Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS2)

Last updated: June 11, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

3

Condition

Hidradenitis Suppurativa

Rosacea

Scalp Disorders

Treatment

Vehicle Cream

Ruxolitinib Cream

Clinical Study ID

NCT06958211
INCB018424-325
2024-517633-40-00
  • Ages > 12
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 andbaseline 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 thevehicle-controlled period.

  • Agreement to NOT use topical antiseptics, including washes and leave-on products onthe areas affected by HS lesions during the vehicle-controlled period and Weeks 16to 20 of the extension period.

  • Further inclusion criteria apply.

Exclusion

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 theinvestigator.

  • Laboratory values outside of the protocol-defined criteria.

  • Pregnant or lactating participants, or those considering pregnancy during the periodof their study participation.

  • Further exclusion criteria apply.

Study Design

Total Participants: 450
Treatment Group(s): 2
Primary Treatment: Vehicle Cream
Phase: 3
Study Start date:
June 11, 2025
Estimated Completion Date:
July 11, 2027

Connect with a study center

  • Investigative Site BE204

    Brussels, 01070
    Belgium

    Site Not Available

  • Investigative Site BE201

    Gent, 09000
    Belgium

    Site Not Available

  • Investigative Site BE203

    Gent, 09910
    Belgium

    Site Not Available

  • Investigative Site BE202

    Leuven, 03000
    Belgium

    Site Not Available

  • Investigative Site BG201

    Sevlievo, 05400
    Bulgaria

    Site Not Available

  • Investigative Site BG202

    Sofia, 01431
    Bulgaria

    Site Not Available

  • Investigative Site BG203

    Sofia, 01592
    Bulgaria

    Site Not Available

  • Investigative Site CA209

    Edmonton, Alberta T5K 1X3
    Canada

    Site Not Available

  • Investigative Site CA201

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • Investigative Site CA207

    Fredericton, New Brunswick E3B 1G9
    Canada

    Site Not Available

  • Investigative Site CA202

    Hamilton, Ontario L8L 3C3
    Canada

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  • Investigative Site CA203

    London, Ontario N6H 5L5
    Canada

    Site Not Available

  • Investigative Site CA204

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • Investigative Site CA205

    Mississauga, Ontario L4W 0C2
    Canada

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  • Investigative Site CA208

    Saskatoon, Saskatchewan S7K 0H6
    Canada

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  • Investigative Site CA206

    St. John's, A1E 1V4
    Canada

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  • Investigative Site FR201

    Reims, 51100
    France

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  • Investigative Site FR203

    Rouen Cedex, 76031
    France

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  • Investigative Site FR204

    Saint Etienne Cedex 2, 42055
    France

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  • Investigative Site FR202

    Toulouse Cedex 9, 31059
    France

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  • Investigative Site DE207

    Bad Bentheim, 48455
    Germany

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  • Investigative Site DE201

    Frankfurt Am Main, 60590
    Germany

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  • Investigative Site DE206

    Gottingen, 37075
    Germany

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  • Investigative Site DE202

    Hannover, 30519
    Germany

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  • Investigative Site DE203

    Kiel, 24105
    Germany

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  • Investigative Site DE205

    Langenau, 89129
    Germany

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  • Investigative Site DE204

    Mainz, 55131
    Germany

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  • Investigative Site NL203

    Amsterdam, 1081GN
    Netherlands

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    Bergen Op Zoom, 4624 VT
    Netherlands

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  • Investigative Site NL201

    Rotterdam, 3015 CE
    Netherlands

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  • Investigative Site PL202

    Ostrowiec Swietokrzyski, 27-400
    Poland

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  • Investigative Site PL204

    Poznan, 60-309
    Poland

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  • Investigative Site PL201

    Rzeszow, 35-055
    Poland

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    Wrocaw, 54144
    Poland

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  • Investigative Site ES205

    Barcelona, 08041
    Spain

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    Barcelona, 08402
    Spain

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    Esplugues de Llobregat, 08950
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    Granada, 18014
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    Las Palmas de Gran Canaria, 35010
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    Madrid, 28041
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    Manises, 46940
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    Santiago de Compostela, 15706
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    Birmingham, Alabama 35244
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    Birmingham, Alabama 35203
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    Montgomery, Alabama 36117
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    Phoenix, Arizona 85006
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    Phoenix, Arizona 85037
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    Scottsdale, Arizona 85255
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    Tucson, Arizona 85718
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    Encino, California 91436
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    Fountain Valley, California 92708
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    Los Angeles, California 90045
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    Los Angeles, California 90056
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    Northridge, California 91325
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    Tustin, California 92780
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    Castle Rock, Colorado 80109
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  • Investigative Site US252

    Farmington, Connecticut 06030
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    Boca Raton, Florida 33486
    United States

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  • Investigative Site US203

    Hialeah, Florida 33012-3618
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    Jacksonville, Florida 32256
    United States

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  • Investigative Site US206

    Maitland, Florida 32751
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  • Investigative Site US202

    Miami, Florida 33173
    United States

    Active - Recruiting

  • Investigative Site US223

    Miami, Florida 33136
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    Miami, Florida 33147
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  • Investigative Site US214

    Tampa, Florida 33614
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    Tampa, Florida 33612
    United States

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    Atlanta, Georgia 30328
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    Columbus, Georgia 31904
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  • Investigative Site US233

    Ketchum, Idaho 83340
    United States

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    Skokie, Illinois 60077
    United States

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  • Investigative Site US205

    Plainfield, Indiana 46168
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    Lake Charles, Louisiana 70601
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    New Orleans, Louisiana 70012
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    New Orleans, Louisiana 70115
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    New Orleans, Louisiana 70112
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    Gambrills, Maryland 21054
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    Marriottsville, Maryland 21104
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    Brighton, Massachusetts 02135
    United States

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    Marlborough, Massachusetts 01752
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    Worcester, Massachusetts 01655
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    Ann Arbor, Michigan 48103
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    Auburn Hills, Michigan 48326
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  • Investigative Site US255

    Saint Peter, Minnesota 56082
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  • Investigative Site US251

    Saint Louis, Missouri 63110
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  • Investigative Site US212

    Missoula, Montana 59804
    United States

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  • Investigative Site US216

    Las Vegas, Nevada 89148
    United States

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  • Investigative Site US235

    Hoboken, New Jersey 07030
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  • Investigative Site US217

    Albuquerque, New Mexico 87131-0001
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    Brooklyn, New York 11203
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  • Investigative Site US269

    Fairport, New York 14450
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  • Investigative Site US213

    Kew Gardens, New York 11415
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  • Investigative Site US246

    New Hyde Park, New York 11042
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  • Investigative Site US242

    New York, New York 10075
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  • Investigative Site US245

    Rochester, New York 14642
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  • Investigative Site US259

    Huntersville, North Carolina 28078
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  • Investigative Site US263

    Winston-Salem, North Carolina 27104
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  • Investigative Site US249

    Columbus, Ohio 43213
    United States

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  • Investigative Site US243

    Dublin, Ohio 43016
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  • Investigative Site US228

    Mayfield Heights, Ohio 44124
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  • Investigative Site US204

    Portland, Oregon 97201
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  • Investigative Site US226

    Plymouth Meeting, Pennsylvania 19462
    United States

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  • Investigative Site US256

    Bluffton, South Carolina 29910
    United States

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  • Investigative Site US267

    Mount Pleasant, South Carolina 29464
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  • Investigative Site US260

    Cypress, Texas 77433
    United States

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  • Investigative Site US270

    Prosper, Texas 75078
    United States

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  • Investigative Site US232

    Sugar Land, Texas 77479
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  • Investigative Site US248

    Arlington, Virginia 22206
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  • Investigative Site US209

    Danville, Virginia 24541
    United States

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  • Investigative Site US229

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Investigative Site US265

    Seattle, Washington 98105
    United States

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  • Investigative Site US224

    Spokane, Washington 99202
    United States

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  • Investigative Site US210

    Milwaukee, Wisconsin 53226
    United States

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