Study to Evaluate the Maximal Use of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa
A Maximal Use Trial of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa
1 other identifier
interventional
24
1 country
23
Brief Summary
The purpose of this study is to evaluate the maximal use of ruxolitinib cream in adult and adolescent participants with hidradenitis suppurativa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2025
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2025
CompletedFirst Posted
Study publicly available on registry
July 3, 2025
CompletedStudy Start
First participant enrolled
November 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 9, 2026
March 23, 2026
March 1, 2026
1.1 years
June 25, 2025
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after the first application of study drug.
Up to 24 weeks
Number of participants with TEAEs leading to treatment interruption, discontinuation
Number of participants with TEAEs leading to dose interruption or discontinuation
Up to 24 weeks
Secondary Outcomes (3)
Pharmacokinetics Parameter (PK): Cmax of INCB018424
Up to 24 weeks
Pharmacokinetics Parameter: Tmax of INCB018424
Up to 24 weeks
Pharmacokinetics Parameter: AUC 0-12 of INCB018424
Up to 24 weeks
Study Arms (1)
Ruxolitinib 1.5 % Cream
EXPERIMENTALParticipants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
Interventions
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Saguaro Dermatology
Phoenix, Arizona, 85008, United States
First Oc Dermatology
Fountain Valley, California, 92708, United States
Amicis Research Center Valencia
Northridge, California, 91324, United States
Children'S Hospital of Orange County
Orange, California, 92868, United States
Clinical Trials Research Institute
Thousand Oaks, California, 91320, United States
Clarity Dermatology
Castle Rock, Colorado, 80109, United States
Advanced Pharma Cr, Llc
Miami, Florida, 33147, United States
International Clinical Research Tennessee Llc
Sanford, Florida, 32771, United States
Lenus Research Medical Group, Llc
Sweetwater, Florida, 33172, United States
Trueblue Clinical Research
Tampa, Florida, 33609, United States
Lane Dermatology and Dermatologic Surgery
Columbus, Georgia, 31904, United States
Options Research Group, Llc
West Lafayette, Indiana, 47906, United States
Equity Medical, Llc
Bowling Green, Kentucky, 42104, United States
Delricht Research
Baton Rouge, Louisiana, 70809, United States
Revival Research Institute, Llc Troy
Troy, Michigan, 48084, United States
Red River Research Partners
Bolivar, Missouri, 65613, United States
Dr Bobby Buka, Md Greenwich Village
New York, New York, 10012-1354, United States
Equity Medical, Llc
New York, New York, 10019, United States
Red River Research Partners
Fargo, North Dakota, 58103, United States
Centricity Research Columbus
Columbus, Ohio, 43213, United States
Unity Clinical Research
Oklahoma City, Oklahoma, 73118, United States
Paddington Testing Co Inc
Philadelphia, Pennsylvania, 19103, United States
Dermresearch, Inc.
Austin, Texas, 78759, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Incyte Medical Monitor
Incyte Corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2025
First Posted
July 3, 2025
Study Start
November 3, 2025
Primary Completion (Estimated)
December 9, 2026
Study Completion (Estimated)
December 9, 2026
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share