Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)

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

NCT06958211

Run by

Incyte Corporation

People needed

573

Starts

2025-06-12

Expected to finish

2027-07-11

Last updated by the study team

2026-07-08

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 US218 — Birmingham, Alabama, United States
• Investigative Site US239 — Montgomery, Alabama, United States
• Investigative Site US215 — Phoenix, Arizona, United States
• Investigative Site US261 — Phoenix, Arizona, United States
• Investigative Site US240 — Tucson, Arizona, United States
• Investigative Site US262 — Encino, California, United States
• Investigative Site US222 — Fountain Valley, California, United States
• Investigative Site US211 — Los Angeles, California, United States
• Investigative Site US237 — Los Angeles, California, United States
• Investigative Site US234 — Northridge, California, United States
• Investigative Site US250 — Santa Ana, California, United States
• Investigative Site US244 — Castle Rock, Colorado, United States
• Investigative Site US252 — Cromwell, Connecticut, United States
• Investigative Site US208 — Boca Raton, Florida, United States
• Investigative Site US203 — Hialeah, Florida, United States
• Investigative Site US258 — Jacksonville, Florida, United States
• Investigative Site US206 — Maitland, Florida, United States
• Investigative Site US223 — Miami, Florida, United States
• Investigative Site US241 — Miami, Florida, United States
• Investigative Site US202 — Miami, Florida, United States
• Investigative Site US214 — Tampa, Florida, United States
• Investigative Site US247 — Tampa, Florida, United States
• Investigative Site US231 — Columbus, Georgia, United States
• Investigative Site US225 — Sandy Springs, Georgia, United States
• Investigative Site US257 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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