A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata

NCT03899259 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 16978I4V-MC-JAIR
• Study Type: interventional
• Target: 546
• Locations: 10 countries
• Sites: 96

Brief Summary

The reason for this study is to see if baricitinib is safe and effective in adults with severe or very severe alopecia areata (AA).

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20

  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

Secondary Outcomes (13)

• Percent Change From Baseline in SALT Score at Week 36

  Baseline, Week 36

• Percentage of Participants Achieving 50% Improvement of Severity of Alopecia Tool (SALT50)

  Week 12

• 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

  Week 36

• Time for Participants to Achieve SALT ≤ 20

  Week 52

• 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)

  Week 36

Study Arms (6)

4 Milligram (mg) Baricitinib

EXPERIMENTAL

Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.

Drug: Baricitinib; Drug: Placebo

2 mg Baricitinib

EXPERIMENTAL

Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.

Drug: Baricitinib; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participants received two placebo tablets administered orally QD to maintain the blind.

Drug: Placebo

4 mg Baricitinib Maximum Extended Enrollment (MEE)

EXPERIMENTAL

Participants received one 4 mg Baricitinib tablet administered orally, every day (QD) one placebo tablet administered orally QD to maintain blind.

Drug: Baricitinib; Drug: Placebo

2 mg Baricitinib MEE

EXPERIMENTAL

Participants received one 2 mg Baricitinib tablet administered orally QD, and one placebo tablet administered orally QD to maintain blind.

Drug: Baricitinib

Placebo MEE

PLACEBO COMPARATOR

Participants received two placebo tablets administered orally QD to maintain the blind.

Drug: Placebo

Interventions

Baricitinib DRUG

Administered orally

Also known as: LY3009104

2 mg Baricitinib; 2 mg Baricitinib MEE; 4 Milligram (mg) Baricitinib; 4 mg Baricitinib Maximum Extended Enrollment (MEE)

Placebo DRUG

Administered orally

2 mg Baricitinib; 4 Milligram (mg) Baricitinib; 4 mg Baricitinib Maximum Extended Enrollment (MEE); Placebo; Placebo MEE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent.
• 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 SALT (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. Note: participants who have severe or very severe AA for ≥8 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 8 years.
• Male or nonpregnant, nonbreastfeeding female participants.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Incyte Corporation: collaborator

Study Sites (96)

Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, 35205, United States

Location

Investigate MD

Scottsdale, Arizona, 85255, United States

Location

Center For Dermatology Clinical Research, Inc.

Fremont, California, 94538, United States

Location

Quest Dermatology Research

Northridge, California, 91324, United States

Location

Kaiser Permanente Hospital

San Francisco, California, 94118, United States

Location

New England Research Associates

Bridgeport, Connecticut, 06606, United States

Location

Florida Academic Centers Research and Education, LLC

Coral Gables, Florida, 33134, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613-1244, United States

Location

Dawes Fretzin Clinical Research Group, LLC

Indianapolis, Indiana, 46250, United States

Location

The South Bend Clinic Center for Research

South Bend, Indiana, 46617, United States

Location

Qualmedica Research, LLC

Owensboro, Kentucky, 42303, United States

Location

Dermatology and Skin Cancer Specialists

Rockville, Maryland, 20850, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

Location

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Associated Skin Care Specialists

New Brighton, Minnesota, 55112, United States

Location

MediSearch Clinical Trials

Saint Joseph, Missouri, 64506, United States

Location

Joseph J. Schwartz, M.D.

Troy, New York, 12180, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

Dermatology Specialists of Charlotte

Charlotte, North Carolina, 28211, United States

Location

M3-Emerging Medical Research

Raleigh, North Carolina, 27612, United States

Location

Bexley Dermatology Research

Bexley, Ohio, 43209, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Dermatologists of Southwest Ohio

Mason, Ohio, 45040, United States

Location

Vital Prospects Clinical Research Institute, P.C.

Tulsa, Oklahoma, 74136, United States

Location

Northwest Dermatology Institute

Portland, Oregon, 97210, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, 02818, United States

Location

Suzanne Bruce and Associates, PA

Houston, Texas, 77056, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

Stat Research

CABA, Buenos Aires, C1023AAB, Argentina

Location

Instituto de Neumonología y Dermatología

Capital Federal, Buenos Aires, 1425, Argentina

Location

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1027, Argentina

Location

Buenos Aires Skin

Buenos Aires, Buenos Aires F.D., 1055, Argentina

Location

Fundacion Respirar

Buenos Aires, Ciudad Autonoma Buenos Aires, C1426ABO, Argentina

Location

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina

Location

Parra Dermatología

Mendoza, 5500, Argentina

Location

Woden Dermatology

Phillip, Australian Capital Territory, 2606, Australia

Location

Skin & Cancer Foundation Australia

Westmead, New South Wales, 2045, Australia

Location

Veracity Clinical Research Pty Ltd

Woolloongabba, Queensland, 4102, Australia

Location

Clinical Trials SA Pty Ltd

Campbelltown, South Australia, 5073, Australia

Location

Skin Health Institute Inc.

Carlton, Victoria, 3053, Australia

Location

Sinclair Dermatology

Melbourne, Victoria, 3002, Australia

Location

Fremantle Dermatology

Fremantle, Western Australia, 6160, Australia

Location

IDERJ - Instituto de Dermatologia e Estética do Brasil

Rio de Janeiro, Rio de Janeiro, 22470-220, Brazil

Location

Irmandade da Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Centro de Pesquisa Sao Lucas

Campinas, São Paulo, 13034-685, Brazil

Location

Hospital de Clínicas Da Universidade Estadual de Campinas

Campinas, São Paulo, 13083-888, Brazil

Location

Faculdade de Medicina do ABC

Santo André, São Paulo, 09060-870, Brazil

Location

IBPClin - Instituto Brasil de Pesquisa Clínica

Rio de Janeiro, 22241-180, Brazil

Location

IPITEC

São Paulo, 01223-001, Brazil

Location

Servidor Público Estadual - IAMSPE - centro de estudos urológicos

São Paulo, 04039-901, Brazil

Location

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Beijing Friendship Hospital Affiliate of Capital University

Beijing, Beijing Municipality, 100050, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Guangdong Province Dermatology Hospital

Guangzhou, Guangdong, 510018, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212000, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710004, China

Location

HuaShan Hospital Affiliated To Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, 200071, China

Location

First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, 30001, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

Location

Rabin Medical Center

Petah Tikva, Central District, 4941492, Israel

Location

Sheba Medical Center

Ramat Gan, Central District, 5262100, Israel

Location

Hadassah Medical Center

Jerusalem, Jerusalem, 9112001, Israel

Location

Emek Medical Center

Afula, Northern District, 1834111, Israel

Location

Rambam Medical Center

Haifa, Northern District, 3109601, Israel

Location

Soroka Medical Center

Beersheba, Southern District, 8410101, Israel

Location

Sourasky Medical Center

Tel Aviv, Tell Abīb, 6423906, Israel

Location

Yokohama Rosai Hospital

Yokohama, Kanagawa, 222-0036, Japan

Location

Hamamatsu University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Juntendo Tokyo Koto Geriatric Medical Center

Koto-ku, Tokyo, 136-0075, Japan

Location

Kyorin University Hospital

Mitaka, Tokyo, 181-8611, Japan

Location

Tokyo Medical Univ. Hospital

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Yamaguchi University Hospital

Ube, Yamaguchi, 755-8505, Japan

Location

Osaka City University Hospital

Osaka, 545-8586, Japan

Location

Clinical Research Puerto Rico

San Juan, 00909, Puerto Rico

Location

Dankook University Hospital

Cheonan, Chungcheongnam-do, 31116, South Korea

Location

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 14584, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Boramae Medical Center

Dongjak-gu, Seoul-teukbyeolsi [Seoul], 07061, South Korea

Location

Kyunghee University Hospital at Gangdong

Seoul, Seoul-teukbyeolsi [Seoul], 134-090, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Chung Shan Medical University Hospital

Taichung, Taichung, 402, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch

Taoyuan District, 333, Taiwan

Location

Related Publications (8)

• 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.

  PMID: 40214720 DERIVED

• 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.

  PMID: 38904749 DERIVED

• 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.

  PMID: 37991697 DERIVED

• 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.

  PMID: 37556146 DERIVED

• 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.

  PMID: 37381691 DERIVED

• 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.

  PMID: 36855020 DERIVED

• 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.

  PMID: 36763878 DERIVED

• 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.

  PMID: 35334197 DERIVED

Related Links

• A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata

MeSH Terms

Conditions

Alopecia Areata

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-595-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 2, 2019
• Study Start: July 8, 2019
• Primary Completion: January 24, 2021
• Study Completion: November 19, 2024
• Last Updated: January 31, 2025
• Results First Posted: May 14, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

CN (15); IL (7); AR (7); AU (7); US (33); BR (8); KR (6); PR (1); TW (4); JP (8)