A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Cutaneous Sarcoidosis
Priovant Therapeutics, Inc.
Summary
This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults subjects (18-74) 2. Cutaneous sarcoidosis with characteristic skin biopsy histology 3. A CSAMI activity score ≥ 10 4. Weight \> 40 kg to \< 130 kg with BMI \< 40 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, or carcinoma in situ of the uterine cervix). 2. High risk of thrombosis or cardiovascular disease 3. High risk of herpes zoster 4. Active or recent infection
Interventions
- DrugOral Brepocitinib
Drug: Oral Brepocitinib
- DrugOral Placebo
Drug: Oral Placebo
Locations (4)
- Clinical Trial SiteSan Francisco, California
- Clinical Trial SiteDurham, North Carolina
- Clinical Trial SitePhiladelphia, Pennsylvania
- Clinical Trial SiteMadison, Wisconsin