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Clinical Trials in the USA / NCT06958211
Active, not recruiting Phase 3

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

NCT06958211 · tracked via the Priya Life Science USA tracker
Sponsor
Incyte Corporation
Phase
Phase 3
Started
2025-06-12
Last updated
2026-07-08

Condition(s) studied

Hidradenitis Suppurativa

Investigational drug(s) / intervention(s)

Ruxolitinib Cream →Vehicle 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 (107)

FacilityCityRegionStatus
Investigative Site US257 Birmingham Alabama
Investigative Site US218 Birmingham Alabama
Investigative Site US239 Montgomery Alabama
Investigative Site US215 Phoenix Arizona
Investigative Site US261 Phoenix Arizona
Investigative Site US240 Tucson Arizona
Investigative Site US262 Encino California
Investigative Site US222 Fountain Valley California
Investigative Site US211 Los Angeles California
Investigative Site US237 Los Angeles California
Investigative Site US234 Northridge California
Investigative Site US250 Santa Ana California
Investigative Site US244 Castle Rock Colorado
Investigative Site US252 Cromwell Connecticut
Investigative Site US208 Boca Raton Florida
Investigative Site US203 Hialeah Florida
Investigative Site US258 Jacksonville Florida
Investigative Site US206 Maitland Florida
Investigative Site US223 Miami Florida
Investigative Site US241 Miami Florida
Investigative Site US202 Miami Florida
Investigative Site US214 Tampa Florida
Investigative Site US247 Tampa Florida
Investigative Site US231 Columbus Georgia
Investigative Site US225 Sandy Springs Georgia
Investigative Site US207 Skokie Illinois
Investigative Site US205 Plainfield Indiana
Investigative Site US264 Lake Charles Louisiana
Investigative Site US266 New Orleans Louisiana
Investigative Site US254 Gambrills Maryland
Investigative Site US201 Marriottsville Maryland
Investigative Site US253 Milford Massachusetts
Investigative Site US227 Needham Massachusetts
Investigative Site US268 Worcester Massachusetts
Investigative Site US238 Ann Arbor Michigan
Investigative Site US230 Auburn Hills Michigan
Investigative Site US251 St Louis Missouri
Investigative Site US271 Wildwood Missouri
Investigative Site US212 Missoula Montana
Investigative Site US216 Las Vegas Nevada

+ 67 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 NCT06958211 on ClinicalTrials.gov ↗ ← All trials in the USA