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

Incyte

Status and phase: Enrolling; Phase 1

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Ruxolitinib Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT07049575

INCB018424-112

Details and patient eligibility

About

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

Enrollment: 24 estimated patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Ruxolitinib 1.5 % Cream

Experimental group

Description:

Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.

Treatment:

Drug: Ruxolitinib Cream