NCT07049575RecruitingPhase 1
A Maximal Use Trial of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Incyte Corporation
- Enrollment
- 24
- Locations
- 21
- Primary Endpoint
- Number of participants with Treatment-emergent Adverse Events (TEAEs)
Study Overview
Brief Summary
The purpose of this study is to evaluate the maximal use of ruxolitinib cream in adult and adolescent participants with hidradenitis suppurativa.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of HS for at least 6 months before screening visit.
- •Diagnosis of HS (Hurley Stage I, II, III) with a total abscess and inflammatory nodule count of at least 4 and affecting at least 3 distinct anatomical areas at screening and Day 1 visits.
- •Total estimated treatment BSA > 20% at screening and baseline.
- •Agreement to not use topical or systemic antibiotics for treatment of HS during the Maximal Use Treatment Period.
- •Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol.
- •Further inclusion criteria apply.
Exclusion Criteria
- •Current or history of skin condition(s) other than HS that might confound the evaluation of HS; clinically uncontrolled cardiovascular disease; thrombosis; certain cancers; certain infections; severe anemia, thrombocytopenia, or neutropenia; other medical conditions at the discretion of the investigator.
- •Laboratory values outside of the protocol-defined ranges.
- •Further exclusion criteria apply.
Arms & Interventions
Ruxolitinib 1.5 % Cream
Experimental
Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
Intervention: Ruxolitinib Cream (Drug)
Outcomes
Primary Outcomes
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 24 weeks
Defined as adverse events reported for the first time or worsening of a pre-existing event after the first application of study drug.
Number of participants with TEAEs leading to treatment interruption, discontinuation
Time Frame: Up to 24 weeks
Number of participants with TEAEs leading to dose interruption or discontinuation
Secondary Outcomes
- Pharmacokinetics Parameter (PK): Cmax of INCB018424(Up to 24 weeks)
- Pharmacokinetics Parameter: Tmax of INCB018424(Up to 24 weeks)
- Pharmacokinetics Parameter: AUC 0-12 of INCB018424(Up to 24 weeks)
Investigators
Study Sites (21)
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