A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata (BRAVE-AA1)
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
Sponsor: Eli Lilly and Company
Listed as NCT03570749, this observational or N/A phase trial focuses on Alopecia Areata and remains completed. Sponsored by Eli Lilly and Company, it has been updated 49 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
49 versions recorded-
Apr 17, 2026 — Present [daily]
Completed
Phase: PHASE2/PHASE3 → None
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Nov 2025 — Apr 2026 [monthly]
Completed PHASE2/PHASE3
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Sep 2025 — Nov 2025 [monthly]
Completed PHASE2/PHASE3
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May 2025 — Sep 2025 [monthly]
Completed PHASE2/PHASE3
Status: Active Not Recruiting → Completed
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Feb 2025 — May 2025 [monthly]
Active Not Recruiting PHASE2/PHASE3
▶ Show 44 earlier versions
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Oct 2024 — Feb 2025 [monthly]
Active Not Recruiting PHASE2/PHASE3
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Sep 2024 — Oct 2024 [monthly]
Active Not Recruiting PHASE2/PHASE3
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE2/PHASE3
Phase: PHASE2_PHASE3 → PHASE2/PHASE3
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Jun 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE2_PHASE3
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May 2024 — Jun 2024 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Apr 2024 — May 2024 [monthly]
Active Not Recruiting PHASE2_PHASE3
Status: Recruiting → Active Not Recruiting
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Nov 2023 — Apr 2024 [monthly]
Recruiting PHASE2_PHASE3
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Sep 2023 — Nov 2023 [monthly]
Recruiting PHASE2_PHASE3
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Aug 2023 — Sep 2023 [monthly]
Recruiting PHASE2_PHASE3
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Jun 2023 — Aug 2023 [monthly]
Recruiting PHASE2_PHASE3
Status: Active Not Recruiting → Recruiting
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Apr 2023 — Jun 2023 [monthly]
Active Not Recruiting PHASE2_PHASE3
Status: Recruiting → Active Not Recruiting
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Mar 2023 — Apr 2023 [monthly]
Recruiting PHASE2_PHASE3
Status: Active Not Recruiting → Recruiting
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Apr 2022 — Mar 2023 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Mar 2021 — Apr 2022 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Feb 2021 — Mar 2021 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Jan 2021 — Feb 2021 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Dec 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Nov 2020 — Dec 2020 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Oct 2020 — Nov 2020 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Sep 2020 — Oct 2020 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Aug 2020 — Sep 2020 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Jul 2020 — Aug 2020 [monthly]
Active Not Recruiting PHASE2_PHASE3
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Jun 2020 — Jul 2020 [monthly]
Active Not Recruiting PHASE2_PHASE3
Status: Recruiting → Active Not Recruiting
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May 2020 — Jun 2020 [monthly]
Recruiting PHASE2_PHASE3
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Apr 2020 — May 2020 [monthly]
Recruiting PHASE2_PHASE3
Status: Active Not Recruiting → Recruiting
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Mar 2020 — Apr 2020 [monthly]
Active Not Recruiting PHASE2_PHASE3
Status: Recruiting → Active Not Recruiting
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Jan 2020 — Mar 2020 [monthly]
Recruiting PHASE2_PHASE3
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Dec 2019 — Jan 2020 [monthly]
Recruiting PHASE2_PHASE3
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Nov 2019 — Dec 2019 [monthly]
Recruiting PHASE2_PHASE3
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Oct 2019 — Nov 2019 [monthly]
Recruiting PHASE2_PHASE3
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Sep 2019 — Oct 2019 [monthly]
Recruiting PHASE2_PHASE3
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Aug 2019 — Sep 2019 [monthly]
Recruiting PHASE2_PHASE3
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Jul 2019 — Aug 2019 [monthly]
Recruiting PHASE2_PHASE3
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Jun 2019 — Jul 2019 [monthly]
Recruiting PHASE2_PHASE3
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May 2019 — Jun 2019 [monthly]
Recruiting PHASE2_PHASE3
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Apr 2019 — May 2019 [monthly]
Recruiting PHASE2_PHASE3
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Mar 2019 — Apr 2019 [monthly]
Recruiting PHASE2_PHASE3
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Feb 2019 — Mar 2019 [monthly]
Recruiting PHASE2_PHASE3
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Jan 2019 — Feb 2019 [monthly]
Recruiting PHASE2_PHASE3
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Dec 2018 — Jan 2019 [monthly]
Recruiting PHASE2_PHASE3
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Nov 2018 — Dec 2018 [monthly]
Recruiting PHASE2_PHASE3
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Oct 2018 — Nov 2018 [monthly]
Recruiting PHASE2_PHASE3
Status: Not Yet Recruiting → Recruiting
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Sep 2018 — Oct 2018 [monthly]
Not Yet Recruiting PHASE2_PHASE3
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Jul 2018 — Sep 2018 [monthly]
Not Yet Recruiting PHASE2_PHASE3
First recorded
Eligibility 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.
Contact Information
- Eli Lilly and Company
- Incyte Corporation
For direct contact, visit the study record on ClinicalTrials.gov .