Maximal-use ruxolitinib cream for adults and teens with hidradenitis suppurativa
A Maximal Use Trial of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa
This trial will test whether applying ruxolitinib cream over large skin areas is safe and tolerable in adults and adolescents with hidradenitis suppurativa.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 12 Years to 75 Years |
| Sex | All |
| Sponsor | Incyte Corporation Industry-sponsored |
| Drugs / interventions | ruxolitinib |
| Locations | 24 sites (Phoenix, Arizona and 23 other locations) |
| Trial ID | NCT07049575 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults and adolescents with HS of at least six months' duration who have Hurley stage I–III disease with ≥4 abscesses/inflammatory nodules across ≥3 body areas and estimated treatment BSA >20%, and who can avoid prohibited antibiotics and pregnancy during the study.
Not a fit: People with small localized HS lesions, uncontrolled serious medical conditions, other confounding skin disorders, abnormal lab values, pregnancy, or who cannot stop prohibited medications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If safe, this could enable a topical option for treating widespread HS lesions with potentially fewer systemic side effects than oral therapies.
How similar studies have performed: Topical ruxolitinib has shown benefit in conditions like atopic dermatitis and vitiligo, while systemic JAK inhibitors have shown some activity in HS, but maximal-use topical ruxolitinib for widespread HS is a novel application with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Phoenix, Arizona and 23 other locations
- Saguaro Dermatology — Phoenix, Arizona, United States (Recruiting)
- First Oc Dermatology — Fountain Valley, California, United States (Recruiting)
- Amicis Research Center Valencia — Northridge, California, United States (Recruiting)
- Children'S Hospital of Orange County — Orange, California, United States (Not_yet_recruiting)
- Clinical Trials Research Institute — Thousand Oaks, California, United States (Recruiting)
- Clarity Dermatology — Castle Rock, Colorado, United States (Recruiting)
- Advanced Pharma Cr, Llc — Miami, Florida, United States (Not_yet_recruiting)
- Advanced Pharma Cr, Llc — Miami, Florida, United States (Withdrawn)
- International Clinical Research Tennessee Llc — Sanford, Florida, United States (Recruiting)
- Lenus Research Medical Group, Llc — Sweetwater, Florida, United States (Recruiting)
- Trueblue Clinical Research — Tampa, Florida, United States (Recruiting)
- Lane Dermatology and Dermatologic Surgery — Columbus, Georgia, United States (Recruiting)
- Options Research Group, Llc — West Lafayette, Indiana, United States (Recruiting)
- Equity Medical, Llc — Bowling Green, Kentucky, United States (Recruiting)
- Delricht Research — Baton Rouge, Louisiana, United States (Recruiting)
- Revival Research Institute, Llc Troy — Troy, Michigan, United States (Recruiting)
- Red River Research Partners — Bolivar, Missouri, United States (Recruiting)
- Dr Bobby Buka, Md Greenwich Village — New York, New York, United States (Recruiting)
- Equity Medical, Llc — New York, New York, United States (Recruiting)
- Red River Research Partners — Fargo, North Dakota, United States (Recruiting)
- Centricity Research Columbus — Columbus, Ohio, United States (Recruiting)
- Unity Clinical Research — Oklahoma City, Oklahoma, United States (Recruiting)
- Paddington Testing Co Inc — Philadelphia, Pennsylvania, United States (Recruiting)
- Dermresearch, Inc. — Austin, Texas, United States (Withdrawn)
Study contacts
- Study coordinator: Incyte Corporation Call Center (US)
- Email: medinfo@incyte.com
- Phone: 1.855.463.3463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.