Hidradenitis SuppurativaPhase 1NCT07049575
Study to Evaluate the Maximal Use of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa
A Phase 1 study testing Ruxolitinib Cream in people with Hidradenitis Suppurativa, run by Incyte Corporation at 21 sites in United States.
Trial summary
The purpose of this study is to evaluate the maximal use of ruxolitinib cream in adult and adolescent participants with hidradenitis suppurativa. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Ruxolitinib Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 21 sitesUnited States
- Study dates
- 3 Nov 2025to 9 Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
United States21 sites, 16 recruiting
- Recruiting
Delricht Research
Baton Rouge, Louisiana, 70809
- Recruiting
Red River Research Partners
Bolivar, Missouri, 65613
- Recruiting
Equity Medical, Llc
Bowling Green, Kentucky, 42104
- Completed
Clarity Dermatology
Castle Rock, Colorado, 80109
- Recruiting
Lane Dermatology and Dermatologic Surgery
Columbus, Georgia, 31904
- Completed
Centricity Research Columbus
Columbus, Ohio, 43213
- Recruiting
Red River Research Partners
Fargo, North Dakota, 58103
- Completed
First Oc Dermatology
Fountain Valley, California, 92708
- Recruiting
Dr Bobby Buka, Md Greenwich Village
New York, New York, 10012-1354
- Recruiting
Equity Medical, Llc
New York, New York, 10019
- Recruiting
Amicis Research Center Valencia
Northridge, California, 91324
- Recruiting
Unity Clinical Research
Oklahoma City, Oklahoma, 73118
- Recruiting
Children'S Hospital of Orange County
Orange, California, 92868
- Completed
Paddington Testing Co Inc
Philadelphia, Pennsylvania, 19103
- Recruiting
Saguaro Dermatology
Phoenix, Arizona, 85008
- Recruiting
International Clinical Research Tennessee Llc
Sanford, Florida, 32771
- Recruiting
Lenus Research Medical Group, Llc
Sweetwater, Florida, 33172
- Recruiting
Trueblue Clinical Research
Tampa, Florida, 33609
- Recruiting
Clinical Trials Research Institute
Thousand Oaks, California, 91320
- Completed
Revival Research Institute, Llc Troy
Troy, Michigan, 48084
- Recruiting
Options Research Group, Llc
West Lafayette, Indiana, 47906
About this study
Official title: A Maximal Use Trial 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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Ruxolitinib Cream
- Keywords
- Hidradenitis suppurativa, skin disease, ruxolitinb cream
- Medical subject headings
- Hidradenitis Suppurativa, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib CreamDrug
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib 1.5 % Cream | Experimental | Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol. Receives: Drug: Ruxolitinib Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Up to 24 weeks
Secondary outcomes (3)
Pharmacokinetics Parameter (PK): Cmax of INCB018424
Defined as maximum observed plasma concentration of INCB018424.
Measured: Up to 24 weeks
Pharmacokinetics Parameter: Tmax of INCB018424
Defined as the time to reach the maximum plasma concentration of INCB018424.
Measured: Up to 24 weeks
Pharmacokinetics Parameter: AUC 0-12 of INCB018424
Defined as the area under the plasma or serum concentration-time curve from Hour 0 to 12 hours of INCB018424.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start3 Nov 2025
- Primary completion9 Dec 2026 (estimated)
- Study completion9 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049575
- Sponsor's protocol ID
- INCB018424-112
- Status last verified
- Oct 2026
- First submitted
- 25 Jun 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No