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

NCT06958211 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: INCB018424-3252024-517633-40-00
• Study Type: interventional
• Target: 550
• Locations: 9 countries
• Sites: 107

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

Vehicle Cream DRUG

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

Vehicle Cream

Ruxolitinib Cream DRUG

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

Ruxolitinib 1.5 % 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 (107)

Investigative Site US257

Birmingham, Alabama, 35203, United States

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Investigative Site US218

Birmingham, Alabama, 35244, United States

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Investigative Site US239

Montgomery, Alabama, 36117, United States

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Investigative Site US215

Phoenix, Arizona, 85006, United States

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Investigative Site US261

Phoenix, Arizona, 85037, United States

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Investigative Site US240

Tucson, Arizona, 85718, United States

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Investigative Site US262

Encino, California, 91436, United States

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Investigative Site US222

Fountain Valley, California, 92708, United States

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Investigative Site US211

Los Angeles, California, 90045, United States

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Investigative Site US237

Los Angeles, California, 90056, United States

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Investigative Site US234

Northridge, California, 91325, United States

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Investigative Site US250

Santa Ana, California, 92706, United States

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Investigative Site US244

Castle Rock, Colorado, 80109, United States

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Investigative Site US252

Cromwell, Connecticut, 06416, United States

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Investigative Site US208

Boca Raton, Florida, 33486, United States

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Investigative Site US203

Hialeah, Florida, 33012-3618, United States

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Investigative Site US258

Jacksonville, Florida, 32216, United States

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Investigative Site US206

Maitland, Florida, 32751, United States

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Investigative Site US223

Miami, Florida, 33136, United States

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Investigative Site US241

Miami, Florida, 33147, United States

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Investigative Site US202

Miami, Florida, 33173, United States

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Investigative Site US214

Tampa, Florida, 33609, United States

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Investigative Site US247

Tampa, Florida, 33612, United States

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Investigative Site US231

Columbus, Georgia, 31904, United States

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Investigative Site US225

Sandy Springs, Georgia, 30328, United States

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Investigative Site US207

Skokie, Illinois, 60077, United States

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Investigative Site US205

Plainfield, Indiana, 46168, United States

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Investigative Site US264

Lake Charles, Louisiana, 70601, United States

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Investigative Site US266

New Orleans, Louisiana, 70115, United States

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Investigative Site US254

Gambrills, Maryland, 21054, United States

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Investigative Site US201

Marriottsville, Maryland, 21104, United States

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Investigative Site US253

Milford, Massachusetts, 01757, United States

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Investigative Site US227

Needham, Massachusetts, 02492, United States

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Investigative Site US268

Worcester, Massachusetts, 01605, United States

NOT YET RECRUITING

Investigative Site US238

Ann Arbor, Michigan, 48103, United States

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Investigative Site US230

Auburn Hills, Michigan, 48326, United States

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Investigative Site US251

St Louis, Missouri, 63110-1010, United States

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Investigative Site US271

Wildwood, Missouri, 63040, United States

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Investigative Site US212

Missoula, Montana, 59804, United States

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Investigative Site US216

Las Vegas, Nevada, 89145, United States

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Investigative Site US235

Hoboken, New Jersey, 07030, United States

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Investigative Site US217

Albuquerque, New Mexico, 87102, United States

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Investigative Site US219

Brooklyn, New York, 11203, United States

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Investigative Site US246

Elmhurst, New York, 11373, United States

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Investigative Site US269

Fairport, New York, 14450, United States

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Investigative Site US213

Kew Gardens, New York, 11415, United States

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Investigative Site US242

New York, New York, 10075, United States

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Investigative Site US245

Rochester, New York, 14620, United States

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Investigative Site US259

Huntersville, North Carolina, 28078, United States

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Investigative Site US263

Winston-Salem, North Carolina, 27104, United States

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Investigative Site US228

Cleveland, Ohio, 44124, United States

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Investigative Site US243

Columbus, Ohio, 43213, United States

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Investigative Site US249

Columbus, Ohio, 43213, United States

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Investigative Site US204

Portland, Oregon, 97201, United States

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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

Mt. Pleasant, South Carolina, 29464, United States

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Investigative Site US255

Austin, Texas, 78759, United States

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Investigative Site US260

Cypress, Texas, 77429, 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, United States

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Investigative Site US248

Arlington, Virginia, 22206, United States

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Investigative Site US209

Danville, Virginia, 24541, United States

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Investigative Site US229

Norfolk, Virginia, 23502, United States

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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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Investigative Site BE204

Brussels, 01070, Belgium

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Investigative Site BE201

Ghent, 09000, Belgium

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Investigative Site BE203

Ghent, 09000, Belgium

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Investigative Site BE202

Leuven, 03000, Belgium

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Investigative Site BG201

Sevlievo, 05400, Bulgaria

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Investigative Site BG202

Sofia, 01431, Bulgaria

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Investigative Site BG203

Sofia, 01592, Bulgaria

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Investigative Site CA209

Edmonton, Alberta, T5K1X3, Canada

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Investigative Site CA201

Winnipeg, Manitoba, R3M 3Z4, Canada

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Investigative Site CA207

Fredericton, New Brunswick, E3B 1G9, Canada

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Investigative Site CA202

Hamilton, Ontario, L8L 3C3, Canada

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Investigative Site CA203

London, Ontario, N6H 5L5, Canada

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Investigative Site CA204

Markham, Ontario, L3P 1X3, Canada

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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, 76031, France

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Investigative Site FR204

Saint-Etienne, 42055, France

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Investigative Site FR202

Toulouse, 31059, France

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Investigative Site DE207

Bad Bentheim, 48455, Germany

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Investigative Site DE206

Göttingen, 37075, Germany

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Investigative Site DE202

Hanover, 30159, 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

Merzig, 66663, Germany

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Investigative Site NL203

Amsterdam, 1105 AZ, Netherlands

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Investigative Site NL201

Rotterdam, 3015 CE, Netherlands

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Investigative Site PL202

Lublin, 20-607, Poland

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Investigative Site LP204

Poznan, 60-309, Poland

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Investigative Site PL201

Rzeszów, 35-055, Poland

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Investigative Site PL203

Wroclaw, 54-144, Poland

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Investigative Site ES205

Barcelona, 08041, Spain

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Investigative Site ES208

Esplugues de Llobregat, 08950, Spain

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Investigative Site ES201

Granada, 18014, Spain

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Investigative Site ES206

Granollers, 08402, Spain

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Investigative Site ES202

Las Palmas de Gran Canaria, 35010, Spain

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Investigative Site ES203

Madrid, 28041, Spain

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Investigative Site ES207

Manises, 46940, Spain

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Investigative Site ES204

Santiago de Compostela, 15706, Spain

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Related Links

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

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 25, 2025
• First Posted: May 6, 2025
• Study Start: June 12, 2025
• Primary Completion (Estimated): October 9, 2026
• Study Completion (Estimated): July 11, 2027
• Last Updated: April 8, 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 (8); PL (4); FR (4); BU (3); CA (9); NL (2); BE (4); US (67); DE (6)