondary IDs
ID
Type
Description
Link
I4V-MC-JAHO
Other Identifier
Eli Lilly and Company
Brief Title
A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata
Acronym
BRAVE-AA1
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Mar 2026
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
Sep 24, 2018Actual
Primary Completion Date
Feb 2, 2021Actual
Completion Date
Jan 29, 2025Actual
First Submitted Date
Jun 18, 2018
First Submission Date that Met QC Criteria
Jun 18, 2018
First Posted Date
Jun 27, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Jun 23, 2025
Results First Submitted that Met QC Criteria
Sep 11, 2025
Results First Posted Date
Oct 1, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 2, 2022
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Oct 1, 2025Actual
Last Update Submitted Date
Mar 30, 2026
Last Update Posted Date
Apr 16, 2026Actual
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
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. An additional subpopulation of 60 participants in the US will enroll in the open-label addenda.
Detailed Description
Not provided
Conditions Module
Conditions
Alopecia Areata
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
784Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo Phase 2
Placebo Comparator
Participants received three placebo tablets administered orally once daily (QD). Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve Severity of Alopecia Tool (SALT) ≤20 (less than or equal to 20) during the study period.
Drug: Baricitinib
Drug: Placebo
1 Milligram (mg) / 4 mg Baricitinib Phase 2
Experimental
Participants received one 1 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind through Week 12. Following the decision point at Week 12, participants were transitioned to receive one 4 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind, and continued treatment through Week 200.
Drug: Baricitinib
2 mg Baricitinib Phase 2
Experimental
Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
Drug: Baricitinib
4 mg Baricitinib Phase 2
Experimental
Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.
Drug: Baricitinib
Placebo Phase 3
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Baricitinib
Drug
Administered orally.
1 Milligram (mg) / 4 mg Baricitinib Phase 2
2 mg Baricitinib /2 mg Baricitinib Phase 3
2 mg Baricitinib /4 mg Baricitinib Phase 3
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.
Week 36
Percent Change From Baseline in SALT Score - Phase 3 Open-Label Addendum
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100, with lower score indicating better health outcomes.
Baseline, Week 52
Secondary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in SALT Score - Phase 3
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100, with lower score indicating better health outcomes. Least Squares Mean (LSM) was calculated using analysis of covariance (ANCOVA) with geographic region duration of current episode at baseline (< 4 years versus ≥4 years), treatment group, and baseline value in the model.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent.
Must self-identify as either Black or African American in race in the open label addenda.
Have severe or very severe AA, as determined by all of the following:
Current AA episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured by -- Severity of Alopecia Tool (SALT) Alopecia Areata (AA) Investigator Global Assessment (AA-IGA) of 3 or 4) at screening and baseline.
No spontaneous improvement over the past 6 months.
Current episode of severe or very severe AA of less than 8 years.
Male or nonpregnant, nonbreastfeeding female participants.
Exclusion Criteria:
Primarily "diffuse" type of AA.
Are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on AA.
Previously treated with an oral Janus kinase (JAK) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment).
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
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)
King B, Mostaghimi A, Shimomura Y, Piraccini BM, Blume-Peytavi U, Sontag A, Dutronc Y, Denning K, Kolodsick J, Lu X, Srivastava A, Sinclair R. Safety of Baricitinib in Adults with Severe Alopecia Areata from Two Phase III Trials Over a Median of 2.3 Years and Up to 4 Years of Treatment. Am J Clin Dermatol. 2025 Jul;26(4):611-622. doi: 10.1007/s40257-025-00932-0. Epub 2025 Apr 11.
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 European Union (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.
Phase 3 (Weeks 0-248): This phase 3 consisted of two treatment periods: Treatment Period 1 (Weeks 0-52) and Treatment Period 2 (Weeks 52-248), which included randomized withdrawal of baricitinib doses among responders and uptitration among baricitinib 2 mg nonresponders.
Phase 3 Open-Label Addendum (Weeks 0-52): An additional 20 Black or African American participants were enrolled in the United States to evaluate the effectiveness of baricitinib therapy.
Recruitment Details
The study was conducted in three separate parts with no participant overlap:
• Phase 2 (Weeks 0-200): Participants completed 12 weeks of treatment or early discontinuation. At Week 12, an interim analysis was conducted to determine doses for Phase 3. Based on these Phase 2 interim results, subsequent participants in Phase 3 were enrolled and assigned to receive either baricitinib 2 mg or 4 mg.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo Phase 2
Participants received three placebo tablets administered orally once daily (QD). Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve Severity of Alopecia Tool (SALT) ≤20 (less than or equal to 20) during the study period.
FG001
Periods
Title
Milestones
Reasons Not Completed
Phase 2 Period (Week 0 to Week 200)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol: JAHO Protocol (e)_Redacted
Nov 2, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Canada
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Placebo Comparator
Participants received two placebo tablets administered orally QD. Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve SALT≤20 during this treatment period.
Drug: Baricitinib
Drug: Placebo
2 mg Baricitinib Phase 3
Experimental
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Drug: Baricitinib
4 mg Baricitinib Phase 3
Experimental
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Drug: Baricitinib
Placebo/ Placebo Phase 3
Placebo Comparator
Participants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2.
Drug: Placebo
Placebo/ 2 mg Baricitinib Phase 3
Experimental
Participants who received Placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.
Drug: Baricitinib
Placebo/ 4 mg Baricitinib Phase 3
Experimental
Participants who received Placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
Drug: Baricitinib
2 mg Baricitinib /2 mg Baricitinib Phase 3
Experimental
Participants who received 2 mg Baricitinib at Period 1 continued to receive 2 mg Baricitinib dose administered orally QD in Period 2.
Drug: Baricitinib
2 mg Baricitinib /4 mg Baricitinib Phase 3
Experimental
Participants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
Drug: Baricitinib
2 mg Baricitinib / Placebo Phase 3
Experimental
Participants who received 2 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
Drug: Placebo
4 mg Baricitinib / Placebo Phase 3
Experimental
Participants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
Drug: Placebo
4 mg Baricitinib /4 mg Baricitinib Phase 3
Experimental
Participants who received 4 mg Baricitinib at Period 1 continued to receive 4 mg Baricitinib administered orally QD in Period 2.
Drug: Baricitinib
4 mg Baricitinib Phase 3 Open-Label Addendum
Experimental
Participants who received one 4 mg Baricitinib tablet administered orally QD.
Drug: Baricitinib
2 mg Baricitinib Phase 2
2 mg Baricitinib Phase 3
4 mg Baricitinib /4 mg Baricitinib Phase 3
4 mg Baricitinib Phase 2
4 mg Baricitinib Phase 3
4 mg Baricitinib Phase 3 Open-Label Addendum
Placebo Phase 2
Placebo Phase 3
Placebo/ 2 mg Baricitinib Phase 3
Placebo/ 4 mg Baricitinib Phase 3
LY3009104
Placebo
Drug
Administered orally.
2 mg Baricitinib / Placebo Phase 3
4 mg Baricitinib / Placebo Phase 3
Placebo Phase 2
Placebo Phase 3
Placebo/ Placebo Phase 3
Baseline, Week 36
Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3
SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process . The SALT score will range from 0% to 100%. with lower score indicating better health outcomes.
Week 12
Time for Participants to Achieve SALT ≤ 20 at Week 36 - Phase 3
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. Kaplan-Meier method was used for analysis. Time for participants to achieve salt ≤ 20 at week 36 were reported in this outcome measure.
Week 36
Percentage of Participants Achieving Clinician Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥ 2 at Baseline) - Phase 3
ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB.
Week 36
Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥ 2 at Baseline) - Phase 3
ClinRO measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL.
Week 36
Percentage of Participants With Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 With a ≥ 2 Point Improvement From Baseline Among Participants With a Score of ≥ 3 at Baseline - Phase 3
PRO is an assessment of the participant's current extent of scalp involvement. It is comprised of 5 category response options: 0= No missing hair (0% of my scalp is missing hair; I have a full head of hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is missing hair).
Week 36
Percentage of Participants Achieving PRO Measure for EB 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥ 2 at Baseline) - Phase 3
PRO is an assessment of the participant's current appearance of eyebrows. It is comprised of 4 category response options: 0 = I have full EB on each eye; 1= I have a minimal gap(s) or a minimal amount of thinning in at least 1 of my EB; 2 = I have a large gap(s) or a large amount of thinning in at least 1 of my EB; and 3 = I have no or barely any EB hairs.
Week 36
Percentage of Participants Achieving PRO Measure for EL 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With PRO Measure EL ≥2 at Baseline) - Phase 3
PRO assessment of the participant's current appearance of EL. It is comprised of 4 category response options: 0 = I have full EL on each eyelid; 1 = I have a minimal gap or minimal gaps along the eyelids; 2 = I have a large gap or large gaps along the eyelids; and 3 = I have no or barely any EL hair.
Week 36
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score - Phase 3
The Hospital Anxiety Depression Scale (HADS) is a 14 item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (e.g., 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.
LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.
Baseline, Week 36
Mean Change From Baseline in HADS Depression Score - Phase 3
The HADS is a 14 item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (e.g., 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.
LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.
Baseline, Week 36
Percentage of Participants Achieving SALT ≤ 20 - Phase 3 Open-Label Addendum
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.
Week 52
Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3 Open-Label Addendum
SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process . The SALT score will range from 0% to 100%. with lower score indicating better health outcomes.
Week 52
Percentage of Participants Achieving ClinRO Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥ 2 at Baseline) - Phase 3 Open-Label Addendum
ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB.
Week 52
Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥ 2 at Baseline) - Phase 3 Open-Label Addendum
ClinRO measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL.
Week 52
Percentage of Participants With Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 With a ≥ 2 Point Improvement From Baseline Among Participants With a Score of ≥ 3 at Baseline - Phase 3 Open-Label Addendum
PRO is an assessment of the participant's current extent of scalp involvement. It is comprised of 5 category response options: 0= No missing hair (0% of my scalp is missing hair; I have a full head of hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is missing hair).
Week 52
Mobile
Alabama
36608
United States
Johnson Dermatology
Fort Smith
Arkansas
72916
United States
California Dermatology & Clinical Research Institute
Encinitas
California
92024
United States
Alliance Research Centers
Irvine
California
92612
United States
University of CA, Irvine
Irvine
California
92617
United States
Dermatology Research Associates
Los Angeles
California
90045
United States
Stanford Health Care
Redwood City
California
94063
United States
University of California Davis-Dermatology
Sacramento
California
95816
United States
University Clinical Trials, Inc.
San Diego
California
92123
United States
Mosaic Dermatology
Santa Monica
California
90403
United States
Yale University School of Medicine
New Haven
Connecticut
06519
United States
Solutions Through Advanced Research, Inc.
Jacksonville
Florida
32256
United States
University of Miami
Miami
Florida
33125
United States
Park Avenue Dermatology
Orange Park
Florida
32073
United States
ForCare Clinical Research
Tampa
Florida
33613-1244
United States
Skin Care Physicians of Georgia
Macon
Georgia
31217
United States
Medaphase Inc
Newnan
Georgia
30263
United States
Northwestern University
Chicago
Illinois
60611
United States
Forefront Research
Louisville
Kentucky
40241
United States
Callender Center for Clinical Research, LLC / Research
Glenn Dale
Maryland
20769
United States
ActivMed Practices and Research
Beverly
Massachusetts
01915
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Brigham and Women's Hospital
Boston
Massachusetts
02115
United States
Clarkston Skin Research
Clarkston
Michigan
48346
United States
University of Minnesota Medical School
Minneapolis
Minnesota
55455
United States
ActivMed Practices and Research
Portsmouth
New Hampshire
03801
United States
University of Rochester School of Medicine
Rochester
New York
14642
United States
Montefiore Medical Center
The Bronx
New York
10467-2490
United States
University Hospitals Cleveland Medical Center
Cleveland
Ohio
44106
United States
Cleveland Clinic Foundation
Cleveland
Ohio
44195
United States
OH State Univ College of Med
Gahanna
Ohio
43230
United States
NW Dermatology & Research Center, LLC
Portland
Oregon
97210
United States
Oregon Medical Research Center
Portland
Oregon
97223
United States
OHSU Center for Health and Healing
Portland
Oregon
97239
United States
Dermatology and Skin Surgery Center
Exton
Pennsylvania
19341
United States
Penn State Univ. Milton S. Hershey Medical Center
Hershey
Pennsylvania
17033
United States
Perelman Center for Advanced Medicine
Philadelphia
Pennsylvania
19104
United States
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
15213
United States
Dermatology Associates of Plymouth Meeting
Plymouth Meeting
Pennsylvania
19462
United States
Medical University of South Carolina
Charleston
South Carolina
29425
United States
Bellaire Dermatology
Bellaire
Texas
77401
United States
Modern Research Associates
Dallas
Texas
75231
United States
Center for Clinical Studies
Houston
Texas
77004
United States
Austin Institute for Clinical Research
Pflugerville
Texas
78660
United States
Texas Dermatology and Laser Specialists
San Antonio
Texas
78218
United States
Dermatology Clinical Research Center of San Antonio
San Antonio
Texas
78229
United States
Center for Clinical Studies
Webster
Texas
77598
United States
University of Utah MidValley Dematology
Murray
Utah
84107
United States
Dermatology Associates
Seattle
Washington
98101
United States
Kurume University Hospital
Kurume
Fukuoka
830 0011
Japan
Hamamatsu University School of Medicine, University Hospital
Hamamatsu
Shizuoka
431-3192
Japan
Tokyo Medical Univ. Hospital
Shinjuku-ku
Tokyo
160-0023
Japan
Osaka City University Hospital
Osaka
545-8586
Japan
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara
Jalisco
44650
Mexico
Consultorio Privado de la Dra. Villanueva
Guadalajara
Jalisco
44657
Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey
N.L.
64460
Mexico
CRI Centro Regiomontano de Investigacion S.C.
Monterrey
Nuevo León
64060
Mexico
B&B Investigaciones Medicas, SC
Mazatlán
Sinaloa
82140
Mexico
Derma Norte del BajÃo, S.C.
Aguascalientes
Mexico
RM Pharma Specialists S.A. de C.V.
Distrito Federal
3100
Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango
34000
Mexico
Ponce School of Medicine CAIMED Center
Ponce
PR
00716
Puerto Rico
GCM Medical Group, PSC- Hato Rey
San Juan
PR
00917
Puerto Rico
Seoul National University Bundang Hospital
Seongnam
Geonggi-do
13620
South Korea
Inha University Hospital
Jung-gu
Incheon
22332
South Korea
Chonbuk National University Hospital
Jeonju
Jeon Ra Buk-Do, Korea
54907
South Korea
Pusan National University Hospital
Busan
Korea
49241
South Korea
Kyung Pook National University Hospital
Daegu
Korea
41944
South Korea
Chungnam National University Hospital
Daejeon
Korea
35015
South Korea
Seoul National University Hospital
Seoul
03080
South Korea
Eunpyeong St. Mary's Hospital
Seoul
03312
South Korea
Konkuk University Medical Center
Seoul
05030
South Korea
Kyunghee University Hospital at Gangdong
Seoul
05278
South Korea
Chungang University Hospital
Seoul
06973
South Korea
Derived
King B, Ko J, Kwon O, Vano-Galvan S, Piraccini BM, Dutronc Y, Yu G, Liu C, Somani N, Ball S, Mesinkovska NA. Baricitinib Withdrawal and Retreatment in Patients With Severe Alopecia Areata: The BRAVE-AA1 Randomized Clinical Trial. JAMA Dermatol. 2024 Oct 1;160(10):1075-1081. doi: 10.1001/jamadermatol.2024.2734.
Craiglow B, Lee YW, Vano-Galvan S, Egeberg A, Dutronc Y, Durand F, Pierce E, Yu G, Chen YF, Mostaghimi A. Improvement in Measures of Quality of Life and Symptoms of Anxiety and Depression in Patients with Severe Alopecia Areata Achieving Sustained Scalp Hair Regrowth with Baricitinib. Dermatol Ther (Heidelb). 2024 Jul;14(7):1959-1968. doi: 10.1007/s13555-024-01208-x. Epub 2024 Jun 21.
Senna MM, Kwon O, Piraccini BM, Sinclair R, Ball S, Ding Y, Chen YF, Dutronc Y, King B. Clinical Benefits of Baricitinib Therapy According to Scalp Hair Regrowth in Patients with Severe Alopecia Areata. Dermatol Ther (Heidelb). 2023 Dec;13(12):3209-3220. doi: 10.1007/s13555-023-01063-2. Epub 2023 Nov 22.
Ko JM, Mayo TT, Bergfeld WF, Dutronc Y, Yu G, Ball SG, Somani N, Craiglow BG. Clinical Outcomes for Uptitration of Baricitinib Therapy in Patients With Severe Alopecia Areata: A Pooled Analysis of the BRAVE-AA1 and BRAVE-AA2 Trials. JAMA Dermatol. 2023 Sep 1;159(9):970-976. doi: 10.1001/jamadermatol.2023.2581.
Piraccini BM, Ohyama M, Craiglow B, Bewley A, Ding Y, Chen YF, Dutronc Y, Pierce E, Durand F, Mostaghimi A. Scalp hair regrowth is associated with improvements in health-related quality of life and psychological symptoms in patients with severe alopecia areata: results from two randomized controlled trials. J Dermatolog Treat. 2023 Dec;34(1):2227299. doi: 10.1080/09546634.2023.2227299.
Kwon O, Senna MM, Sinclair R, Ito T, Dutronc Y, Lin CY, Yu G, Chiasserini C, McCollam J, Wu WS, King B. Efficacy and Safety of Baricitinib in Patients with Severe Alopecia Areata over 52 Weeks of Continuous Therapy in Two Phase III Trials (BRAVE-AA1 and BRAVE-AA2). Am J Clin Dermatol. 2023 May;24(3):443-451. doi: 10.1007/s40257-023-00764-w. Epub 2023 Mar 1.
King B, Mostaghimi A, Shimomura Y, Zlotogorski A, Choi GS, Blume-Peytavi U, Passeron T, Holzwarth K, Dutronc Y, McCollam J, Yang FE, Stanley S, Wu WS, Sinclair R. Integrated safety analysis of baricitinib in adults with severe alopecia areata from two randomized clinical trials. Br J Dermatol. 2023 Feb 10;188(2):218-227. doi: 10.1093/bjd/ljac059.
King B, Ohyama M, Kwon O, Zlotogorski A, Ko J, Mesinkovska NA, Hordinsky M, Dutronc Y, Wu WS, McCollam J, Chiasserini C, Yu G, Stanley S, Holzwarth K, DeLozier AM, Sinclair R; BRAVE-AA Investigators. Two Phase 3 Trials of Baricitinib for Alopecia Areata. N Engl J Med. 2022 May 5;386(18):1687-1699. doi: 10.1056/NEJMoa2110343. Epub 2022 Mar 26.
1 Milligram (mg) / 4 mg Baricitinib Phase 2
Participants received one 1 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind through Week 12. Following the decision point at Week 12, participants were transitioned to receive one 4 mg baricitinib tablet administered orally QD and two placebo tablets administered orally QD to maintain the blind, and continued treatment through Week 200.
FG002
2 mg Baricitinib Phase 2
Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
FG003
4 mg Baricitinib Phase 2
Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.
FG004
Placebo Phase 3
Participants received two placebo tablets administered orally QD. Rescue therapy with Baricitinib 2 mg or 4 mg was provided to participants who failed to achieve SALT≤20 during this treatment period.
FG005
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
FG006
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
FG007
Placebo/ Placebo Phase 3
Participants who received two placebo tablets administered orally QD in Period 1 continue to receive the same placebo in Period 2.
FG008
Placebo/ 2 mg Baricitinib Phase 3
Participants who received Placebo at Period 1 switched to receive 2 mg Baricitinib dose administered orally QD in Period 2.
FG009
Placebo/ 4 mg Baricitinib Phase 3
Participants who received Placebo at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
FG010
2 mg Baricitinib /2 mg Baricitinib Phase 3
Participants who received 2 mg Baricitinib at Period 1 continued to receive 2 mg Baricitinib dose administered orally QD in Period 2.
FG011
2 mg Baricitinib /4 mg Baricitinib Phase 3
Participants who received 2 mg Baricitinib at Period 1 switched to receive 4 mg Baricitinib dose administered orally QD in Period 2.
FG012
2 mg Baricitinib / Placebo Phase 3
Participants who received 2 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
FG013
4 mg Baricitinib / Placebo Phase 3
Participants who received 4 mg Baricitinib at Period 1 switched to receive Placebo administered orally QD in Period 2.
FG014
4 mg Baricitinib /4 mg Baricitinib Phase 3
Participants who received 4 mg Baricitinib at Period 1 continued to receive 4 mg Baricitinib administered orally QD in Period 2.
FG015
4 mg Baricitinib Phase 3 Open-Label Addendum
Participants who received one 4 mg Baricitinib tablet administered orally QD.
FG00028 subjects
FG00128 subjects
FG00227 subjects
FG00327 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
Safety Population
All randomized participants who received at least one (≥1) dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit.
FG00028 subjectsAs pre-specified in the statistical analysis plan (SAP), adverse events (AE) were reported according to randomized treatment assignment at Week 0. Participants in the placebo, 2 mg, and 4 mg baricitinib arms were included for the period they were continuously treated with their assigned dose and censored at the time of dose change or permanent treatment discontinuation.
FG00128 subjects
FG00227 subjects
FG00327 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
All Baricitinib Phase 2 (Combined Baricitinib: 1 mg/4 mg, 2 mg and 4 mg) -Safety Population
As pre-specified in the SAP, " All Baricitinib " included participants who received ≥1 dose of Baricitinib at any time during treatment, including placebo rescues :1 mg/4 mg arm (n=28), 2 mg (n=27), 4 mg (n=27), and rescued placebo (n=24); Total N=106. The "1 mg/4 mg Baricitinib Phase 2" arm AE data was included in "All BARI" and not reported separately in the AE section of results record.
FG00024 subjects
FG00128 subjects
FG00227 subjects
FG00327 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
COMPLETED
Protocol-specified discontinuation criteria: Participants who were nonresponders (SALT score >20 at both Week 52 and Week 76) were discontinued from the study at Week 76.
FG00010 subjects
FG00111 subjects
FG00215 subjects
FG00316 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
NOT COMPLETED
FG00018 subjects
FG00117 subjects
FG00212 subjects
FG00311 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
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 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
Lack of Efficacy
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0016 subjects
FG0021 subjects
FG0031 subjects
FG004
Pregnancy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0008 subjects
FG0015 subjects
FG0026 subjects
FG0033 subjects
FG004
Protocol Defined Discontinuation Criteria Met at Week 76
FG0007 subjects
FG0014 subjects
FG0022 subjects
FG0035 subjects
Did Not Meet Study Criteria; Out of range labs
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Site procedural error; participant initiated commercial treatment
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Phase 3 Period 1 (Week 0 to Week 52)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004189 subjects
FG005184 subjects
FG006281 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Safety Population
All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All Baricitinib Phase 3 (Combined Baricitinib: 2 mg and 4 mg) - Safety Population
As pre-specified in the SAP, " All Baricitinib " included participants who received ≥1 dose of Baricitinib at any time during treatment, including placebo rescues: 2 mg (n=183), 4 mg (n=280), and rescued placebo (n=156);Total N= 619.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
COMPLETED
Participants who completed Week 52
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Phase 3 Period 2 (Week 52 to Week 248)
Type
Comment
Milestone Data
STARTED
One participant who completed Phase 3 Period 1 did not enter Period 2, resulting in 573 participants starting Phase 3 Period 2 compared to 574 who completed Period 1.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0079 subjects
FG00876 subjects
FG00973 subjects
FG01032 subjects
FG011121 subjects
FG01210 subjects
FG013109 subjects
FG014143 subjects
FG0150 subjects
COMPLETED
Protocol-specified discontinuation criteria: Participants who were nonresponders (SALT score >20 at both Week 52 and Week 76) were discontinued from the study at Week 76.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Phase 3 Open Label Addendum (Week 0-52)
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 subjects
FG0130 subjects
FG0140 subjects
FG01520 subjects
Safety Population
All randomized participants who received at least one dose of the study drug and who did not discontinue from the study for the reason 'Lost to Follow-up' at the first post-baseline visit.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants from Phase 2, Phase 3, and the Phase 3 open-label addendum.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo Phase 2
Participants received three placebo tablets administered orally every day (QD).
BG001
1 mg Baricitinib Phase 2
Participants received one 1 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
BG002
2 mg Baricitinib Phase 2
Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
BG003
4 mg Baricitinib Phase 2
Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablet administered orally QD to maintain the blind.
BG004
Placebo Phase 3
Participants received two placebo tablets administered orally QD.
BG005
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
BG006
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally, QD and one placebo tablet QD administered orally to maintain the blind.
BG007
4 mg Baricitinib Phase 3 Open-Label Addendum
Participants who received one 4 mg Baricitinib tablet administered orally QD.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00028
BG00128
BG00227
BG00327
BG004189
BG005184
BG006281
BG00720
BG008784
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
The number analyzed includes only participants with observed (non-missing) data for each specific baseline characteristic. In the "4 mg Baricitinib Phase 3" arm, age data for one participant was not collected and therefore couldn't be reported (n=280).
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00028
ParticipantsBG00128
ParticipantsBG00227
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG00028
ParticipantsBG00128
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG00028
ParticipantsBG00128
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
South Korea
ParticipantsBG00028
ParticipantsBG00128
ParticipantsBG002
Baseline Disease Severity of Alopecia Tool (SALT) Score
SALT uses a visual aid showing the division of the scalp hair into 4 areas - top of the head constituting 40% of total surface, the posterior/back of head 24%, right and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account for scoring. The score will range from 0% to 100%, with lower score indicating better health outcomes.
Mean
Standard Deviation
units on a scale
Title
Denominators
Categories
ParticipantsBG00028
ParticipantsBG001
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 Severity of Alopecia Tool (SALT) ≤ 20 - Phase 3
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.
All randomized phase 3 participants who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
Posted
Number
95% Confidence Interval
percentage of participants
Week 36
ID
Title
Description
OG000
Placebo Phase 3
Participants received two placebo tablets administered orally every day (QD).
OG001
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
OG002
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally, every day QD, and one placebo tablet administered orally QD to maintain the blind.
Units
Counts
Participants
OG000189
OG001184
OG002281
Title
Denominators
Categories
Title
Measurements
OG0005.3(2.9 to 9.5)
OG00121.7(16.4 to 28.2)
OG00235.2(29.9 to 41.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
<0.001
Odds Ratio (OR)
5.75
2-Sided
95
2.75
12.02
Superiority
OG000
OG002
Regression, Logistic
<0.001
Primary
Percent Change From Baseline in SALT Score - Phase 3 Open-Label Addendum
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100, with lower score indicating better health outcomes.
All randomized phase 3 open-label addendum participants who had evaluable data for this outcome measure.
Posted
Mean
Standard Deviation
percent change
Baseline, Week 52
ID
Title
Description
OG000
4 mg Baricitinib Phase 3 Open-Label Addendum
Participants who received one 4 mg Baricitinib tablet administered orally QD.
Units
Counts
Participants
OG000
Secondary
Percent Change From Baseline in SALT Score - Phase 3
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100, with lower score indicating better health outcomes. Least Squares Mean (LSM) was calculated using analysis of covariance (ANCOVA) with geographic region duration of current episode at baseline (< 4 years versus ≥4 years), treatment group, and baseline value in the model.
All randomized phase 3 participants with non-missing baseline and at least one post-baseline measurement who had evaluable data for this outcome measure.A modified last observation carried forward (mLOCF) imputation technique was used to replace missing data with the most recent non-missing post-baseline assessment.
Posted
Least Squares Mean
Standard Error
percent change
Baseline, Week 36
ID
Title
Description
OG000
Placebo Phase 3
Participants received two placebo tablets administered orally QD.
OG001
2 mg Baricitinib Phase 3
Secondary
Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3
SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process . The SALT score will range from 0% to 100%. with lower score indicating better health outcomes.
All randomized phase 3 participants who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
Posted
Number
95% Confidence Interval
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo Phase 3
Participants received two placebo tablets administered orally every day QD.
OG001
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Secondary
Time for Participants to Achieve SALT ≤ 20 at Week 36 - Phase 3
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes. Kaplan-Meier method was used for analysis. Time for participants to achieve salt ≤ 20 at week 36 were reported in this outcome measure.
All randomized phase 3 participants who had evaluable data for this outcome measure.
Posted
Median
95% Confidence Interval
Days
Week 36
ID
Title
Description
OG000
Placebo Phase 3
Participants received two placebo tablets administered orally every day QD.
OG001
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
OG002
Secondary
Percentage of Participants Achieving Clinician Reported Outcome (ClinRO) Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥ 2 at Baseline) - Phase 3
ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB.
All randomized phase 3 participants with baseline ClinRO measure for EB Hair Loss ≥ 2 and who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
Posted
Number
95% Confidence Interval
percentage of participants
Week 36
ID
Title
Description
OG000
Placebo Phase 3
Participants received two placebo tablets administered orally QD.
OG001
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
OG002
4 mg Baricitinib Phase 3
Secondary
Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥ 2 at Baseline) - Phase 3
ClinRO measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL.
All randomized phase 3 participants with baseline ClinRO measure for EL hair loss ≥ 2 and who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
Posted
Number
95% Confidence Interval
percentage of participants
Week 36
ID
Title
Description
OG000
Placebo Phase 3
Participants received two placebo tablets administered orally QD.
OG001
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
OG002
4 mg Baricitinib Phase 3
Secondary
Percentage of Participants With Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 With a ≥ 2 Point Improvement From Baseline Among Participants With a Score of ≥ 3 at Baseline - Phase 3
PRO is an assessment of the participant's current extent of scalp involvement. It is comprised of 5 category response options: 0= No missing hair (0% of my scalp is missing hair; I have a full head of hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is missing hair).
All randomized phase 3 participants with baseline PRO for scalp hair assessment of ≥ 3 and who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
Posted
Number
95% Confidence Interval
percentage of participants
Week 36
ID
Title
Description
OG000
Placebo Phase 3
Participants received two placebo tablets administered orally QD.
OG001
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
OG002
Secondary
Percentage of Participants Achieving PRO Measure for EB 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With PRO Measure for EB ≥ 2 at Baseline) - Phase 3
PRO is an assessment of the participant's current appearance of eyebrows. It is comprised of 4 category response options: 0 = I have full EB on each eye; 1= I have a minimal gap(s) or a minimal amount of thinning in at least 1 of my EB; 2 = I have a large gap(s) or a large amount of thinning in at least 1 of my EB; and 3 = I have no or barely any EB hairs.
All randomized phase 3 participants with baseline PRO measure for EB ≥ 2 and who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
Posted
Number
95% Confidence Interval
percentage of participants
Week 36
ID
Title
Description
OG000
Placebo Phase 3
Participants received two placebo tablets administered orally QD.
OG001
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
OG002
4 mg Baricitinib Phase 3
Secondary
Percentage of Participants Achieving PRO Measure for EL 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With PRO Measure EL ≥2 at Baseline) - Phase 3
PRO assessment of the participant's current appearance of EL. It is comprised of 4 category response options: 0 = I have full EL on each eyelid; 1 = I have a minimal gap or minimal gaps along the eyelids; 2 = I have a large gap or large gaps along the eyelids; and 3 = I have no or barely any EL hair.
All randomized phase 3 participants with baseline with baseline PRO measure for EL ≥ 2 and who had evaluable data for this outcome measure. A Non-responder Imputation (NRI) was applied for participants with missing data at the timepoint due to discontinuation or other intercurrent events.
Posted
Number
95% Confidence Interval
percentage of participants
Week 36
ID
Title
Description
OG000
Placebo Phase 3
Participants received two placebo tablets administered orally QD.
OG001
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
OG002
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Secondary
Mean Change From Baseline in Hospital Anxiety Depression Scale (HADS) Anxiety Score - Phase 3
The Hospital Anxiety Depression Scale (HADS) is a 14 item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (e.g., 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.
LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.
All randomized phase 3 participants with non-missing baseline and at least one post-baseline measurement who had evaluable data for this outcome measure. The method used to handle missing data will be mLOCF which used the most recent nonmissing postbaseline assessment.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 36
ID
Title
Description
OG000
Placebo Phase 3
Participants received two placebo tablets administered orally QD.
OG001
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Secondary
Mean Change From Baseline in HADS Depression Score - Phase 3
The HADS is a 14 item self-assessment scale that determines the levels of anxiety and depression that a patient is experiencing over the past week. The HADS utilizes a 4-point Likert scale (e.g., 0 to 3) for each question and is intended for ages 12 to 65 years. Scores for each domain (anxiety and depression) can range from 0 to 21, with higher scores indicating greater anxiety or depression.
LS mean was calculated using an ANCOVA model which includes geographic region, duration of current episode at baseline (<4 years vs. ≥4 years), treatment group and baseline score as fixed factors.
All randomized phase 3 participants with non-missing baseline and at least one post-baseline measurement who had evaluable data for this outcome measure. The method used to handle missing data will be mLOCF which used the most recent nonmissing postbaseline assessment.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 36
ID
Title
Description
OG000
Placebo Phase 3
Participants received two placebo tablets administered orally QD.
OG001
2 mg Baricitinib Phase 3
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
OG002
4 mg Baricitinib Phase 3
Secondary
Percentage of Participants Achieving SALT ≤ 20 - Phase 3 Open-Label Addendum
The SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process. The SALT score will range from 0% to 100%, with lower score indicating better health outcomes.
All randomized phase 3 open-label addendum participants who had evaluable data for this outcome measure.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
4 mg Baricitinib Phase 3 Open-Label Addendum
Participants who received one 4 mg Baricitinib tablet administered orally QD.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants Achieving 50% Improvement of SALT (SALT50) - Phase 3 Open-Label Addendum
SALT uses a visual aid showing the division of the scalp hair into 4 areas with the top of the head constituting 40% of total surface, the posterior/back of head 24%, right side and left side of head 18% each. The percentage of hair loss in each area is determined and is multiplied by the percentage of scalp covered by that area. The total sum of the 4 products of each area will give the SALT score, as developed by the National Alopecia Areata Foundation Working Committee. Only terminal hair is included in the SALT; vellus hair or any fine downy hair is not taken into account in the SALT scoring process . The SALT score will range from 0% to 100%. with lower score indicating better health outcomes.
All randomized phase 3 open-label addendum participants who had evaluable data for this outcome measure.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
4 mg Baricitinib Phase 3 Open-Label Addendum
Participants who received one 4 mg Baricitinib tablet administered orally QD.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants Achieving ClinRO Measure for Eyebrow (EB) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EB Hair Loss ≥ 2 at Baseline) - Phase 3 Open-Label Addendum
ClinRO is a clinician reported assessment which measures a participant's EB hair loss. It is comprised of 4 category response options: 0 = EB have full coverage and no areas of hair loss; 1 = There are minimal gaps in EB hair and distribution is even; 2 = There are significant gaps in EB hair or distribution is not even; 3 = No notable EB.
All randomized phase 3 open-label addendum participants with baseline ClinRO measure for EB Hair Loss ≥ 2 and who had evaluable data for this outcome measure.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
4 mg Baricitinib Phase 3 Open-Label Addendum
Participants who received one 4 mg Baricitinib tablet administered orally QD.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants Achieving ClinRO Measure for Eyelash (EL) Hair Loss 0 or 1 With ≥ 2-point Improvement From Baseline (Among Participants With ClinRO Measure for EL Hair Loss ≥ 2 at Baseline) - Phase 3 Open-Label Addendum
ClinRO measure for EL hair loss is comprised of 4 category response options: 0 = The EL form a continuous line along the eyelids on both eyes; 1 = There are minimal gaps and the EL are evenly spaced along the eyelids on both eyes; 2 = There are significant gaps along the eyelids or the EL are not evenly spaced along the eyelids; 3 = No notable EL.
All randomized phase 3 open-label addendum participants with baseline ClinRO measure for EL hair loss ≥ 2 and who had evaluable data for this outcome measure.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
4 mg Baricitinib Phase 3 Open-Label Addendum
Participants who received one 4 mg Baricitinib tablet administered orally QD.
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With Patient Reported Outcome (PRO) for Scalp Hair Assessment Score of 0 or 1 With a ≥ 2 Point Improvement From Baseline Among Participants With a Score of ≥ 3 at Baseline - Phase 3 Open-Label Addendum
PRO is an assessment of the participant's current extent of scalp involvement. It is comprised of 5 category response options: 0= No missing hair (0% of my scalp is missing hair; I have a full head of hair); 1 = A limited area (1% to 20% of my scalp is missing hair); 2 = A moderate area (21% to 49% of my scalp is missing hair); 3 = A large area (50% to 94% of my scalp is missing hair); and 4 = Nearly all or all (95% to 100% of my scalp is missing hair).
All randomized phase 3 open-label addendum participants with baseline PRO for scalp hair assessment of ≥ 3 and who had evaluable data for this outcome measure.
Posted
Number
95% Confidence Interval
percentage of participants
Week 52
ID
Title
Description
OG000
4 mg Baricitinib Phase 3 Open-Label Addendum
Participants who received one 4 mg Baricitinib tablet administered orally QD.
Units
Counts
Participants
OG000
Time Frame
Phase 2: Baseline up to Week 204 ; Phase 3: Baseline up to Week 252 ; Phase 3 Open-Label addendum : Baseline up to Week 56. (AE Description: As pre-specified in the SAP, AE were assessed using the "safety population". Given the sequential dose change within the Phase 2 Baricitinib 1 mg/4 mg Arm, it was not appropriate to attribute AEs to a single fixed dose, and therefore AEs were not collected separately. Also AE data were not collected separately for the Phase 3 Period 2 Arms.)
Description
(continued) As pre-specified in the SAP, AEs across the full study period (Weeks 0-248) were analyzed according to each participant's randomized treatment assignment at Week 0, with participants censored at the time of any dose change or permanent treatment discontinuation. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo Phase 2
- Week 0 to Week 200: Participants received three placebo tablets administered orally QD.
0
28
0
28
12
28
EG001
2 mg Baricitinib Phase 2
- Week 0 to Week 200: Participants received one 2 mg Baricitinib tablet administered orally QD, and two placebo tablets administered orally QD to maintain the blind.
0
27
0
27
21
27
EG002
4 mg Baricitinib Phase 2
- Week 0 to Week 200: Participants received one 4 mg Baricitinib tablet administered orally, QD and two placebo tablets QD administered orally to maintain the blind.
0
27
2
27
19
27
EG003
All Baricitinib Phase 2 (Combined Baricitinib: 1 mg/4 mg, 2 mg and 4 mg)
Participants who received Baricitinib in any of the three treatment arms [1 mg/4 mg arm (1 mg until Week 12, then 4 mg until Week 200), 2 mg arm, or 4 mg arm], plus Placebo participants who were rescued to Baricitinib at any time during the treatment period (Week 0 to Week 200) of Phase 2 were grouped in this arm.
0
106
3
106
79
106
EG004
Placebo Phase 3
Week 0 to Week 52: Participants received two placebo tablets matched to baricitinib, administered orally QD to maintain the blind (Period 1).
Week 52 to Week 248: Participants continued to receive the same placebo or switched to either 2 mg or 4 mg Baricitinib dose administered orally QD (Period 2).
0
189
3
189
37
189
EG005
2 mg Baricitinib Phase 3
Week 0 to Week 52: Participants received one 2 mg Baricitinib tablet administered orally QD and one placebo tablet administered orally QD to maintain the blind (Period 1).
Week 52 to Week 248: Participants continued to receive the same 2 mg dose or switched to an uptitrated 4 mg Baricitinib dose administered orally QD (Period 2).
0
183
7
183
58
183
EG006
4 mg Baricitinib Phase 3
Week 0 to Week 52: Participants received one 4 mg Baricitinib tablet and one placebo tablet administered orally QD to maintain the blind (Period 1).
Week 52 to Week 248: Participants continued to receive the same 4 mg dose or switched to a downtitrated 2 mg Baricitinib dose, or receive placebo tablets matched to Baricitinib administered orally QD (Period 2).
0
280
16
280
126
280
EG007
All Baricitinib Phase 3 (Combined Baricitinib: 2 mg and 4 mg)
Participants who received Baricitinib in any of 2 mg arm or the 4 mg arm, plus Placebo participants who were rescued to Baricitinib at any time during the treatment period (Week 0 to Week 248) of Phase 3 were grouped in this arm.
0
619
40
619
275
619
EG008
4 mg Baricitinib Phase 3 Open-Label Addendum
Week 0 to Week 52: Participants who received one 4 mg Baricitinib tablet administered orally QD.
0
19
1
19
13
19
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG0030 events0 affected106 at risk
EG0040 events0 affected189 at risk
EG0050 events0 affected183 at risk
EG0060 events0 affected280 at risk
EG0071 events1 affected619 at risk
EG0080 events0 affected19 at risk
Acute myocardial infarction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Gastric stenosis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Peptic ulcer haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Asthenia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Cyst
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Drug withdrawal syndrome
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0021 events1 affected27 at risk
EG003
Hepatitis acute
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Covid-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Covid-19 pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Lyme disease
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Varicella
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Anastomotic ulcer
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Craniofacial fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected27 at risk
EG003
Chronic lymphocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
FG004189 subjectsAs pre-specified in the statistical analysis plan (SAP), adverse events were reported according to randomized treatment assignment at Week 0. Participants in the placebo, 2 mg, and 4 mg baricitinib arms were included for the period they were continuously treated with their assigned dose and censored at the time of dose change or permanent treatment discontinuation.
FG005183 subjects
FG006280 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
0 subjects
FG004156 subjects
FG005183 subjects
FG006280 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG004159 subjects
FG005163 subjects
FG006252 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
30 subjects
FG00521 subjects
FG00629 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
0 subjects
FG0041 subjects
FG0052 subjects
FG0065 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0046 subjects
FG0057 subjects
FG0064 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Due to Pandemic
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Pregnancy
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
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00417 subjects
FG00510 subjects
FG00614 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Randomized, Not treated
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
Lack of Adherence
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Non-compliant with protocol
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
Sponsor 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
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Participant relocated and could not come to site visits
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0076 subjects
FG00827 subjects
FG00937 subjects
FG01020 subjects
FG01160 subjects
FG0127 subjects
FG01329 subjects
FG01496 subjects
FG0150 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
FG00849 subjects
FG00936 subjects
FG01012 subjects
FG01161 subjects
FG0123 subjects
FG01380 subjects
FG01447 subjects
FG0150 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0084 subjects
FG0091 subjects
FG0102 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0144 subjects
FG0150 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0087 subjects
FG0094 subjects
FG0102 subjects
FG0114 subjects
FG0120 subjects
FG0138 subjects
FG0145 subjects
FG0150 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0085 subjects
FG0093 subjects
FG0101 subjects
FG0119 subjects
FG0122 subjects
FG0138 subjects
FG01412 subjects
FG0150 subjects
Protocol Defined Discontinuation Criteria Met at Week 76
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00822 subjects
FG00919 subjects
FG0100 subjects
FG01136 subjects
FG0120 subjects
FG01351 subjects
FG0144 subjects
FG0150 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0143 subjects
FG0150 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
FG0089 subjects
FG0096 subjects
FG0103 subjects
FG01111 subjects
FG0120 subjects
FG01311 subjects
FG01419 subjects
FG0150 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Due to Pandemic
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Site Closed
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
FG0150 subjects
Protocol Deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0101 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Due to time constraints and inability to attend required study visits
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
Met Exclusion criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
FG0150 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
FG01519 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG01511 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0159 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
FG0153 subjects
Randomized but Not Treated
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
FG0151 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
FG0155 subjects
27
ParticipantsBG004189
ParticipantsBG005184
ParticipantsBG006280
ParticipantsBG00720
ParticipantsBG008783
Title
Measurements
BG00040.5± 14.23
BG00138.6± 11.26
BG00242.5± 13.75
BG00342.4± 14.91
BG00437.4± 12.91
BG00538.0± 12.78
BG00636.3± 13.27
BG00746.0± 8.75
BG00837.8± 13.0
27
ParticipantsBG00327
ParticipantsBG004189
ParticipantsBG005184
ParticipantsBG006281
ParticipantsBG00720
ParticipantsBG008784
Title
Measurements
Female
BG00016
BG00118
BG00223
BG00325
BG004109
BG005109
BG006165
BG00715
BG008480
Male
BG00012
BG00110
BG0024
BG0032
BG004
27
ParticipantsBG00327
ParticipantsBG004189
ParticipantsBG005184
ParticipantsBG006281
ParticipantsBG00720
ParticipantsBG008784
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0031
BG0048
BG0055
BG0068
BG0070
BG00822
Asian
BG0003
BG0014
BG0023
BG0034
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0004
BG0012
BG0023
BG0033
BG004
White
BG00021
BG00122
BG00220
BG00319
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0030
BG004
27
ParticipantsBG00327
ParticipantsBG004189
ParticipantsBG005184
ParticipantsBG006281
ParticipantsBG00720
ParticipantsBG008784
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG00470
BG00570
BG006107
BG0070
BG008247
United States
ParticipantsBG00028
ParticipantsBG00128
ParticipantsBG00227
ParticipantsBG00327
ParticipantsBG004189
ParticipantsBG005184
ParticipantsBG006281
ParticipantsBG00720
ParticipantsBG008784
Title
Measurements
BG00025
BG00125
BG00224
BG003
Japan
ParticipantsBG00028
ParticipantsBG00128
ParticipantsBG00227
ParticipantsBG00327
ParticipantsBG004189
ParticipantsBG005184
ParticipantsBG006281
ParticipantsBG00720
ParticipantsBG008784
Title
Measurements
BG0003
BG0013
BG0023
BG003
Mexico
ParticipantsBG00028
ParticipantsBG00128
ParticipantsBG00227
ParticipantsBG00327
ParticipantsBG004189
ParticipantsBG005184
ParticipantsBG006281
ParticipantsBG00720
ParticipantsBG008784
Title
Measurements
BG0000
BG0010
BG0020
BG003
28
ParticipantsBG00227
ParticipantsBG00327
ParticipantsBG004189
ParticipantsBG005184
ParticipantsBG006281
ParticipantsBG00720
ParticipantsBG008784
Title
Measurements
BG00090.0± 15.69
BG00189.3± 17.65
BG00286.1± 19.32
BG00383.4± 17.52
BG00484.7± 17.82
BG00586.8± 18.01
BG00685.3± 18.18
BG00779.1± 21.28
BG00885.6± 17.5
Odds Ratio (OR)
11.80
2-Sided
95
5.89
23.62
Superiority
11
Title
Denominators
Categories
Title
Measurements
OG000-40.44± 33.182
Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
OG002
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Units
Counts
Participants
OG000185
OG001180
OG002278
Title
Denominators
Categories
Title
Measurements
OG000-8.13± 3.100
OG001-31.23± 3.157
OG002-45.79± 2.663
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<0.001
Mean Difference (Final Values)
-23.10
Standard Error of the Mean
3.806
2-Sided
95
-30.57
-15.63
Superiority
OG000
OG002
ANCOVA
<0.001
Mean Difference (Final Values)
-37.65
Standard Error of the Mean
3.447
2-Sided
95
-44.24
-30.89
Superiority
OG002
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally every day QD, and one placebo tablet administered orally QD to maintain the blind.
Units
Counts
Participants
OG000189
OG001184
OG002281
Title
Denominators
Categories
Title
Measurements
OG0004.8(2.5 to 8.8)
OG0019.8(6.3 to 14.9)
OG00221.7(17.3 to 26.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.047
Odds Ratio (OR)
2.31
2-Sided
95
1.01
5.29
Superiority
OG000
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
6.03
2-Sided
95
2.91
12.51
Superiority
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally every day QD, and one placebo tablet administered orally QD to maintain the blind.
Units
Counts
Participants
OG000189
OG001184
OG002281
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and 95% confidence interval (CI) was not estimated due to insufficient number of participants with events.
OG001NA(NA to NA)Median and 95% confidence interval (CI) was not estimated due to insufficient number of participants with events.
OG002NA(NA to NA)Median and 95% confidence interval (CI) was not estimated due to insufficient number of participants with events.
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Units
Counts
Participants
OG000124
OG001136
OG002188
Title
Denominators
Categories
Title
Measurements
OG0003.2(1.3 to 8.0)
OG00119.1(13.4 to 26.5)
OG00231.4(25.2 to 38.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
<0.001
Odds Ratio (OR)
6.60
2-Sided
95
2.34
18.62
Superiority
OG000
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
13.58
2-Sided
95
5.01
36.81
Superiority
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Units
Counts
Participants
OG00096
OG001111
OG002167
Title
Denominators
Categories
Title
Measurements
OG0003.1(1.1 to 8.8)
OG00113.5(8.4 to 21.1)
OG00233.5(26.8 to 41.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.012
Odds Ratio (OR)
4.63
2-Sided
95
1.41
15.27
Superiority
OG000
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
14.42
2-Sided
95
4.73
43.93
Superiority
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Units
Counts
Participants
OG000181
OG001175
OG002275
Title
Denominators
Categories
Title
Measurements
OG0005.0(2.6 to 9.2)
OG00116.0(11.3 to 22.2)
OG00233.1(27.8 to 38.9)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
<0.001
Odds Ratio (OR)
3.92
2-Sided
95
1.81
8.51
Superiority
OG000
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
10.26
2-Sided
95
5.05
20.87
Superiority
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Units
Counts
Participants
OG000130
OG001141
OG002184
Title
Denominators
Categories
Title
Measurements
OG0003.1(1.2 to 7.6)
OG00116.3(11.1 to 23.3)
OG00232.1(25.7 to 39.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.001
Odds Ratio (OR)
5.58
2-Sided
95
1.97
15.83
Superiority
OG000
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
14.34
2-Sided
95
5.30
38.83
Superiority
Units
Counts
Participants
OG000100
OG001112
OG002161
Title
Denominators
Categories
Title
Measurements
OG0002.0(0.6 to 7.0)
OG00119.6(13.3 to 28.0)
OG00229.8(23.3 to 37.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
<0.001
Odds Ratio (OR)
10.34
2-Sided
95
2.72
39.30
Superiority
OG000
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
18.47
2-Sided
95
5.04
67.68
Superiority
OG002
4 mg Baricitinib Phase 3
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.
Units
Counts
Participants
OG000177
OG001174
OG002272
Title
Denominators
Categories
Title
Measurements
OG000-0.40± 0.234
OG001-1.22± 0.236
OG002-0.93± 0.199
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.005
Mean Difference (Final Values)
-0.82
Standard Error of the Mean
0.288
2-Sided
95
-1.38
-0.25
Superiority
OG000
OG002
ANCOVA
0.040
Mean Difference (Final Values)
-0.54
Standard Error of the Mean
0.261
2-Sided
95
-1.05
-0.02
Superiority
Participants received one 4 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain the blind.