Topical Ruxolitinib 1.5% for Hidradenitis Suppurativa Treatment

Last updated: November 26, 2024
Sponsor: Milton S. Hershey Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

Scalp Disorders

Hidradenitis Suppurativa

Rosacea

Treatment

Ruxolitinib 1.5% Cream

Clinical Study ID

NCT04414514
001
  • Ages > 12
  • All Genders

Study 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.

  • Investigate the impact of ruxolitinib 1.5% cream on skin inflammation through translational analyses of skin biopsy samples.

Eligibility Criteria

Inclusion

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 toBaseline;

  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 statuspost the procedure (this applies to deroofing/marsupialization or excision, notincision & drainage)

  7. Subject has a negative TB screening assessment (including a PPD test and/orQuantiferon-TB Gold test equivalent) OR for patients with treated latent TB ornegative chest x-ray (CXR posterior-anterior [PA] and lateral view within prior 90days) at Screening with documentation of treated latent tuberculosis (90 days oftreatment).

  8. Medications can be continued if they have been at a stable dose for the requisiteduration 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% ofenrolled participants will be allowed to remain on a concurrent biologic atstable dosage if treated with a stable dose and frequency for 6 months orlonger;

  • 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 stabledose 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 ofcontraception during the study period and for 4 weeks after the last dose ofstudy drug. (Note: Periodic abstinence calendar, ovulation, symptothermal,post-ovulation methods] and withdrawal are not acceptable as abstinence.)

Exclusion

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 daysprior to Baseline, except as required as part of an anti-TB regimen;

  1. Subject previously treated with a biologic medication but stopped due to lack ofeffect/sufficient effect as deemed by the investigator.

  2. Any other active skin disease or condition (e.g., bacterial, fungal or viralinfection) that may interfere with assessment of HS;

  3. Pregnant (or considering becoming pregnant) or lactating females Note: Non childbearing potential is defined as surgically sterile with a hysterectomy and/orbilateral oophorectomy OR postmenopausal (defined as amenorrhea at least 12 monthsbefore screening, confirmed by FSH levels at screening).

  4. Clinically significant abnormal screening laboratory results as evaluated by theInvestigator.

  5. Subject does not have reliable internet access for weekly electronic surveys;

  6. Subject is considered by the Study Investigator, for any reason, to be an unsuitablecandidate for the study.

  7. 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 IPLintervention in area with HS lesion within 3 months of Screening, except for rescuelesional treatment; systemic corticosteroid within 4 weeks; use of topical creams,ointments, gels, and liquids except the study therapy.

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Ruxolitinib 1.5% Cream
Phase: 2
Study Start date:
October 13, 2022
Estimated Completion Date:
January 31, 2028

Study 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.

Connect with a study center

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.