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Ruxolitinib cream for people with 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 · NCT06958211

This trial tests whether applying ruxolitinib cream can reduce bumps, inflammation, 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
Locations107 sites (Birmingham, Alabama and 106 other locations)
Trial IDNCT06958211 on ClinicalTrials.gov

What this trial studies

TRuE-HS2 is a phase 3, randomized, vehicle-controlled trial comparing topical ruxolitinib cream to a vehicle cream in participants with mild to moderate hidradenitis suppurativa. Eligible participants must have had HS for at least six months, Hurley stage I or II with at least four inflammatory nodules/abscesses, no draining tunnels, lesions in at least two distinct anatomical areas, and ≤20% body surface area affected. Participants agree to avoid topical and systemic antibiotics and topical antiseptics during the vehicle-controlled period, and the protocol includes an extension phase with restrictions through Weeks 16 to 20. The trial is sponsored by Incyte and is recruiting at investigative sites in Birmingham and Montgomery, Alabama.

Who should consider this trial

Good fit: Ideal candidates are adults with at least six months of HS who have mild to moderate disease (Hurley I–II) with ≥4 inflammatory nodules/abscesses, no draining tunnels, lesions in two or more areas, and who can attend one of the Alabama sites and avoid prohibited topical or systemic treatments.

Not a fit: Patients with severe (Hurley III) disease, active draining tunnels, more than 20% BSA affected, certain active infections, cancer or lymphoproliferative disorders, disqualifying lab abnormalities, or an inability to stop antibiotics/antiseptics are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the cream could provide a topical option to reduce lesions and inflammation and improve symptoms for people with mild to moderate HS.

How similar studies have performed: Ruxolitinib cream has shown efficacy in other inflammatory skin conditions and this program follows parallel phase 3 efforts (including TRuE-HS1), so the approach has some supporting evidence though HS-specific results are still emerging.

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

Birmingham, Alabama and 106 other locations

+57 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 2026-06-10 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.