Maximal-use ruxolitinib cream for adults and teens with hidradenitis suppurativa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional study applies ruxolitinib cream using a maximal-use regimen to measure safety, tolerability, and systemic exposure in participants with hidradenitis suppurativa. Eligible participants must have had HS for at least six months, at least four abscesses or inflammatory nodules affecting three or more anatomical areas, and estimated treatment body surface area greater than 20%. Participants agree to avoid topical or systemic antibiotics for HS during the treatment period and follow contraception requirements. The study is conducted at dermatology research sites in Arizona and California with in-person visits for treatment and monitoring.

Why it matters

Who can join: the full rules

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.

Where it's running

• Saguaro Dermatology
  Phoenix, Arizona, United States Recruiting
• Amicis Research Center Valencia
  Northridge, California, United States Recruiting
• Children'S Hospital of Orange County
  Orange, California, United States Recruiting
• Clinical Trials Research Institute
  Thousand Oaks, California, United States Recruiting
• International Clinical Research Tennessee Llc
  Sanford, Florida, United States Recruiting
• Lenus Research Medical Group, Llc
  Sweetwater, Florida, United States Recruiting

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)
• Email: medinfo@incyte.com
• Phone: 1.855.463.3463

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Belumosudil vs. Ruxolitinib for hepatic cGVHD after HSCT

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.