Ruxolitinib cream for people with mild to moderate hidradenitis suppurativa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Investigative Site US257
  Birmingham, Alabama, United States Recruiting
• Investigative Site US218
  Birmingham, Alabama, United States Recruiting
• Investigative Site US239
  Montgomery, Alabama, United States Recruiting
• Investigative Site US215
  Phoenix, Arizona, United States Recruiting
• Investigative Site US261
  Phoenix, Arizona, United States Recruiting
• Investigative Site US240
  Tucson, Arizona, United States Recruiting

+57 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)
• Email: medinfo@incyte.com
• Phone: 1.855.463.3463

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Maximal-use ruxolitinib cream for adults and teens with hidradenitis suppurativa

  This trial will test whether applying ruxolitinib cream over large skin areas is safe and tolerable in adults and adolescents with hidradenitis suppurativa.

  Recruiting at 16 sites Phase 1 Incyte Corporation · Phoenix, Arizona and 20 other locations · NCT07049575

• Graft-versus-host disease after stem cell transplant: testing LBP-MARCO with ruxolitinib

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• BTK inhibitor remibrutinib in hidradenitis suppurativa shows how it works in adults

  This phase 1 trial tests whether remibrutinib can safely affect HS in adults with moderate to severe disease.

  Recruiting at 2 sites Phase 1 Novartis · San Diego, California and 1 other locations · NCT07855276

• DMR-001 in CALR-mutant myeloproliferative neoplasms

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  Recruiting at 3 sites Phase 1 Damora Therapeutics · Birmingham, Alabama and 35 other locations · NCT07849231

• Olatorepatide vs placebo for adults with moderate-to-severe hidradenitis suppurativa who are overweight

  This study tests whether olatorepatide can help people with hidradenitis suppurativa who are overweight or obese.

  Recruiting Phase 2 Regeneron Pharmaceuticals · The Bronx, New York · NCT07830329

• Testing WJ01024 Alone and with Ruxolitinib for Myelofibrosis with Splenomegaly

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.