Alopecia AreataPhase 2/3BRAVE-AA1NCT03570749
A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata
A Phase 2/3 study testing Baricitinib in people with Alopecia Areata, run by Eli Lilly and Company at 75 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alopecia Areata
- What is being tested?
- Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 784 participants
- Where
- 75 sitesin 5 countries
- Study dates
- 24 Sep 2018to 29 Jan 2025
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
75 sites in 5 countries.
75 sites in 5 countries
United States50 sites
Bellaire Dermatology
Bellaire, Texas, 77401
ActivMed Practices and Research
Beverly, Massachusetts, 01915
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
Clarkston Skin Research
Clarkston, Michigan, 48346
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Modern Research Associates
Dallas, Texas, 75231
California Dermatology & Clinical Research Institute
Encinitas, California, 92024
Dermatology and Skin Surgery Center
Exton, Pennsylvania, 19341
Johnson Dermatology
Fort Smith, Arkansas, 72916
OH State Univ College of Med
Gahanna, Ohio, 43230
Callender Center for Clinical Research, LLC / Research
Glenn Dale, Maryland, 20769
Penn State Univ. Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Center for Clinical Studies
Houston, Texas, 77004
Alliance Research Centers
Irvine, California, 92612
University of CA, Irvine
Irvine, California, 92617
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, 32256
Dermatology Research Associates
Los Angeles, California, 90045
Forefront Research
Louisville, Kentucky, 40241
Skin Care Physicians of Georgia
Macon, Georgia, 31217
University of Miami
Miami, Florida, 33125
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
Coastal Clinical Research, Inc
Mobile, Alabama, 36608
University of Utah MidValley Dematology
Murray, Utah, 84107
Yale University School of Medicine
New Haven, Connecticut, 06519
Medaphase Inc
Newnan, Georgia, 30263
Park Avenue Dermatology
Orange Park, Florida, 32073
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Dermatology Associates of Plymouth Meeting
Plymouth Meeting, Pennsylvania, 19462
NW Dermatology & Research Center, LLC
Portland, Oregon, 97210
Oregon Medical Research Center
Portland, Oregon, 97223
OHSU Center for Health and Healing
Portland, Oregon, 97239
ActivMed Practices and Research
Portsmouth, New Hampshire, 03801
Stanford Health Care
Redwood City, California, 94063
University of Rochester School of Medicine
Rochester, New York, 14642
University of California Davis-Dermatology
Sacramento, California, 95816
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
University Clinical Trials, Inc.
San Diego, California, 92123
Mosaic Dermatology
Santa Monica, California, 90403
Dermatology Associates
Seattle, Washington, 98101
ForCare Clinical Research
Tampa, Florida, 33613-1244
Montefiore Medical Center
The Bronx, New York, 10467-2490
Center for Clinical Studies
Webster, Texas, 77598
South Korea11 sites
Pusan National University Hospital
Busan, Korea, 49241
Kyung Pook National University Hospital
Daegu, Korea, 41944
Chungnam National University Hospital
Daejeon, Korea, 35015
Chonbuk National University Hospital
Jeonju, Jeon Ra Buk-Do, Korea, 54907
Inha University Hospital
Jung-gu, Incheon, 22332
Seoul National University Bundang Hospital
Seongnam, Geonggi-do, 13620
Seoul National University Hospital
Seoul, 03080
Eunpyeong St. Mary's Hospital
Seoul, 03312
Konkuk University Medical Center
Seoul, 05030
Kyunghee University Hospital at Gangdong
Seoul, 05278
Chungang University Hospital
Seoul, 06973
Mexico8 sites
Derma Norte del Bajío, S.C.
Aguascalientes
RM Pharma Specialists S.A. de C.V.
Distrito Federal, 3100
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango, 34000
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Jalisco, 44650
Consultorio Privado de la Dra. Villanueva
Guadalajara, Jalisco, 44657
B&B Investigaciones Medicas, SC
Mazatlán, Sinaloa, 82140
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, N.L., 64460
CRI Centro Regiomontano de Investigacion S.C.
Monterrey, Nuevo León, 64060
Japan4 sites
Hamamatsu University School of Medicine, University Hospital
Hamamatsu, Shizuoka, 431-3192
Kurume University Hospital
Kurume, Fukuoka, 830 0011
Osaka City University Hospital
Osaka, 545-8586
Tokyo Medical Univ. Hospital
Shinjuku-ku, Tokyo, 160-0023
Puerto Rico2 sites
Ponce School of Medicine CAIMED Center
Ponce, PR, 00716
GCM Medical Group, PSC- Hato Rey
San Juan, PR, 00917
About this study
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
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.
- Conditions
- Alopecia Areata
- Being tested
- Baricitinib, Placebo
- Medical subject headings
- Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Also called LY3009104
Administered orally.
PlaceboDrug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Baricitinib |
| Placebo Phase 3 | 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Baricitinib |
| 4 mg Baricitinib Phase 3 Open-Label Addendum | Experimental | Participants who received one 4 mg Baricitinib tablet administered orally QD. Receives: Drug: Baricitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, Week 52
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start24 Sep 2018
- Primary completion2 Feb 2021
- Study completion29 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 784 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Incyte Corporation
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570749
- Sponsor's protocol ID
- 16582
- Other IDs
- I4V-MC-JAHO
- Acronym
- BRAVE-AA1
- Status last verified
- Mar 2026
- First submitted
- 18 Jun 2018
- Last updated
- 16 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Vleugels RA, Piraccini BM, Mesinkovska N, Mostaghimi A, Shimomura Y, Sontag A, McSwiney F, Somani N, Pandey H, Denning K, King B. Baricitinib Efficacy Through 4 Years in Responders and Safety up to 5 Years in Adults with Severe Alopecia Areata: Final Results from BRAVE-AA1 and BRAVE-AA2. Dermatol Ther (Heidelb). 2026 Oct 2. doi: 10.1007/s13555-026-01886-9. Online ahead of print.
PubMed 42825995King 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.
PubMed 40214720King 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.
PubMed 39141364Craiglow 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.
PubMed 38904749Senna 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.
PubMed 37991697Ko 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.
PubMed 37556146Piraccini 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.
PubMed 37381691Kwon 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.
PubMed 36855020King 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.
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