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

Purpose

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

Condition

Hidradenitis Suppurativa

Eligibility

Eligible Ages: Over 12 Years
Eligible Genders: All
Accepts 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.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Ruxolitinib 1.5 % Cream	Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.	Drug: Ruxolitinib Cream Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Placebo Comparator Vehicle Cream	Participants received vehicle cream, applied topically to the affected area as defined by the protocol.	Drug: Vehicle Cream Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Recruiting Locations

Investigative Site US208
Boca Raton, Florida 33486

Investigative Site US202
Miami, Florida 33173

More Details

NCT ID: NCT06958211
Status: Recruiting
Sponsor: Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.