A Phase 2/3 Study of Brepocitinib in Adults With Lichen Planopilaris
Purpose
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with lichen planopilaris
Condition
- Lichen Planopilaris
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥ 18 years 2. Scalp biopsy consistent with LPP 3. Active and symptomatic LPP at screening and baseline- 4. Weight > 40 kg to < 130 kg with BMI ≤ 45 kg/m2
Exclusion Criteria
- History of: Lymphoproliferative disorder; Active malignancy; History of cancer within 5 years prior to baseline (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid cancer). 2. High risk of thrombosis or cardiovascular disease 3. High risk of herpes zoster 4. Active or recent infection
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Brepocitinib Dose Level 1 |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Clinical Trial Site
Phoenix, Arizona 85006
Phoenix, Arizona 85006
Clinical Trial Site
Portland, Oregon 97210
Portland, Oregon 97210
Clinical Trial Site
Smyrna, Tennessee 37167
Smyrna, Tennessee 37167
Clinical Trial Site
Austin, Texas 78613
Austin, Texas 78613
Clinical Trial Site
Cedar Park, Texas 78613
Cedar Park, Texas 78613
More Details
- Status
- Recruiting
- Sponsor
- Priovant Therapeutics, Inc.