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Clinical Trials in the USA / NCT06959225
Active, not recruiting Phase 3

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

NCT06959225 · tracked via the Priya Life Science USA tracker
Sponsor
Incyte Corporation
Phase
Phase 3
Started
2025-06-23
Last updated
2026-07-28

Condition(s) studied

Hidradenitis Suppurativa

Investigational drug(s) / intervention(s)

Ruxolitinib CreamVehicle Cream

Ruxolitinib Cream: Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

Vehicle Cream: Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Study summary

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

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (101)

FacilityCityRegionStatus
Investigative Site US020 Phoenix Arizona
Investigative Site US033 Scottsdale Arizona
Investigative Site US054 Tempe Arizona
Investigative Site US002 Fayetteville Arkansas
Investigative Site US055 Brea California
Investigative Site US004 Laguna Niguel California
Investigative Site US007 Los Angeles California
Investigative Site US013 San Diego California
Investigative Site US060 San Diego California
Investigative Site US038 San Diego California
Investigative Site US059 Aurora Colorado
Investigative Site US045 Boynton Beach Florida
Investigative Site US028 Fort Myers Florida
Investigative Site US016 Miami Florida
Investigative Site US027 Sanford Florida
Investigative Site US057 Sweetwater Florida
Investigative Site US029 Tampa Florida
Investigative Site US061 Atlanta Georgia
Investigative Site US053 Atlanta Georgia
Investigative Site US019 Marietta Georgia
Investigative Site US026 Chicago Illinois
Investigative Site US049 Clarksville Indiana
Investigative Site US052 West Lafayette Indiana
Investigative Site US001 Bowling Green Kentucky
Investigative Site US022 Louisville Kentucky
Investigative Site US050 Baton Rouge Louisiana
Investigative Site US046 Glenn Dale Maryland
Investigative Site US003 Boston Massachusetts
Investigative Site US030 Boston Massachusetts
Investigative Site US010 Quincy Massachusetts
Investigative Site US051 Novi Michigan
Investigative Site US006 Minneapolis Minnesota
Investigative Site US021 New Brighton Minnesota
Investigative Site US036 Saint Joseph Missouri
Investigative Site US034 New City New York
Investigative Site US018 New York New York
Investigative Site US017 New York New York
Investigative Site US023 Rochester New York
Investigative Site US014 Chapel Hill North Carolina
Investigative Site US025 Fargo North Dakota

+ 61 more sites — see the full list on the official registry below.

More Incyte Corporation trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06959225 on ClinicalTrials.gov ↗ ← All trials in the USA