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Ruxolitinib cream for mild-to-moderate hidradenitis suppurativa

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa

Phase 3 Interventional Incyte Corporation · NCT06959225

This will test whether applying ruxolitinib cream can reduce lesions and symptoms in people with mild to moderate hidradenitis suppurativa.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment550 (estimated)
Ages12 Years and up
SexAll
SponsorIncyte Corporation Industry-sponsored
Drugs / interventionsruxolitinib
Locations101 sites (Phoenix, Arizona and 100 other locations)
Trial IDNCT06959225 on ClinicalTrials.gov

What this trial studies

This Phase 3, vehicle-controlled study compares topical ruxolitinib cream with a matching vehicle cream in participants with mild to moderate hidradenitis suppurativa (Hurley I or II). Eligible participants must have had disease for at least 6 months, at least four abscesses or nodules without draining tunnels, and involvement of two or more distinct areas. Participants agree to avoid topical and systemic antibiotics and antiseptics during the vehicle-controlled period, and there is an extension period with additional restrictions noted through Weeks 16 to 20. The study is conducted at investigational sites in the Phoenix/Scottsdale/Tempe, Arizona area.

Who should consider this trial

Good fit: Ideal candidates are people with hidradenitis suppurativa for at least 6 months with mild to moderate disease (Hurley I-II), at least four abscesses or nodules, no draining tunnels, involvement of two or more areas, and willingness to stop certain topical and systemic HS treatments during the study.

Not a fit: Patients with severe HS (Hurley III), draining tunnels, treated body surface area over 20%, active infections, relevant prior cancers or lymphoproliferative disorders, or who require ongoing systemic antibiotics are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, a topical ruxolitinib treatment could reduce inflammatory lesions and symptoms while avoiding systemic exposure from oral therapies.

How similar studies have performed: Topical ruxolitinib and other JAK inhibitors have shown positive results in other inflammatory skin diseases such as atopic dermatitis, but large-scale phase 3 data for topical JAK inhibitors specifically in hidradenitis suppurativa remain limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Phoenix, Arizona and 100 other locations

+51 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hidradenitis SuppurativaHidradenitis suppurativaskin diseaseruxolitinb cream
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.