Topical Ruxolitinib 1.5% for Hidradenitis Suppurativa Treatment

Eligibility 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.)
• 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.