A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Cutaneous Sarcoidosis (NCT06978725)

This is a 16-week double blind study to evaluate the safety and effectiveness of an oral investigational study drug in adults with cutaneous sarcoidosis (CS), a condition where inflammatory disease affects the skin. Eligible participants will be randomly assigned to receive the study drug or placebo for 16 weeks. After this period, all participants will receive the study drug for 36 weeks. What is involved? A screening period of up to 30 days to check eligibility; A 16-week treatment period where participants receive either the study drug or placebo; A 36-week open-label extension period where all participants receive the study drug; A 4-week safety follow-up after treatment ends; Regular clinic visits for safety checks and physical assessments; Possible tapering of oral corticosteroids during the study, if applicable; Blood and urine tests to monitor safety and treatment response; Completion of questionnaires and clinical assessments related to skin disease and quality of life.

Trial phase

Phase 2

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Johannes S Kern

Key inclusion data

Adults ≥18 years of age; Diagnosed with active cutaneous sarcoidosis affecting the skin; Meet study-specific disease severity criteria as assessed by the study doctor; Otherwise generally healthy or with stable medical conditions as determined by the study doctor. Please note, other eligibility criteria may apply.