A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled 16-Week Study Evaluating the Safety and Efficacy of Ritlecitinib in Adults With Moderate to Severe Hidradenitis Suppurativa

What this Trial Is About

Researchers are studying the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa HS, a condition causing long-lasting painful red skin lumps. The study focuses on participants who have not responded well to antibiotics or could not tolerate them. This is a phase 2, randomized, double-blind, placebo-controlled trial to evaluate how well Ritlecitinib works compared to a placebo. Participants will be randomly assigned to receive either Ritlecitinib or a placebo pill that looks the same but contains no medicine. Those in the treatment group will take an oral loading dose once daily for 8 weeks, followed by a maintenance dose once daily for another 8 weeks. The placebo group will receive matching placebo pills on the same schedule. The total study duration is about 16 weeks. During the study, participants will attend about 10 clinic visits including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until week 16. At each visit, health status will be checked through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also use an electronic diary on their mobile phones to record daily medication intake and HS symptoms. The main measurement is the proportion of participants achieving a 50 reduction in HS symptoms by week 16. Safety and other symptom improvements will also be monitored.

A 16-Week Study to Learn About the Study Medicine Called Ritlecitinib in Adults With Long Lasting Painful Red Skin Lumps, Known by the Medical Term, Hidradenitis Suppurativa, or HS.