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NCT Number: NCT07049575

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

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

Recruiting

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Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Saguaro Dermatology, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ruxolitinib Cream

Drug

Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

Primary outcomes

  1. 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.

  2. 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

  1. Pharmacokinetics Parameter (PK): Cmax of INCB018424

    Time frame: Up to 24 weeks

    Defined as maximum observed plasma concentration of INCB018424.

  2. Pharmacokinetics Parameter: Tmax of INCB018424

    Time frame: Up to 24 weeks

    Defined as the time to reach the maximum plasma concentration of INCB018424.

  3. Pharmacokinetics Parameter: AUC 0-12 of INCB018424

    Time frame: Up to 24 weeks

    Defined as the area under the plasma or serum concentration-time curve from Hour 0 to 12 hours of INCB018424.

Study contacts

Contact information is provided by the study sponsor or research team.

Incyte Corporation Call Center (US)

CONTACT

[email protected]

1.855.463.3463

Incyte Corporation Call Center (ex-US)

CONTACT

[email protected]

+800 00027423

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

A Maximal Use Trial of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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