Topical Ruxolitinib 1.5% for Hidradenitis Suppurativa Treatment

Stopped early · Phase 2

Conditions studied: Hidradenitis Suppurativa

In brief

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.

Key facts

Study ID

NCT04414514

Run by

Milton S. Hershey Medical Center

People needed

6

Starts

2022-10-13

Expected to finish

2024-02-23

Last updated by the study team

2026-04-28

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• 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.)

You may not qualify if…

• 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).
• 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.

Where it is running

• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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