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

Last updated: August 22, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

3

Condition

Rosacea

Scalp Disorders

Hidradenitis Suppurativa

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 12, 2025
Estimated Completion Date:
July 11, 2027

Connect with a study center

  • Investigative Site BE204

    Brussels, 01070
    Belgium

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  • Investigative Site BE204

    Brussels 2800866, 01070
    Belgium

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  • Investigative Site BE201

    Gent, 09000
    Belgium

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    Gent, 09000
    Belgium

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  • Investigative Site BE201

    Ghent 2797656, 09000
    Belgium

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    Ghent 2797656, 09000
    Belgium

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  • Investigative Site BE202

    Leuven, 03000
    Belgium

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  • Investigative Site BE202

    Leuven 2792482, 03000
    Belgium

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  • Investigative Site BG201

    Sevlievo, 05400
    Bulgaria

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  • Investigative Site BG201

    Sevlievo 727337, 05400
    Bulgaria

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  • Investigative Site BG202

    Sofia, 01618
    Bulgaria

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  • Investigative Site BG203

    Sofia, 01592
    Bulgaria

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  • Investigative Site BG202

    Sofia 727011, 01431
    Bulgaria

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    Sofia 727011, 01592
    Bulgaria

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  • Investigative Site CA209

    Edmonton, Alberta T5K1X3
    Canada

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    Edmonton 5946768, Alberta 5883102 T5K1X3
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    Winnipeg, Manitoba R3M 3Z4
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    Winnipeg 6183235, Manitoba 6065171 R3M 3Z4
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    Fredericton, New Brunswick E3B 1G9
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    Fredericton 5957776, New Brunswick 6087430 E3B 1G9
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    Hamilton, Ontario L8L 3C3
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    London, Ontario N6H 5L5
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    Markham, Ontario L3P 1X3
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    Mississauga, Ontario L4W 0C2
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    Hamilton 5969782, Ontario 6093943 L8L 3C3
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    Mississauga 6075357, Ontario 6093943 L4W 0C2
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    Saskatoon, Saskatchewan S7K 0H6
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    St. John's, A1E 1V4
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    St. John's 6324733, A1E 1V4
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    Reims, 51100
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    Reims 2984114, 51100
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    Rouen 2982652, 76031
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    Rouen Cedex, 76031
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    Saint Etienne Cedex 2, 42055
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    Saint-Etienne 2980291, 42055
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    Toulouse 2972315, 31059
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    Toulouse Cedex 9, 31059
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    Bad Bentheim, 48455
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    Bad Bentheim 2953552, 48455
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    Frankfurt Am Main, 60590
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    Goettingen, 37075
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    Gottingen, 37075
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    Göttingen 2918632, 37075
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    Hannover, 30159
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    Hanover 2910831, 30159
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    Kiel, 24105
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    Kiel 2891122, 24105
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    Langenau, 89129
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    Langenau 2881259, 89129
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    Mainz, 55131
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    Merzig, 66663
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    Merzig 2871675, 66663
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    Amsterdam, 1081GN
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    Amsterdam 2759794, 1081GN
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    Bergen Op Zoom, 4624 VT
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    Rotterdam 2747891, 3015 CE
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    Lublin 765876, 20-607
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    Ostrowiec Swietokrzyski, 27-400
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    Poznan, 60-309
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    Poznan 3088171, 60-309
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    Wrocaw, 54144
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    Wrocław, 54-144
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    Las Palmas de Gran Canaria 2515270, 35010
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    Madrid 3117735, 28041
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    Manises, 46940
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    Manises 2514197, 46940
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    Santiago de Compostela, 15706
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    Santiago de Compostela 3109642, 15706
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    Los Angeles, California 90045
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    Los Angeles, California 90056
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    Santa Ana 5392900, California 5332921 92706
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    Cromwell 4832121, Connecticut 4831725 06416
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    Miami, Florida 33125
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    Miami, Florida 33147
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    Tampa, Florida 33609
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    Tampa, Florida 33612
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    Boca Raton 4148411, Florida 4155751 33486
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    Tampa 4174757, Florida 4155751 33612
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    Lake Charles, Louisiana 70601
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    New Orleans, Louisiana 70115
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    New Orleans, Louisiana 70112
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    Needham, Massachusetts 02492
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    Boston 4930956, Massachusetts 6254926 02114
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    Milford 4943958, Massachusetts 6254926 01757
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    Town And Country, Missouri 63017
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    Wildwood, Missouri 63040
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    St Louis 4407066, Missouri 4398678 63110
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    New York, New York 10003
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    Brooklyn 5110302, New York 5128638 11203
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    Columbus, Ohio 43213
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    Plymouth Meeting, Pennsylvania 19462
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    Bluffton 4571722, South Carolina 4597040 29910
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    United States

    Site Not Available

  • Investigative Site US229

    Norfolk 4776222, Virginia 6254928 23502
    United States

    Active - Recruiting

  • Investigative Site US265

    Seattle, Washington 98105
    United States

    Site Not Available

  • Investigative Site US224

    Spokane, Washington 99202
    United States

    Site Not Available

  • Investigative Site US265

    Seattle 5809844, Washington 5815135 98105
    United States

    Site Not Available

  • Investigative Site US224

    Spokane 5811696, Washington 5815135 99202
    United States

    Active - Recruiting

  • Investigative Site US210

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Investigative Site US210

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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