RECRUITING

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

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Conditions

Hidradenitis Suppurativaskin diseaseruxolitinb cream

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-06-11
Study Completion:2027-07-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06959225

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.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of HS for at least 6 months prior to screening visit.
  2. * Mild to moderate HS (Hurley I or II) with the following at both screening and baseline visits:
  3. * A total AN count of at least 4, with no draining tunnels AND
  4. * Affecting at least 2 distinct anatomical areas
  5. * Agreement to NOT use topical and systemic antibiotics for treatment of HS during the vehicle-controlled period.
  6. * 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.
  7. * Further inclusion criteria apply.
  1. * Body surface areas to be treated exceed 20% BSA at screening or baseline
  2. * Presence of draining tunnels at screening or baseline.
  3. * Medical history including current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
  4. * Laboratory values outside of the protocol-defined criteria.
  5. * Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
  6. * Further exclusion criteria apply.

Contacts and Locations

Study Contact

Incyte Corporation Call Center (US)
CONTACT
1.855.463.3463
medinfo@incyte.com
Incyte Corporation Call Center (ex-US)
CONTACT
+800 00027423
eumedinfo@incyte.com

Principal Investigator

Incyte Study Monitor
STUDY_DIRECTOR
Incyte Corporation

Study Locations (Sites)

Investigative Site US020
Phoenix, Arizona, 85008
United States
Investigative Site US033
Scottsdale, Arizona, 85259
United States
Investigative Site US054
Tempe, Arizona, 85282
United States
Investigative Site US002
Fayetteville, Arkansas, 72703
United States
Investigative Site US055
Chino, California, 91710
United States
Investigative Site US004
Laguna Niguel, California, 92677
United States
Investigative Site US007
Los Angeles, California, 90033
United States
Investigative Site US013
San Diego, California, 92103
United States
Investigative Site US060
San Diego, California, 92120
United States
Investigative Site US038
San Diego, California, 92121
United States
Investigative Site US059
Aurora, Colorado, 80045
United States
Investigative Site US056
Wilmington, Delaware, 19810
United States
Investigative Site US045
Boynton Beach, Florida, 33437
United States
Investigative Site US029
Brandon, Florida, 33511
United States
Investigative Site US028
Fort Myers, Florida, 33912
United States
Investigative Site US016
Miami, Florida, 33142
United States
Investigative Site US027
Sanford, Florida, 32771
United States
Investigative Site US057
Sweetwater, Florida, 33172
United States
Investigative Site US061
Atlanta, Georgia, 30322
United States
Investigative Site US053
Atlanta, Georgia, 30331
United States
Investigative Site US019
Marietta, Georgia, 30060
United States
Investigative Site US026
Chicago, Illinois, 60657
United States
Investigative Site US042
Libertyville, Illinois, 60048
United States
Investigative Site US049
Clarksville, Indiana, 47129
United States
Investigative Site US052
West Lafayette, Indiana, 47906
United States
Investigative Site US001
Bowling Green, Kentucky, 42104
United States
Investigative Site US022
Louisville, Kentucky, 40241
United States
Investigative Site US050
Baton Rouge, Louisiana, 70809
United States
Investigative Site US046
Glenn Dale, Maryland, 20769
United States
Investigative Site US003
Boston, Massachusetts, 02115
United States
Investigative Site US010
Quincy, Massachusetts, 02169
United States
Investigative Site US051
Dearborn, Michigan, 48126
United States
Investigative Site US006
Minneapolis, Minnesota, 55455
United States
Investigative Site US021
Saint Paul, Minnesota, 55112
United States
Investigative Site US036
Saint Joseph, Missouri, 64506
United States
Investigative Site US034
New City, New York, 10956
United States
Investigative Site US017
New York, New York, 10023
United States
Investigative Site US023
Rochester, New York, 14623
United States
Investigative Site US014
Chapel Hill, North Carolina, 27516
United States
Investigative Site US025
Fargo, North Dakota, 58103
United States
Investigative Site US015
Bexley, Ohio, 43209
United States
Investigative Site US044
Cincinnati, Ohio, 45219
United States
Investigative Site US008
Columbus, Ohio, 43210
United States
Investigative Site US031
Mason, Ohio, 45040
United States
Investigative Site US048
Oklahoma City, Oklahoma, 73118
United States
Investigative Site US043
Danville, Pennsylvania, 17822
United States
Investigative Site US024
Charleston, South Carolina, 29425
United States
Investigative Site US041
Myrtle Beach, South Carolina, 29588
United States
Investigative Site US005
Murfreesboro, Tennessee, 37130
United States
Investigative Site US047
Nashville, Tennessee, 37215
United States
Investigative Site US032
Dallas, Texas, 75235
United States
Investigative Site US062
Dallas, Texas, 75390
United States
Investigative Site US035
El Paso, Texas, 79902
United States
Investigative Site US012
Plano, Texas, 75025
United States
Investigative Site US011
San Antonio, Texas, 78213
United States
Investigative Site US040
Layton, Utah, 84041
United States
Investigative Site US039
Ogden, Utah, 84405
United States
Investigative Site US037
Salt Lake City, Utah, 84107
United States
Investigative Site US058
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Incyte Corporation

  • Incyte Study Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-11
Study Completion Date2027-07-11

Study Record Updates

Study Start Date2025-06-11
Study Completion Date2027-07-11

Terms related to this study

Keywords Provided by Researchers

  • Hidradenitis suppurativa
  • skin disease
  • ruxolitinb cream

Additional Relevant MeSH Terms

  • Hidradenitis Suppurativa