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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Maximal Use Trial of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT07049575
- Acronym / sponsor ID
- INCB018424-112
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis suppurativa, skin disease, ruxolitinb cream
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 9 Dec 2026 (estimated)
- Study completion
- 9 Dec 2026 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the maximal use of ruxolitinib cream in adult and adolescent participants with hidradenitis suppurativa.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib 1.5 % Cream | Experimental | Drug: Ruxolitinib CreamParticipants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib CreamRuxolitinib cream applied topically to the affected area as a thin film twice daily. | Drug | Ruxolitinib 1.5 % Cream |
Primary outcome
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.
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
3 secondary outcomes
Pharmacokinetics Parameter (PK): Cmax of INCB018424
Time frame: Up to 24 weeks
Pharmacokinetics Parameter: Tmax of INCB018424
Time frame: Up to 24 weeks
Pharmacokinetics Parameter: AUC 0-12 of INCB018424
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Study to Evaluate the Maximal Use of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis SuppurativaLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Hidradenitis Suppurativa
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Incyte Medical Monitor study director
Incyte Corporation
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ruxolitinib Cream in people with Hidradenitis Suppurativa, run by Incyte Corporation at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Incyte Corporation Call Center (US) (1.855.463.3463, medinfo@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.