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

NCT06959225 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: INCB018424-3242024-517632-22-00
• Study Type: interventional
• Target: 550
• Locations: 8 countries
• Sites: 101

Brief Summary

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

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis suppurativa; skin disease; ruxolitinb cream

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who achieve Hidradenitis Suppurativa (HS) Clinical Response 75 (HiSCR75) from baseline

  HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and/or inflammatory nodule (AN) count with no increase from baseline in abscess or draining tunnel count.

  Week 16

Secondary Outcomes (35)

• Proportion of participants with ≥ 1 flare

  Up to 16 weeks

• Proportion of participants who achieve HiSCR50

  Week 16

• Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)3 among participants with baseline Skin Pain NRS score ≥ 3

  Week 16

• Treatment-IR Population: Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) from baseline

  Week 16

• Treatment-IR Population: Proportion of participants with ≥ 1 HS flare

  Up to 16 weeks

Study Arms (2)

Ruxolitinib 1.5 % Cream

EXPERIMENTAL

Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.

Drug: Ruxolitinib Cream

Vehicle Cream

PLACEBO COMPARATOR

Participants received vehicle cream, applied topically to the affected area as defined by the protocol.

Drug: Vehicle Cream

Interventions

Ruxolitinib Cream DRUG

Ruxolitinib cream applied topically to the affected area as a thin film twice daily.

Ruxolitinib 1.5 % Cream

Vehicle Cream DRUG

Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Vehicle Cream

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (101)

Investigative Site US020

Phoenix, Arizona, 85008, United States

RECRUITING

Investigative Site US033

Scottsdale, Arizona, 85259, United States

RECRUITING

Investigative Site US054

Tempe, Arizona, 85282, United States

RECRUITING

Investigative Site US002

Fayetteville, Arkansas, 72703, United States

RECRUITING

Investigative Site US055

Brea, California, 92821, United States

RECRUITING

Investigative Site US004

Laguna Niguel, California, 92677, United States

RECRUITING

Investigative Site US007

Los Angeles, California, 90033, United States

RECRUITING

Investigative Site US013

San Diego, California, 92103, United States

RECRUITING

Investigative Site US060

San Diego, California, 92120, United States

RECRUITING

Investigative Site US038

San Diego, California, 92121, United States

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Investigative Site US059

Aurora, Colorado, 80045, United States

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Investigative Site US045

Boynton Beach, Florida, 33437, United States

RECRUITING

Investigative Site US028

Fort Myers, Florida, 33912, United States

RECRUITING

Investigative Site US016

Miami, Florida, 33142, United States

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Investigative Site US027

Sanford, Florida, 32771, United States

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Investigative Site US057

Sweetwater, Florida, 33172, United States

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Investigative Site US029

Tampa, Florida, 33609, United States

RECRUITING

Investigative Site US061

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

Investigative Site US053

Atlanta, Georgia, 30331, United States

RECRUITING

Investigative Site US019

Marietta, Georgia, 30060, United States

RECRUITING

Investigative Site US026

Chicago, Illinois, 60657, United States

RECRUITING

Investigative Site US049

Clarksville, Indiana, 47129, United States

RECRUITING

Investigative Site US052

West Lafayette, Indiana, 47906, United States

RECRUITING

Investigative Site US001

Bowling Green, Kentucky, 42104, United States

RECRUITING

Investigative Site US022

Louisville, Kentucky, 40241, United States

RECRUITING

Investigative Site US050

Baton Rouge, Louisiana, 70809, United States

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Investigative Site US046

Glenn Dale, Maryland, 20769, United States

RECRUITING

Investigative Site US003

Boston, Massachusetts, 02115, United States

RECRUITING

Investigative Site US030

Boston, Massachusetts, 02215, United States

RECRUITING

Investigative Site US010

Quincy, Massachusetts, 02169, United States

RECRUITING

Investigative Site US051

Novi, Michigan, 48377, United States

NOT YET RECRUITING

Investigative Site US006

Minneapolis, Minnesota, 55455, United States

RECRUITING

Investigative Site US021

New Brighton, Minnesota, 55112, United States

RECRUITING

Investigative Site US036

Saint Joseph, Missouri, 64506, United States

RECRUITING

Investigative Site US034

New City, New York, 10956, United States

RECRUITING

Investigative Site US018

New York, New York, 10003, United States

RECRUITING

Investigative Site US017

New York, New York, 10023, United States

RECRUITING

Investigative Site US023

Rochester, New York, 14623, United States

RECRUITING

Investigative Site US014

Chapel Hill, North Carolina, 27516, United States

RECRUITING

Investigative Site US025

Fargo, North Dakota, 58103, United States

RECRUITING

Investigative Site US015

Bexley, Ohio, 43209, United States

RECRUITING

Investigative Site US044

Cincinnati, Ohio, 45219, United States

RECRUITING

Investigative Site US008

Columbus, Ohio, 43230, United States

RECRUITING

Investigative Site US031

Mason, Ohio, 45040, United States

RECRUITING

Investigative Site US048

Oklahoma City, Oklahoma, 73118, United States

RECRUITING

Investigative Site US043

Danville, Pennsylvania, 17822, United States

NOT YET RECRUITING

Investigative Site US056

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Investigative Site US024

Charleston, South Carolina, 29425, United States

RECRUITING

Investigative Site US041

Myrtle Beach, South Carolina, 29788, United States

RECRUITING

Investigative Site US047

Nashville, Tennessee, 37215, United States

RECRUITING

Investigative Site US062

Dallas, Texas, 75390, United States

RECRUITING

Investigative Site US035

El Paso, Texas, 79902, United States

RECRUITING

Investigative Site US032

Frisco, Texas, 75033, United States

RECRUITING

Investigative Site US012

Plano, Texas, 75025, United States

RECRUITING

Investigative Site US011

San Antonio, Texas, 78213, United States

RECRUITING

Investigative Site US040

Layton, Utah, 84041, United States

COMPLETED

Investigative Site US037

Murray, Utah, 84107, United States

RECRUITING

Investigative Site US039

Ogden, Utah, 84405, United States

COMPLETED

Investigative Site US058

Seattle, Washington, 98195, United States

RECRUITING

Investigative Site BG002

Sofia, 01407, Bulgaria

RECRUITING

Investigative Site BG003

Sofia, 01463, Bulgaria

RECRUITING

Investigative Site CA004

Calgary, Alberta, T2J 7E1, Canada

RECRUITING

Investigative Site CA003

Calgary, Alberta, T3E 0B2, Canada

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Investigative Site CA009

Ottawa, Ontario, K1K 4L2, Canada

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Investigative Site CA002

Peterborough, Ontario, K9J 5K2, Canada

RECRUITING

Investigative Site CA001

Richmond Hill, Ontario, L4B 1L1, Canada

RECRUITING

Investigative Site CA007

Toronto, Ontario, M3B 0A7, Canada

RECRUITING

Investigative Site CA005

Toronto, Ontario, M4E 1R7, Canada

RECRUITING

Investigative Site CA006

Waterloo, Ontario, N2J 1C4, Canada

RECRUITING

Investigative Site CA008

Sherbrooke, Quebec, J1G 1X9, Canada

RECRUITING

Investigative Site FR002

Bordeaux, 33000, France

RECRUITING

Investigative Site FR005

Brest, 29609, France

RECRUITING

Investigative Site FR004

Nantes, 44093, France

RECRUITING

Investigative Site FR003

Nice, 06200, France

RECRUITING

Investigative Site FR001

Paris, 75010, France

RECRUITING

Investigative Site DE006

Berlin, 10117, Germany

RECRUITING

Investigative Site DE005

Berlin, 13595, Germany

RECRUITING

Investigative Site DE002

Bochum, 44791, Germany

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Investigative Site DE004

Darmstadt, 64283, Germany

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Investigative Site DE001

Dresden, 01307, Germany

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Investigative Site DE003

Erlangen, 91054, Germany

RECRUITING

Investigative Site DE007

Hamburg, 20246, Germany

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Investigative Site DE008

Lübeck, 23538, Germany

RECRUITING

Investigative Site IT001

Catania, 95123, Italy

RECRUITING

Investigative Site IT005

Cona, 44124, Italy

RECRUITING

Investigative Site IT009

Florence, 50122, Italy

NOT YET RECRUITING

Investigative Site IT003

Milan, 20122, Italy

RECRUITING

Investigative Site IT007

Naples, 80131, Italy

RECRUITING

Investigative Site IT006

Roma, 00137, Italy

RECRUITING

Investigative Site IT004

Roma, 00144, Italy

RECRUITING

Investigative Site IT002

Rozzano, 20089, Italy

RECRUITING

Investigative Site IT008

Torino, 10126, Italy

NOT YET RECRUITING

Investigative Site PL002

Lodz, 90-436, Poland

RECRUITING

Investigative Site PL003

Torun, 87-100, Poland

RECRUITING

Investigative Site PL001

Warsaw, 02-962, Poland

RECRUITING

Investigative Site PL004

Wroclaw, 54-239, Poland

RECRUITING

Investigative Site ES004

Alicante, 03010, Spain

RECRUITING

Investigative Site ES005

Badalona, 08916, Spain

RECRUITING

Investigative Site ES003

Barcelona, 08003, Spain

RECRUITING

Investigative Site ES001

Madrid, 28009, Spain

RECRUITING

Investigative Site ES002

Madrid, 28040, Spain

RECRUITING

Related Links

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

MeSH Terms

Conditions

Hidradenitis Suppurativa; Skin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Incyte Study Monitor

  Incyte Corporation

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): October 9, 2026
• Study Completion (Estimated): July 11, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.

Locations

ES (5); US (59); PL (4); IT (9); CA (9); DE (8); BU (2); FR (5)