Status:
RECRUITING
Topical Ruxolitinib 1.5% for Hidradenitis Suppurativa Treatment
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
Incyte Corporation
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief 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 effica...
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% reduct...
Eligibility Criteria
Inclusion
- 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.)
Exclusion
- 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.
Key Trial Info
Start Date :
October 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04414514
Start Date
October 13 2022
End Date
January 1 2028
Last Update
November 29 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033