Study to Evaluate the Maximal Use of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa

Not Applicable

Not yet recruiting

• Conditions: Hidradenitis Suppurativa

• Registration Number: NCT07049575
• Lead Sponsor: Incyte Corporation

Brief Summary

The purpose of this study is to evaluate the maximal use of ruxolitinib cream in adult and adolescent participants with hidradenitis suppurativa.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-25
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-07-03
• Last Update Posted: 2025-07-03
• Study Start: 2025-09-15
• Primary Completion: 2026-12-09
• Study Completion: 2026-12-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants with Treatment-emergent Adverse Events (TEAEs)	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	Up to 24 weeks	Number of participants with TEAEs leading to dose interruption or discontinuation

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics Parameter (PK): Cmax of INCB018424	Up to 24 weeks	Defined as maximum observed plasma concentration of INCB018424.
Pharmacokinetics Parameter: Tmax of INCB018424	Up to 24 weeks	Defined as the time to reach the maximum plasma concentration of INCB018424.
Pharmacokinetics Parameter: AUC 0-12 of INCB018424	Up to 24 weeks	Defined as the area under the plasma or serum concentration-time curve from Hour 0 to 12 hours of INCB018424.