drugset / Trial / NCT03899259
A Study of Baricitinib (LY3009104) in Adults With Severe or Very Severe Alopecia Areata
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2019-07-08
- Primary completion
- 2021-01-24
- Completion
- 2024-11-19
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs 2 mg Baricitinib; p <0.001; Odds Ratio (OR) 7.86 (95% CI 2.79 to 22.17); Regression, Logistic NCT03899259 ↗
registry analysis (superiority test); Placebo vs 4 mg Baricitinib; p <0.001; Odds Ratio (OR) 19.72 (95% CI 7.30 to 53.30); Regression, Logistic NCT03899259 ↗
release “Both doses of baricitinib met the primary efficacy endpoint at Week 36” incyte.com ↗
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Baricitinib | Small molecule | 2 mg | Oral |
| Subject | Baricitinib | Small molecule | 4 mg | Oral |