Status:
RECRUITING
Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)
Lead Sponsor:
Incyte Corporation
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 11 2027
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06959225
Start Date
June 23 2025
End Date
July 11 2027
Last Update
December 18 2025
Active Locations (106)
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1
Investigative Site US020
Phoenix, Arizona, United States, 85008
2
Investigative Site US033
Scottsdale, Arizona, United States, 85259
3
Investigative Site US054
Tempe, Arizona, United States, 85282
4
Investigative Site US002
Fayetteville, Arkansas, United States, 72703