Lichen Planopilaris
Conditions
Keywords
brepocitinib, lichen planopilaris
Brief summary
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with lichen planopilaris
Interventions
Oral
DRUGPlacebo
Oral
Sponsors
Priovant Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving IGA score 0/1 and ≥ 2-step reduction from baseline at Week 24 | Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in LPP symptom numerical rating scale scores at Week 24 | Week 24 |
Countries
Australia, Canada, United Kingdom, United States
Contacts
CONTACTClinical Trial Administrator
Outcome results
None listed