Recruiting NCT07532603
A Phase 2/3 Study of Brepocitinib in Adults With Lichen Planopilaris
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oral Brepocitinib, Placebo.
- Who it may be relevant to
- Registry conditions: Lichen Planopilaris. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with lichen planopilaris
Interventions
- Drug Oral Brepocitinib
Oral - Drug Placebo
Oral
Primary outcome measures
- Proportion of participants achieving IGA score 0/1 and ≥ 2-step reduction from baseline at Week 24 [Time frame: Week 24]
Secondary outcome measures (1)
- Change from baseline in LPP symptom numerical rating scale scores at Week 24 [Time frame: Week 24]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Scalp biopsy consistent with LPP
- Active and symptomatic LPP at screening and baseline-
- 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).
- High risk of thrombosis or cardiovascular disease
- High risk of herpes zoster
- Active or recent infection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 47 centers
- Clinical Trial Site — Birmingham
- Clinical Trial Site — Phoenix
- Clinical Trial Site — Scottsdale
- Clinical Trial Site — Irvine
- Clinical Trial Site — Oakland
- Clinical Trial Site — Sacramento
- Clinical Trial Site — San Francisco
- Clinical Trial Site — Denver
- … and 39 more centers
United Kingdom · 6 centers
- Clinical Trial Site — Salford
- Clinical Trial Site — Glasgow
- Clinical Trial Site — Brighton
- Clinical Trial Site — London
- Clinical Trial Site — London
- Clinical Trial Site — Wrexham
Canada · 5 centers
- Clinical Trial Site — Edmonton
- Clinical Trial Site — Guelph
- Clinical Trial Site — London
- Clinical Trial Site — Toronto
- Clinical Trial Site — Toronto
Australia · 3 centers
- Clinical Trial Site — Adelaide
- Clinical Trial Site — Perth
- Clinical Trial Site — Sydney
Identifiers
NCT: NCT07532603 · PVT-2201-304