RECRUITING

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

Description

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

Conditions

Hidradenitis Suppurativa
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Related Conditions:

Hidradenitis Suppurativa

Study Overview

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Study Details

Study overview

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

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

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

Condition
Hidradenitis Suppurativa
Intervention / Treatment

-

Contacts and Locations

Phoenix

Investigative Site US020, Phoenix, Arizona, United States, 85008

Scottsdale

Investigative Site US033, Scottsdale, Arizona, United States, 85259

Tempe

Investigative Site US054, Tempe, Arizona, United States, 85282

Fayetteville

Investigative Site US002, Fayetteville, Arkansas, United States, 72703

Chino

Investigative Site US055, Chino, California, United States, 91710

Laguna Niguel

Investigative Site US004, Laguna Niguel, California, United States, 92677

Los Angeles

Investigative Site US007, Los Angeles, California, United States, 90033

San Diego

Investigative Site US013, San Diego, California, United States, 92103

San Diego

Investigative Site US060, San Diego, California, United States, 92120

San Diego

Investigative Site US038, San Diego, California, United States, 92121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Incyte Corporation,

Incyte Study Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

2027-07-11