Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)

Launched by INCYTE CORPORATION · Apr 28, 2025

Keywords

ClinConnect Summary

This clinical trial, called TRuE-HS1, is looking at the effectiveness and safety of a cream called ruxolitinib for treating people with hidradenitis suppurativa (HS), a painful skin condition. The study is specifically for adults who have had HS for at least six months and have mild to moderate symptoms, meaning they have a certain number of skin lesions but no draining tunnels. Participants will need to avoid using antibiotics or antiseptic products on the affected areas during the study.

To be eligible, participants must be at least 18 years old and have HS affecting at least two different areas of their body. However, those with more severe symptoms or certain medical histories will not be able to join. The trial is not yet recruiting, but once it starts, participants can expect to apply the cream and attend regular check-ups to monitor their progress. This study aims to provide important information about a new treatment option for those living with HS.

Gender

ALL

Eligibility criteria

• 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:
• • A 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.
• • Further inclusion criteria apply.
• 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.
• • Further exclusion criteria apply.