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

  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

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

ArmDescriptionAssigned Intervention
Experimental
Brepocitinib Dose Level 1
  • Drug: Oral Brepocitinib
    Oral
Placebo Comparator
Placebo
  • Drug: Placebo
    Oral

Recruiting Locations

Clinical Trial Site
Phoenix, Arizona 85006

Clinical Trial Site
Portland, Oregon 97210

Clinical Trial Site
Smyrna, Tennessee 37167

Clinical Trial Site
Austin, Texas 78613

Clinical Trial Site
Cedar Park, Texas 78613

More Details

Status
Recruiting
Sponsor
Priovant Therapeutics, Inc.

Study Contact

Clinical Trial Administrator
(212) 634-9743
clinicaltrials@priovant.com