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 BRAVE-AA1
Recruiting
99 years or below
All
Phase
3
10 participants needed
1 Location
Brief description of study
To evaluate the effectiveness of 4-mg baricitinib in significant increase in hair regrowth in patients with severe AA
To describe the effectiveness of 4-mg baricitinib in achieving regrowth as assessed by physician assessed signs and symptoms of AA Mean percentage change from baseline to Week 52 in SALT score. Proportion of patients achieving SALT 20 from baseline through Week 52
Proportion of patients achieving a SALT50, SALT75, and SALT90 from baseline through Week 52
Percentage change from baseline in SALT score at Week 36
Mean change from baseline in SALT through Week 52
Proportion of patients achieving ClinRO Measure for EB Hair Loss 0 or 1 with 2-point improvement from Baseline through Week 52 (among patients with ClinRO Measure for EB Hair Loss 2 at Baseline)
Proportion of patients achieving ClinRO Measure for EL Hair Loss 0 or 1 with 2-point improvement from Baseline through Week 52 (among patients with ClinRO Measure for EL Hair Loss 2 at Baseline
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
-
Age: 99 years or below
-
Gender: All
Updated on
14 Jun 2023.
Study ID: 853375
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