Trials / Completed
CompletedNCT03570749
A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata
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
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 784 (actual)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Baricitinib | Administered orally. |
| DRUG | Placebo | Administered orally. |
Timeline
- Start date
- 2018-09-24
- Primary completion
- 2021-02-02
- Completion
- 2025-01-29
- First posted
- 2018-06-27
- Last updated
- 2026-04-16
- Results posted
- 2025-10-01
Locations
75 sites across 5 countries: United States, Japan, Mexico, Puerto Rico, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03570749. Inclusion in this directory is not an endorsement.