Hidradenitis SuppurativaPhase 2NCT04414514
Topical Ruxolitinib 1.5% for Hidradenitis Suppurativa Treatment
A Phase 2 study testing Ruxolitinib 1.5% Cream in people with Hidradenitis Suppurativa, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
Investigators hypothesize that ruxolitinib 1.5% cream is an effective therapy for HS participants through inhibition of inflammatory activity. Investigators aim to: Demonstrate the clinical efficacy of ruxolitinib 1.5% cream in decreasing the clinical disease activity after 16 weeks of treatment. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Ruxolitinib 1.5% Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2022to 23 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subjects age 12 years or older
- Hidradenitis suppurativa, and should be Hurley Stage I or II, defined as papules, nodules, and/or abscess formation, single or multiple, with or without sinus tracts;
- Subjects must have a diagnosis of HS for at least 3 months (90 days) prior to Baseline;
- Active HS lesions must be present in at least one distinct anatomic area;
- Subject must have at least 3 total inflammatory lesions at the Baseline visit;
- Subjects who had surgery in the treatment area, should be at least 3 months status post the procedure (this applies to deroofing/marsupialization or excision, not incision \& drainage)
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- Subject has a negative TB screening assessment (including a PPD test and/or Quantiferon-TB Gold test equivalent) OR for patients with treated latent TB or negative chest x-ray (CXR posterior-anterior [PA] and lateral view within prior 90 days) at Screening with documentation of treated latent tuberculosis (90 days of treatment).
- Medications can be continued if they have been at a stable dose for the requisite duration and the dose is not increased during the study period:
- Biologic medication (such as TNF, IL-12/23 or IL-17 inhibitors): Up to 30% of enrolled participants will be allowed to remain on a concurrent biologic at stable dosage if treated with a stable dose and frequency for 6 months or longer;
- Oral antibiotic must be a stable dose and frequency for 28 days or longer;
- Hormone-based therapy (birth control pills or spironolactone) must be a stable dose and frequency for 4 months or longer;
- Oral retinoids must be on a stable dose and frequency for 90 days or longer;
- Other topical therapy must be discontinued 14 days prior to the Baseline visit.
- Child bearing potential: In addition, you must be willing to use a method of contraception during the study period and for 4 weeks after the last dose of study drug. (Note: Periodic abstinence calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable as abstinence.)
Who cannot join
- Infection(s) unrelated to HS requiring treatment with:
- intravenous (IV) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to Baseline or;
- oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to Baseline, except as required as part of an anti-TB regimen;
- Subject previously treated with a biologic medication but stopped due to lack of effect/sufficient effect as deemed by the investigator.
- Any other active skin disease or condition (e.g., bacterial, fungal or viral infection) that may interfere with assessment of HS;
- Pregnant (or considering becoming pregnant) or lactating females Note: Non child bearing potential is defined as surgically sterile with a hysterectomy and/or bilateral oophorectomy OR postmenopausal (defined as amenorrhea at least 12 months before screening, confirmed by FSH levels at screening).
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- Clinically significant abnormal screening laboratory results as evaluated by the Investigator.
- Subject does not have reliable internet access for weekly electronic surveys;
- Subject is considered by the Study Investigator, for any reason, to be an unsuitable candidate for the study.
- Excluded prohibited concomitant medication and procedures include: JAK inhibitors (systemic or topical (eg, ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, and pacritinib) within 4 weeks of Screening ; surgical, laser, or IPL intervention in area with HS lesion within 3 months of Screening, except for rescue lesional treatment; systemic corticosteroid within 4 weeks; use of topical creams, ointments, gels, and liquids except the study therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Exploratory Trial of Ruxolitinib 1.5% Cream for the Treatment of Early Stage Hidradenitis Suppurativa
Investigators hypothesize that ruxolitinib 1.5% cream is an effective therapy for HS participants through inhibition of inflammatory activity.
Investigators aim to:
- Demonstrate the clinical efficacy of ruxolitinib 1.5% cream in decreasing the clinical disease activity after 16 weeks of treatment.
- Investigate the impact of ruxolitinib 1.5% cream on skin inflammation through translational analyses of skin biopsy samples.
Read the detailed description
The primary efficacy measure is the proportion of participants that achieve HiSCR at Week 16 with topical ruxolitinib 1.5% cream as compared to Week 0. The HiSCR is defined as an at least a 50% reduction in the total abscess and inflammatory nodule count (AN count) for all study body sites with no increase in abscess count and no increase in draining fistula count relative to Baseline. The primary efficacy analysis will be carried out on all participants who complete 16 weeks of treatment.
The research study consists of an 8 week screening with 16 weeks open-label portion.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Ruxolitinib 1.5% Cream
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib 1.5% CreamDrug
Topical Ruxolitinib 1.5% Cream
| Study group | Role | What they receive |
|---|---|---|
| Open-label | Experimental | Topical Ruxolitinib 1.5% Cream, twice daily for 16 weeks Receives: Drug: Ruxolitinib 1.5% Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR)
The HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (AN count) for all study body sites with no increase in abscess count and no increase in draining fistula count relative to Baseline.
Measured: 16 weeks after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start13 Oct 2022
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Why it stopped: The PI left the Institution and sponsor decided to close the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Principal investigator, Andrea Zaenglein, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414514
- Sponsor's protocol ID
- 16042
- Status last verified
- Aug 2025
- First submitted
- 2 Jun 2020
- Last updated
- 28 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Trial of Ruxolitinib 1.5% Cream for the Treatment of Early Stage Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT04414514
- Acronym / sponsor ID
- 16042
- Conditions
- Hidradenitis Suppurativa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI left the Institution and sponsor decided to close the trial.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Posted 28 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators hypothesize that ruxolitinib 1.5% cream is an effective therapy for HS participants through inhibition of inflammatory activity.
Investigators aim to:
- Demonstrate the clinical efficacy of ruxolitinib 1.5% cream in decreasing the clinical disease activity after 16 weeks of treatment.
- Investigate the impact of ruxolitinib 1.5% cream on skin inflammation through translational analyses of skin biopsy samples.
Detailed description
The primary efficacy measure is the proportion of participants that achieve HiSCR at Week 16 with topical ruxolitinib 1.5% cream as compared to Week 0. The HiSCR is defined as an at least a 50% reduction in the total abscess and inflammatory nodule count (AN count) for all study body sites with no increase in abscess count and no increase in draining fistula count relative to Baseline. The primary efficacy analysis will be carried out on all participants who complete 16 weeks of treatment.
The research study consists of an 8 week screening with 16 weeks open-label portion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| Open-label | Experimental | Drug: Ruxolitinib 1.5% CreamTopical Ruxolitinib 1.5% Cream, twice daily for 16 weeks |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female subjects age 12 years or older
- Hidradenitis suppurativa, and should be Hurley Stage I or II, defined as papules, nodules, and/or abscess formation, single or multiple, with or without sinus tracts;
- Subjects must have a diagnosis of HS for at least 3 months (90 days) prior to Baseline;
- Active HS lesions must be present in at least one distinct anatomic area;
- Subject must have at least 3 total inflammatory lesions at the Baseline visit;
Key exclusion criteria (10 listed)
- Infection(s) unrelated to HS requiring treatment with:
- Subject previously treated with a biologic medication but stopped due to lack of effect/sufficient effect as deemed by the investigator.
- Any other active skin disease or condition (e.g., bacterial, fungal or viral infection) that may interfere with assessment of HS;
- Pregnant (or considering becoming pregnant) or lactating females Note: Non child bearing potential is defined as surgically sterile with a hysterectomy and/or bilateral oophorectomy OR postmenopausal (defined as amenorrhea at least 12 months before screening, confirmed by FSH levels at screening).
- Clinically significant abnormal screening laboratory results as evaluated by the Investigator.
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 1.5% CreamTopical Ruxolitinib 1.5% Cream | Drug | Open-label |
Primary outcome
Number of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR)
Time frame: 16 weeks after treatment.
The HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (AN count) for all study body sites with no increase in abscess count and no increase in draining fistula count relative to Baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ruxolitinib 1.5% Cream in people with Hidradenitis Suppurativa, run by Milton S. Hershey Medical Center at 1 site 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 14 inclusion and 10 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: stopped early, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR) (time frame: 16 weeks after treatment.). 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 28 Apr 2026.