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

Last updated: June 25, 2025
Sponsor: Incyte Corporation
Overall Status: Active - Recruiting

Phase

3

Condition

Rosacea

Hidradenitis Suppurativa

Scalp Disorders

Treatment

Ruxolitinib Cream

Vehicle Cream

Clinical Study ID

NCT06959225
INCB018424-324
2024-517632-22-00
  • 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: 400
Treatment Group(s): 2
Primary Treatment: Ruxolitinib Cream
Phase: 3
Study Start date:
June 23, 2025
Estimated Completion Date:
July 11, 2027

Connect with a study center

  • Investigative Site BG002

    Sofia, 01407
    Bulgaria

    Site Not Available

  • Investigative Site BG003

    Sofia, 01463
    Bulgaria

    Site Not Available

  • Investigative Site BG001

    Stara Zagora, 06000
    Bulgaria

    Site Not Available

  • Investigative Site CA003

    Calgary, Alberta T3E 0B2
    Canada

    Site Not Available

  • Investigative Site CA004

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Investigative Site CA009

    Ottawa, Ontario K1K 4L2
    Canada

    Site Not Available

  • Investigative Site CA002

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • Investigative Site CA001

    Richmond Hill, Ontario L4C 9M7
    Canada

    Site Not Available

  • Investigative Site CA005

    Toronto, Ontario M4E 1R7
    Canada

    Site Not Available

  • Investigative Site CA007

    Toronto, Ontario M3B 0A7
    Canada

    Site Not Available

  • Investigative Site CA006

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Investigative Site CA008

    Sherbrooke, Quebec J1G 1X9
    Canada

    Site Not Available

  • Investigative Site FR002

    Bordeaux, 33000
    France

    Site Not Available

  • Investigative Site FR005

    Brest Cedex 2, 29609
    France

    Site Not Available

  • Investigative Site FR001

    Cedex 10, 75475
    France

    Site Not Available

  • Investigative Site FR004

    Nantes Cedex 1, 44093
    France

    Site Not Available

  • Investigative Site FR003

    Nice Cedex 3, 06200
    France

    Site Not Available

  • Investigative Site DE005

    Berlin, 13595
    Germany

    Site Not Available

  • Investigative Site DE006

    Berlin, 10117
    Germany

    Site Not Available

  • Investigative Site DE002

    Bochum, 44791
    Germany

    Site Not Available

  • Investigative Site DE004

    Darmstadt, 64283
    Germany

    Site Not Available

  • Investigative Site DE001

    Dresden, 01307
    Germany

    Site Not Available

  • Investigative Site DE003

    Erlangen, 91054
    Germany

    Site Not Available

  • Investigative Site DE007

    Hamburg, 20246
    Germany

    Site Not Available

  • Investigative Site DE008

    Lubeck, 23562
    Germany

    Site Not Available

  • Investigative Site IT001

    Catania, 95123
    Italy

    Site Not Available

  • Investigative Site IT005

    Cona, 44124
    Italy

    Site Not Available

  • Investigative Site IT009

    Firenze, 50122
    Italy

    Site Not Available

  • Investigative Site IT002

    Milan, 20122
    Italy

    Site Not Available

  • Investigative Site IT007

    Napoli, 80131
    Italy

    Site Not Available

  • Investigative Site IT004

    Roma, 00144
    Italy

    Site Not Available

  • Investigative Site IT006

    Roma, 00137
    Italy

    Site Not Available

  • Investigative Site IT003

    Rozzano, 20135
    Italy

    Site Not Available

  • Investigative Site IT008

    Torino, 10126
    Italy

    Site Not Available

  • Investigative Site PL002

    Lodz, 90-436
    Poland

    Site Not Available

  • Investigative Site PL003

    Torun, 87-100
    Poland

    Site Not Available

  • Investigative Site PL001

    Warszawa, 02-962
    Poland

    Site Not Available

  • Investigative Site PL004

    Wroclaw, 50-220
    Poland

    Site Not Available

  • Investigative Site ES004

    Alicante, 03010
    Spain

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  • Investigative Site ES005

    Badalona, 08916
    Spain

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  • Investigative Site ES003

    Barcelona, 08003
    Spain

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  • Investigative Site ES001

    Madrid, 28007
    Spain

    Site Not Available

  • Investigative Site ES002

    Madrid, 28040
    Spain

    Site Not Available

  • Investigative Site GB005

    Bristol, BS1 3NU
    United Kingdom

    Site Not Available

  • Investigative Site GB001

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • Investigative Site GB004

    Harrogate, HG2 7SX
    United Kingdom

    Site Not Available

  • Investigative Site GB002

    Ipswich, IP4 5PD
    United Kingdom

    Site Not Available

  • Investigative Site GB006

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Investigative Site GB003

    Redhill, RH1 5RH
    United Kingdom

    Site Not Available

  • Investigative Site US020

    Phoenix, Arizona 85008
    United States

    Site Not Available

  • Investigative Site US033

    Scottsdale, Arizona 85259
    United States

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  • Investigative Site US054

    Tempe, Arizona 85282
    United States

    Site Not Available

  • Investigative Site US002

    Fayetteville, Arkansas 72703
    United States

    Active - Recruiting

  • Investigative Site US055

    Chino, California 91710
    United States

    Site Not Available

  • Investigative Site US004

    Laguna Niguel, California 92677
    United States

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  • Investigative Site US007

    Los Angeles, California 90033
    United States

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  • Investigative Site US013

    San Diego, California 92103
    United States

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  • Investigative Site US038

    San Diego, California 92121
    United States

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  • Investigative Site US060

    San Diego, California 92120
    United States

    Site Not Available

  • Investigative Site US059

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Investigative Site US056

    Wilmington, Delaware 19810
    United States

    Site Not Available

  • Investigative Site US045

    Boynton Beach, Florida 33437
    United States

    Site Not Available

  • Investigative Site US029

    Brandon, Florida 33511
    United States

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  • Investigative Site US028

    Fort Myers, Florida 33912
    United States

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  • Investigative Site US016

    Miami, Florida 33142
    United States

    Site Not Available

  • Investigative Site US027

    Sanford, Florida 32771
    United States

    Site Not Available

  • Investigative Site US057

    Sweetwater, Florida 33172
    United States

    Site Not Available

  • Investigative Site US053

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Investigative Site US061

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Investigative Site US019

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Investigative Site US026

    Chicago, Illinois 60657
    United States

    Site Not Available

  • Investigative Site US042

    Libertyville, Illinois 60048
    United States

    Site Not Available

  • Investigative Site US049

    Clarksville, Indiana 47129
    United States

    Site Not Available

  • Investigative Site US052

    West Lafayette, Indiana 47906
    United States

    Site Not Available

  • Investigative Site US001

    Bowling Green, Kentucky 42104
    United States

    Site Not Available

  • Investigative Site US022

    Louisville, Kentucky 40241
    United States

    Site Not Available

  • Investigative Site US050

    Baton Rouge, Louisiana 70809
    United States

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  • Investigative Site US046

    Glenn Dale, Maryland 20769
    United States

    Site Not Available

  • Investigative Site US003

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Investigative Site US010

    Quincy, Massachusetts 02169
    United States

    Active - Recruiting

  • Investigative Site US051

    Dearborn, Michigan 48126
    United States

    Site Not Available

  • Investigative Site US006

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Investigative Site US021

    Saint Paul, Minnesota 55112
    United States

    Site Not Available

  • Investigative Site US036

    Saint Joseph, Missouri 64506
    United States

    Active - Recruiting

  • Investigative Site US034

    New City, New York 10956
    United States

    Site Not Available

  • Investigative Site US017

    New York, New York 10023
    United States

    Site Not Available

  • Investigative Site US018

    New York, New York 10003
    United States

    Site Not Available

  • Investigative Site US023

    Rochester, New York 14623
    United States

    Active - Recruiting

  • Investigative Site US014

    Chapel Hill, North Carolina 27516
    United States

    Site Not Available

  • Investigative Site US025

    Fargo, North Dakota 58103
    United States

    Active - Recruiting

  • Investigative Site US015

    Bexley, Ohio 43209
    United States

    Site Not Available

  • Investigative Site US044

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Investigative Site US008

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Investigative Site US031

    Mason, Ohio 45040
    United States

    Site Not Available

  • Investigative Site US048

    Oklahoma City, Oklahoma 73118
    United States

    Site Not Available

  • Investigative Site US043

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • Investigative Site US024

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Investigative Site US041

    Myrtle Beach, South Carolina 29588
    United States

    Site Not Available

  • Investigative Site US005

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Investigative Site US047

    Nashville, Tennessee 37215
    United States

    Site Not Available

  • Investigative Site US032

    Dallas, Texas 75235
    United States

    Site Not Available

  • Investigative Site US062

    Dallas, Texas 75390
    United States

    Site Not Available

  • Investigative Site US035

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • Investigative Site US012

    Plano, Texas 75025
    United States

    Site Not Available

  • Investigative Site US011

    San Antonio, Texas 78213
    United States

    Active - Recruiting

  • Investigative Site US040

    Layton, Utah 84041
    United States

    Site Not Available

  • Investigative Site US039

    Ogden, Utah 84405
    United States

    Site Not Available

  • Investigative Site US037

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • Investigative Site US058

    Seattle, Washington 98105
    United States

    Site Not Available

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