A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata (BRAVE-AA1)
A Study of Baricitinib (LY3009104) in Participants With Severe or Very Severe Alopecia Areata (BRAVE-AA1)
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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 824 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date: October 30, 2018
Actual Primary Completion Date: February 2, 2021
Estimated Study Completion Date: June 24, 2024
Arm:
- Experimental: Baricitinib High Dose
- Experimental: Baricitinib Low Dose
- Placebo Comparator: Placebo
- Experimental: Open-Label Addenda Baricitinib High Dose
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 824 |
| Actual Study start date | 30 October 2018 |
| Estimated Study Completion Date | 24 June 2024 |