Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorIncyte Corporation

About this trial

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

Eligibility criteria

Qualifiers

Diagnosis of HS for at least 6 months prior to screening visit.

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Ruxolitinib Cream
  • Vehicle Cream

Treatment groups

550 Participants
are divided into 2 treatment groups

Sponsors and collaborators