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

Not Applicable

Recruiting

• Conditions: Hidradenitis Suppurativa
• Interventions: Drug: Ruxolitinib Cream

• 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

• Study First Submitted: 2025-06-25
• Study First Submitted QC: 2025-06-25
• Study First Posted: 2025-07-03
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-10
• Last Update Posted: 2025-10-14
• Study Start: 2025-10-15
• Primary Completion: 2026-12-09
• Study Completion: 2026-12-09

Recruitment & Eligibility

• Status: 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

Arm && Interventions

Group	Intervention	Description
Ruxolitinib 1.5 % Cream	Ruxolitinib Cream	Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.

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.

Trial Locations

Locations (18)

Amicis Research Center Valencia; 🇺🇸 Northridge, California, United States

Saguaro Dermatology; 🇺🇸 Phoenix, Arizona, United States

First Oc Dermatology; 🇺🇸 Fountain Valley, California, United States

Clinical Trials Research Institute; 🇺🇸 Thousand Oaks, California, United States

Clarity Dermatology; 🇺🇸 Castle Rock, Colorado, United States

International Clinical Research Tennessee Llc; 🇺🇸 Sanford, Florida, United States

Lenus Research Medical Group, Llc; 🇺🇸 Sweetwater, Florida, United States

Trueblue Clinical Research; 🇺🇸 Tampa, Florida, United States

Lane Dermatology and Dermatologic Surgery; 🇺🇸 Columbus, Georgia, United States

Equity Medical, Llc; 🇺🇸 New York, New York, United States

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