Topical treatment for Hidradenitis Suppurativa using Ruxolitinib cream

Exploratory Trial of Ruxolitinib 1.5% Cream for the Treatment of Early Stage Hidradenitis Suppurativa

This study is testing if a cream called Ruxolitinib can help people with Hidradenitis Suppurativa by reducing their skin inflammation and lesions.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: Milton S. Hershey Medical Center (Academic / other)
• Drugs / interventions: ruxolitinib, tofacitinib, baricitinib, filgotinib, lestaurtinib, pacritinib
• Locations: 1 site (Hershey, Pennsylvania)
• Trial ID: NCT04414514 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy of a 1.5% topical Ruxolitinib cream for treating Hidradenitis Suppurativa (HS) by targeting inflammatory activity. Participants will undergo an 8-week screening followed by a 16-week open-label treatment phase, during which the primary measure of success will be the reduction in inflammatory lesions. Skin biopsy samples will also be analyzed to assess the impact of the treatment on skin inflammation. The goal is to demonstrate a significant decrease in clinical disease activity after the treatment period.

Who should consider this trial

Good fit: Ideal candidates include males and females aged 12 years or older with a diagnosis of Hurley Stage I or II Hidradenitis Suppurativa.

Not a fit: Patients with advanced stages of Hidradenitis Suppurativa or those who have had recent surgery in the treatment area may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from Hidradenitis Suppurativa.

How similar studies have performed: While this approach is novel for Hidradenitis Suppurativa, similar topical treatments targeting inflammation have shown promise in other dermatological conditions.

Eligibility criteria

Inclusion Criteria:

1. Male or female subjects age 12 years or older
2. 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;
3. Subjects must have a diagnosis of HS for at least 3 months (90 days) prior to Baseline;
4. Active HS lesions must be present in at least one distinct anatomic area;
5. Subject must have at least 3 total inflammatory lesions at the Baseline visit;
6. 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)
7. 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).
8. 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.)

Exclusion Criteria:

1. 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;
2. Subject previously treated with a biologic medication but stopped due to lack of effect/sufficient effect as deemed by the investigator.
3. Any other active skin disease or condition (e.g., bacterial, fungal or viral infection) that may interfere with assessment of HS;
4. 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).
5. Clinically significant abnormal screening laboratory results as evaluated by the Investigator.
6. Subject does not have reliable internet access for weekly electronic surveys;
7. Subject is considered by the Study Investigator, for any reason, to be an unsuitable candidate for the study.
8. 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 this trial is running

Hershey, Pennsylvania

• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Andrea Zaenglein, MD

Conditions Hidradenitis Suppurativa