Brepocitinib treatment for adults with lichen planopilaris
A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Lichen Planopilaris
This trial will test whether an oral medicine called brepocitinib can safely reduce scalp inflammation and symptoms in adults with lichen planopilaris.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 342 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Priovant Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | brepocitinib |
| Locations | 5 sites (Phoenix, Arizona and 4 other locations) |
| Trial ID | NCT07532603 on ClinicalTrials.gov |
What this trial studies
This Phase 2/3 randomized, placebo-controlled study gives eligible adults with biopsy-confirmed, active lichen planopilaris oral brepocitinib or placebo to measure clinical safety and symptom improvement. Participants must have active, symptomatic scalp disease at screening and meet weight/BMI limits, and will be followed over the treatment period with regular clinic visits. Key exclusions include recent or active malignancy, high risk of thrombosis or herpes zoster, and active or recent infections. The trial aims to compare efficacy outcomes and adverse events between brepocitinib and placebo groups to determine whether the drug provides measurable benefit.
Who should consider this trial
Good fit: Adults aged 18 or older with a scalp biopsy consistent with lichen planopilaris, active symptomatic disease at screening, and within the specified weight/BMI range who do not have excluded high-risk conditions are ideal candidates.
Not a fit: People with a history of recent cancer, active infection, high risk of thrombosis or herpes zoster, or those outside the weight/BMI limits are unlikely to be eligible or benefit from participation.
Why it matters
Potential benefit: If successful, brepocitinib could reduce scalp inflammation and hair loss and offer a new effective oral option for adults with lichen planopilaris.
How similar studies have performed: Oral JAK/TYK2 pathway inhibitors have shown positive results in some related inflammatory hair disorders, but using brepocitinib specifically for lichen planopilaris is relatively new and still being tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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: 1. 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
Where this trial is running
Phoenix, Arizona and 4 other locations
- Clinical Trial Site — Phoenix, Arizona, United States (Recruiting)
- Clinical Trial Site — Portland, Oregon, United States (Recruiting)
- Clinical Trial Site — Smyrna, Tennessee, United States (Recruiting)
- Clinical Trial Site — Austin, Texas, United States (Recruiting)
- Clinical Trial Site — Cedar Park, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trial Administrator
- Email: clinicaltrials@priovant.com
- Phone: (212) 634-9743
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.