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A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa Topical Ruxolitinib Evaluation in Hidradenitis Suppurativa (TRuE-HS1)
Status: Recruiting
Hidradenitis Suppurativa (HS) is a chronic condition that causes bumps or boils, often in the folds of armpits, chest, breasts, groin, stomach, back or sides, or buttocks. This Study is being done to compare the safety and effectiveness of a Study Drug called ruxolitinib cream with a vehicle cream for people with hidradenitis suppurative. A vehicle cream looks like the Study Cream but does not have active drug in it. Participants will be in the Study for approximately 60 weeks. This includes a 28-day screening period, 16 weeks of receiving either the Study Cream or vehicle cream, 36 weeks of receiving the Study Cream, and a 30-day follow-up.
Sex: Male or Female
Age Group: Not specified
Inclusion Criteria:
• diagnosis of Hidradenitis Suppurativa (HS) at least 6 months before starting the study
• see link to clincialtrials.gov for complete inclusion criteria
Exclusion Criteria:
• people who have cancer
• women who are pregnant or breastfeeding
• see link to clincialtrials.gov for complete exclusion criteria
Conditions:
Dermatology (Skin, Hair & Nails)
Keywords:
Hidradenitis Suppurativa, HS1
Study Contact: Jaime Nugent - speck007@umn.edu
Principal Investigator: Noah Goldfarb
Phase: PHASE3
IRB Number: STUDY00025137
See this study on ClinicalTrials.gov