A Phase 2, Double-Blind, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
Status: Completed
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants with Hidradenitis Suppurativa. This is a randomized 16-week double-blind, vehicle-controlled (DBVC) study followed by a 16 week open label extension period (OLE) with an active treatment for participants who complete the DBVC period.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosis of HS based on clinical history and physical examination for at least 3 months.
• Diagnosis of HS (Hurley I or II) with the following:
‣ A total AN count of 3 to ≤ 10, with no draining tunnels at screening and baseline visits. AND
⁃ The AN count at the screening AND baseline visits:
• AN of 3 should affect at least 1 distinct anatomical area
• AN of \> 3 to ≤ 10 should affect at least 2 distinct anatomical areas.
• Baseline Skin Pain or Itch NRS score ≥ 1.
• Agreement to NOT use topical and systemic antibiotics for treatment of HS during the study.
• Agreement to NOT use a diluted beach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the study.
• Willingness to avoid pregnancy or fathering children
Locations
United States
Arizona
Medical Dermatology Specialists Phoenix
Phoenix
California
First Oc Dermatology
Fountain Valley
Florida
Skin Care Research, Llc Scr Hollywood
Boca Raton
Forcare Clinical Research
Tampa
Georgia
Marietta Dermatology the Skin Cancer Center Marietta
Marietta
Louisiana
Delricht Research
Baton Rouge
Delricht Research
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Michigan
Revival Research Institute, Llc Troy
Troy
New York
Dr Bobby Buka, Md Greenwich Village
New York
Pennsylvania
Dermatology Associates of Plymouth Meeting
Plymouth Meeting
Tennessee
International Clinical Research Tennessee Llc
Murfreesboro
Texas
Austin Institute For Clinical Research Aicr Pflugerville
Pflugerville
Progressive Clinical Research
San Antonio
Washington
Dermatology Specialists of Spokane
Spokane
Other Locations
Canada
Dr.Wei Jing Loo Medicine Professional Corp
London
Lynderm Research Inc
Markham
Skin Centre For Dermatology
Peterborough
Xlr8 Medical Research
Windsor
Wiseman Dermatology Research Inc
Winnipeg
Time Frame
Start Date:2022-12-07
Completion Date:2024-03-14
Participants
Target number of participants:69
Treatments
Experimental: Ruxolitinib Cream
Ruxolitinib 1.5% cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.
Experimental: Vehicle Cream
Vehicle cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.