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

This is a prospective, randomized, double-blind, placebo-controlled, dose-ranging study. The population selected for this study comprises individuals with active cutaneous sarcoidosis. After an up to 30-day Screening Period, eligible participants will be centrally randomized 3:2:2 to 1 of 3 intervention groups to receive blinded investigational medicinal product (IMP) of either brepocitinib 45 mg, brepocitinib 15 mg, or matching placebo, administered orally (PO) once daily (QD). The purpose of this study is to measure clinical safety and efficacy of oral brepocitinib in adult participants with cutaneous sarcoidosis. Study details include: ? Up to 30 days for screening (Screening Period), then ? 16 weeks of treatment with double-blinded treatment with either brepocitinib 45 mg, brepocitinib 15 mg, or placebo (Treatment Period) QD, then ? 4 weeks for safety follow-up (Off-Drug Follow-Up Period) ? The visit frequency is every 4 weeks. Ongoing standard of care (that meets eligibility criteria requirements) will be maintained during the Treatment Period. Participants who are receiving ongoing oral corticosteroids at baseline will undergo a mandatory taper (starting with Day 15, Week 2) and discontinue oral corticosteroids on or before Day 57 (Week 8). Approximately 28 participants at up to approximately 20 sites in the US.

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