Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Incyte Corporation
- Study ID
- NCT06958211
- Phase
- PHASE3
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ruxolitinib Cream — DRUGRuxolitinib cream applied topically to the affected area as a thin film twice daily.
- Vehicle Cream — DRUGMatching vehicle cream applied topically to the affected area as a thin film twice daily.
Study Details
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.
Key Dates
- Start date
- Jun 12, 2025
- Status verified
- Apr 2026
- Primary completion
- Oct 9, 2026
- Completion
- Jul 11, 2027
Study Design
- Enrollment
- 550 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Ruxolitinib 1.5 % CreamParticipants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
- Placebo Comparator: Vehicle CreamParticipants received vehicle cream, applied topically to the affected area as defined by the protocol.
Primary Outcome Measure
Proportion of participants who achieve Hidradenitis Suppurativa (HS) Clinical Response 75 (HiSCR75) from baseline [ Time Frame: Week 16 ]
Central Contacts
- Incyte Corporation Call Center (US)1.855.463.3463
- Incyte Corporation Call Center (ex-US)+800 00027423
Locations (67)
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