RECRUITING

Topical Ruxolitinib 1.5% for Hidradenitis Suppurativa Treatment

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-13

Study Completion:2028-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04414514

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Andrea Zaenglein, MD

CONTACT

717-531-1513

azaenglein@pennstatehealth.psu.edu

Study Locations (Sites)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033

United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-13

Study Completion Date2028-01

Study Record Updates

Study Start Date2022-10-13

Study Completion Date2028-01

Terms related to this study

Additional Relevant MeSH Terms

Hidradenitis Suppurativa