Phase 3 trial of Brepocitinib in Adults with Lichen Planopilaris
Research type
Research Study
Full title
A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Lichen Planopilaris
IRAS ID
1013434
Contact name
Sandra Umbrecht
Contact email
Sponsor organisation
Priovant Therapeutics, Inc.
Research summary
The aim of this study is to investigate the safety and efficacy of oral Brepocitinib in adults with Lichen Planopilaris (LPP).
LPP is a skin condition, which affects areas of skin where there is hair, it destroys the hair follicle and then replaces it with scarring, resulting in permanent hair loss. The cause of LPP is unknown. LPP may be managed with prescription creams, shampoos, gels, or oral tablets, but results vary widely from person to person. No single treatment has been proven fully effective, and some individuals may not respond to any therapy at all.
There is a need for approved treatments for LPP based on randomised clinical trials. This will be the first Phase 2/3 trial in LPP, evaluating brepocitinib, which may improve disease signs and symptoms, reduce corticosteroid use, and offer an option for patients unresponsive or intolerant to other therapies.
This study is divided into two separate parts: a Phase 2 study and a Phase 3 study. In both phases, participants with moderate to severe, lab-confirmed LPP eligible for systemic therapy will be randomly assigned, following a screening period to either brepocitinib or placebo for 24 weeks, without knowing (double-blind) which treatment they receive. After this period, all participants receive brepocitinib for another 28 weeks in an open-label (OLE) extension, followed by a 4-week safety follow up. Visits occur every 4 weeks during the blinded phase and every 4–8 weeks in OLE.
The studies are identical except for the number of participants and the active/placebo assignment ratio. Approximately 342 participants (72 in Phase 2, 270 in Phase 3) will be randomised across 120 global sites, with 6 sites in the UK.
Following participant consent, assessments include questionnaires, ECG, blood tests, physical exams, Hair Pull Test, skin biopsy (if needed), trichoscopy and scalp photography.
An Independent Data Monitoring Committee will oversee study progress and safety as outlined in its charter.REC name
South Central - Oxford A Research Ethics Committee
REC reference
26/SC/0047
Date of REC Opinion
9 Mar 2026
REC opinion
Further Information Favourable Opinion