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

Running, not enrolling · Phase 3

Conditions studied: Hidradenitis Suppurativa

In brief

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

Key facts

Study ID

NCT06959225

Run by

Incyte Corporation

People needed

580

Starts

2025-06-23

Expected to finish

2027-07-11

Last updated by the study team

2026-07-28

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigative Site US033 — Scottsdale, Arizona, United States
• Investigative Site US054 — Tempe, Arizona, United States
• Investigative Site US002 — Fayetteville, Arkansas, United States
• Investigative Site US055 — Brea, California, United States
• Investigative Site US004 — Laguna Niguel, California, United States
• Investigative Site US007 — Los Angeles, California, United States
• Investigative Site US013 — San Diego, California, United States
• Investigative Site US060 — San Diego, California, United States
• Investigative Site US038 — San Diego, California, United States
• Investigative Site US059 — Aurora, Colorado, United States
• Investigative Site US045 — Boynton Beach, Florida, United States
• Investigative Site US028 — Fort Myers, Florida, United States
• Investigative Site US016 — Miami, Florida, United States
• Investigative Site US027 — Sanford, Florida, United States
• Investigative Site US057 — Sweetwater, Florida, United States
• Investigative Site US029 — Tampa, Florida, United States
• Investigative Site US061 — Atlanta, Georgia, United States
• Investigative Site US053 — Atlanta, Georgia, United States
• Investigative Site US019 — Marietta, Georgia, United States
• Investigative Site US026 — Chicago, Illinois, United States
• Investigative Site US049 — Clarksville, Indiana, United States
• Investigative Site US052 — West Lafayette, Indiana, United States
• Investigative Site US001 — Bowling Green, Kentucky, United States
• Investigative Site US022 — Louisville, Kentucky, United States
• Investigative Site US020 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.