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

Purpose

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

Condition

  • Hidradenitis Suppurativa

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 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. - Further inclusion criteria apply.

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 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. - Further exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ruxolitinib 1.5 % Cream 		Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol.
  • Drug: Ruxolitinib Cream
    Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Placebo Comparator
Vehicle Cream 		Participants received vehicle cream, applied topically to the affected area as defined by the protocol.
  • Drug: Vehicle Cream
    Matching vehicle cream applied topically to the affected area as a thin film twice daily.

Recruiting Locations

Investigative Site US257
Birmingham 4049979, Alabama 4829764 35203

Investigative Site US218
Birmingham 4049979, Alabama 4829764 35244

Investigative Site US239
Montgomery 4076784, Alabama 4829764 36117

Investigative Site US215
Phoenix 5308655, Arizona 5551752 85006

Investigative Site US261
Phoenix 5308655, Arizona 5551752 85037

Investigative Site US262
Encino 5346649, California 5332921 91436

Investigative Site US222
Fountain Valley 5350207, California 5332921 92708

Investigative Site US211
Los Angeles 5368361, California 5332921 90045

Investigative Site US237
Los Angeles 5368361, California 5332921 90056

Investigative Site US234
Northridge 5377985, California 5332921 91325

Investigative Site US250
Santa Ana 5392900, California 5332921 92706

Investigative Site US244
Castle Rock 5416329, Colorado 5417618 80109

Investigative Site US252
Cromwell 4832121, Connecticut 4831725 06416

Investigative Site US208
Boca Raton 4148411, Florida 4155751 33486

Investigative Site US203
Hialeah 4158476, Florida 4155751 33012-3618

Investigative Site US258
Jacksonville 4160021, Florida 4155751 32216

Investigative Site US206
Maitland 4163220, Florida 4155751 32751

Investigative Site US223
Miami 4164138, Florida 4155751 33136

Investigative Site US241
Miami 4164138, Florida 4155751 33147

Investigative Site US202
Miami 4164138, Florida 4155751 33173

Investigative Site US214
Tampa 4174757, Florida 4155751 33609

Investigative Site US247
Tampa 4174757, Florida 4155751 33612

Investigative Site US231
Columbus 4188985, Georgia 4197000 31904

Investigative Site US225
Sandy Springs 4221333, Georgia 4197000 30328

Investigative Site US207
Skokie 4911600, Illinois 4896861 60077

Investigative Site US205
Plainfield 4263108, Indiana 4921868 46168

Investigative Site US264
Lake Charles 4330236, Louisiana 4331987 70601

Investigative Site US266
New Orleans 4335045, Louisiana 4331987 70115

Investigative Site US254
Gambrills 4355899, Maryland 4361885 21054

Investigative Site US201
Marriottsville 4361736, Maryland 4361885 21104

Investigative Site US253
Milford 4943958, Massachusetts 6254926 01757

Investigative Site US227
Needham 4945055, Massachusetts 6254926 02492

Investigative Site US238
Ann Arbor 4984247, Michigan 5001836 48103

Investigative Site US230
Auburn Hills 4984565, Michigan 5001836 48326

Investigative Site US251
St Louis 4407066, Missouri 4398678 63110-1010

Investigative Site US271
Wildwood 4414749, Missouri 4398678 63040

Investigative Site US212
Missoula 5666639, Montana 5667009 59804

Investigative Site US216
Las Vegas 5506956, Nevada 5509151 89145

Investigative Site US235
Hoboken 5099133, New Jersey 5101760 07030

Investigative Site US217
Albuquerque 5454711, New Mexico 5481136 87102

Investigative Site US219
Brooklyn 5110302, New York 5128638 11203

Investigative Site US269
Fairport 5116815, New York 5128638 14450

Investigative Site US213
Kew Gardens 5123344, New York 5128638 11415

Investigative Site US242
New York 5128581, New York 5128638 10075

Investigative Site US259
Huntersville 4472370, North Carolina 4482348 28078

Investigative Site US228
Cleveland 5150529, Ohio 5165418 44124

Investigative Site US243
Columbus 4509177, Ohio 5165418 43213

Investigative Site US249
Columbus 4509177, Ohio 5165418 43213

Investigative Site US204
Portland 5746545, Oregon 5744337 97201

Investigative Site US226
Plymouth Meeting 5206666, Pennsylvania 6254927 19462

Investigative Site US256
Bluffton 4571722, South Carolina 4597040 29910

Investigative Site US267
Mt. Pleasant 4588165, South Carolina 4597040 29464

Investigative Site US255
Austin 4671654, Texas 4736286 78759

Investigative Site US260
Cypress 4684724, Texas 4736286 77429

Investigative Site US270
Prosper 4720833, Texas 4736286 75078

Investigative Site US232
Sugar Land 4734825, Texas 4736286 77479

Investigative Site US248
Arlington 4744709, Virginia 6254928 22206

Investigative Site US209
Danville 4755280, Virginia 6254928 24541

Investigative Site US229
Norfolk 4776222, Virginia 6254928 23502

Investigative Site US224
Spokane 5811696, Washington 5815135 99202

More Details

NCT ID
NCT06958211
Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com

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Vanderbilt University Medical Center