Actively Recruiting
A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Lichen Planopilaris
Led by Priovant Therapeutics, Inc. · Updated on 2026-04-16
342
Participants Needed
5
Research Sites
30 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of oral brepocitinib in adults with lichen planopilaris, a condition affecting the scalp. This Phase 2/3 randomized, double-blind, placebo-controlled study aims to understand how well this drug works compared to a placebo in improving symptoms of this condition. The trial is sponsored by Priovant Therapeutics, Inc. and focuses on finding treatments that may help reduce disease activity and symptoms. Participants will be randomly assigned to receive either oral brepocitinib or a placebo. The study will monitor their progress over 24 weeks, measuring changes using the Investigator's Global Assessment (IGA) score and symptom rating scales. The trial includes a treatment period where participants take the oral medication and are regularly assessed for response and safety. Throughout the study, participants will have clinical evaluations to track their scalp condition and symptom changes. The main outcome measured is the proportion of participants achieving a significant improvement in IGA score by week 24. Secondary outcomes include changes in symptom severity. Safety will be closely monitored, and the total duration of participation will cover the treatment and follow-up periods up to week 24.
CONDITIONS
Brief Title
A Phase 2/3 Study of Brepocitinib in Adults With Lichen Planopilaris
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scalp biopsy consistent with lichen planopilaris
- Active and symptomatic lichen planopilaris at screening and baseline
- Weight between 40 kg and 130 kg with BMI of 45 kg/m2 or less
You will not qualify if you...
- History of lymphoproliferative disorder
- History of active malignancy or cancer within 5 years prior to baseline (exceptions apply for certain skin, breast, cervical, or thyroid cancers)
- High risk of thrombosis or cardiovascular disease
- High risk of herpes zoster
- Active or recent infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive oral Brepocitinib or placebo as part of the study treatment.
Regular visits during treatment (exact schedule not specified)
Trial Site Locations
Total: 5 locations
1
Clinical Trial Site
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Clinical Trial Site
Portland, Oregon, United States, 97210
Actively Recruiting
3
Clinical Trial Site
Smyrna, Tennessee, United States, 37167
Actively Recruiting
4
Clinical Trial Site
Austin, Texas, United States, 78613
Actively Recruiting
5
Clinical Trial Site
Cedar Park, Texas, United States, 78613
Actively Recruiting
Research Team
C
Clinical Trial Administrator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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