Hidradenitis Suppruativa Study (12 Years+)

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa

Study Description

 

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.

Condition or Disease

Hidradenitis Suppruativa

Study Design

Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 450
Primary Outcome Measures
1. Proportion of participants who achieve Hidradenitis Suppurativa (HS) Clinical Response 75 (HiSCR75) from baseline
Actual Study Start Date: June 2025
Estimated Primary Completion Date: October 2026

Eligibility Criteria

Ages Eligible for Study: 12 & Older
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Study Population

Hidradenitis Supurativa

 

Inclusion Criteria

  • Diagnosis of HS for at least 6 months prior to screening visit
  • Mild to moderate HS (Hurley I or II) with the following at both screening and baseline visits: total AN count of at least 4, with no draining tunnels AND affecting at least 2 distinct anatomical areas
  • Agreement to NOT use topical and systemic antibiotics for treatment of HS during the vehicle-controlled period
  • Agreement to NOT use topical antiseptics, including washes and leave-on products on the areas affected by HS lesions during the vehicle-controlled period and Weeks 16 to 20 of the extension period

Exclusion Criteria

  • Body surface areas to be treated exceed 20% BSA at screening or baseline
  • Presence of draining tunnels at screening or baseline
  • Medical history including current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
  • Laboratory values outside of the protocol-defined criteria
  • Pregnant or lactating participants, or those considering pregnancy during the period of their study participation
ADDITIONAL DETAILS