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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ruxolitinib 1.5 % Cream |
Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol. |
|
|
Placebo Comparator Vehicle Cream |
Participants received vehicle cream, applied topically to the affected area as defined by the protocol. |
|
Recruiting Locations
Investigative Site US257
Birmingham 4049979, Alabama 4829764 35203
Birmingham 4049979, Alabama 4829764 35203
Investigative Site US218
Birmingham 4049979, Alabama 4829764 35244
Birmingham 4049979, Alabama 4829764 35244
Investigative Site US239
Montgomery 4076784, Alabama 4829764 36117
Montgomery 4076784, Alabama 4829764 36117
Investigative Site US215
Phoenix 5308655, Arizona 5551752 85006
Phoenix 5308655, Arizona 5551752 85006
Investigative Site US261
Phoenix 5308655, Arizona 5551752 85037
Phoenix 5308655, Arizona 5551752 85037
Investigative Site US262
Encino 5346649, California 5332921 91436
Encino 5346649, California 5332921 91436
Investigative Site US222
Fountain Valley 5350207, California 5332921 92708
Fountain Valley 5350207, California 5332921 92708
Investigative Site US211
Los Angeles 5368361, California 5332921 90045
Los Angeles 5368361, California 5332921 90045
Investigative Site US237
Los Angeles 5368361, California 5332921 90056
Los Angeles 5368361, California 5332921 90056
Investigative Site US234
Northridge 5377985, California 5332921 91325
Northridge 5377985, California 5332921 91325
Investigative Site US250
Santa Ana 5392900, California 5332921 92706
Santa Ana 5392900, California 5332921 92706
Investigative Site US244
Castle Rock 5416329, Colorado 5417618 80109
Castle Rock 5416329, Colorado 5417618 80109
Investigative Site US252
Cromwell 4832121, Connecticut 4831725 06416
Cromwell 4832121, Connecticut 4831725 06416
Investigative Site US208
Boca Raton 4148411, Florida 4155751 33486
Boca Raton 4148411, Florida 4155751 33486
Investigative Site US203
Hialeah 4158476, Florida 4155751 33012-3618
Hialeah 4158476, Florida 4155751 33012-3618
Investigative Site US258
Jacksonville 4160021, Florida 4155751 32216
Jacksonville 4160021, Florida 4155751 32216
Investigative Site US206
Maitland 4163220, Florida 4155751 32751
Maitland 4163220, Florida 4155751 32751
Investigative Site US223
Miami 4164138, Florida 4155751 33136
Miami 4164138, Florida 4155751 33136
Investigative Site US241
Miami 4164138, Florida 4155751 33147
Miami 4164138, Florida 4155751 33147
Investigative Site US202
Miami 4164138, Florida 4155751 33173
Miami 4164138, Florida 4155751 33173
Investigative Site US214
Tampa 4174757, Florida 4155751 33609
Tampa 4174757, Florida 4155751 33609
Investigative Site US247
Tampa 4174757, Florida 4155751 33612
Tampa 4174757, Florida 4155751 33612
Investigative Site US231
Columbus 4188985, Georgia 4197000 31904
Columbus 4188985, Georgia 4197000 31904
Investigative Site US225
Sandy Springs 4221333, Georgia 4197000 30328
Sandy Springs 4221333, Georgia 4197000 30328
Investigative Site US207
Skokie 4911600, Illinois 4896861 60077
Skokie 4911600, Illinois 4896861 60077
Investigative Site US205
Plainfield 4263108, Indiana 4921868 46168
Plainfield 4263108, Indiana 4921868 46168
Investigative Site US264
Lake Charles 4330236, Louisiana 4331987 70601
Lake Charles 4330236, Louisiana 4331987 70601
Investigative Site US266
New Orleans 4335045, Louisiana 4331987 70115
New Orleans 4335045, Louisiana 4331987 70115
Investigative Site US254
Gambrills 4355899, Maryland 4361885 21054
Gambrills 4355899, Maryland 4361885 21054
Investigative Site US201
Marriottsville 4361736, Maryland 4361885 21104
Marriottsville 4361736, Maryland 4361885 21104
Investigative Site US253
Milford 4943958, Massachusetts 6254926 01757
Milford 4943958, Massachusetts 6254926 01757
Investigative Site US227
Needham 4945055, Massachusetts 6254926 02492
Needham 4945055, Massachusetts 6254926 02492
Investigative Site US238
Ann Arbor 4984247, Michigan 5001836 48103
Ann Arbor 4984247, Michigan 5001836 48103
Investigative Site US230
Auburn Hills 4984565, Michigan 5001836 48326
Auburn Hills 4984565, Michigan 5001836 48326
Investigative Site US251
St Louis 4407066, Missouri 4398678 63110-1010
St Louis 4407066, Missouri 4398678 63110-1010
Investigative Site US271
Wildwood 4414749, Missouri 4398678 63040
Wildwood 4414749, Missouri 4398678 63040
Investigative Site US212
Missoula 5666639, Montana 5667009 59804
Missoula 5666639, Montana 5667009 59804
Investigative Site US216
Las Vegas 5506956, Nevada 5509151 89145
Las Vegas 5506956, Nevada 5509151 89145
Investigative Site US235
Hoboken 5099133, New Jersey 5101760 07030
Hoboken 5099133, New Jersey 5101760 07030
Investigative Site US217
Albuquerque 5454711, New Mexico 5481136 87102
Albuquerque 5454711, New Mexico 5481136 87102
Investigative Site US219
Brooklyn 5110302, New York 5128638 11203
Brooklyn 5110302, New York 5128638 11203
Investigative Site US269
Fairport 5116815, New York 5128638 14450
Fairport 5116815, New York 5128638 14450
Investigative Site US213
Kew Gardens 5123344, New York 5128638 11415
Kew Gardens 5123344, New York 5128638 11415
Investigative Site US242
New York 5128581, New York 5128638 10075
New York 5128581, New York 5128638 10075
Investigative Site US259
Huntersville 4472370, North Carolina 4482348 28078
Huntersville 4472370, North Carolina 4482348 28078
Investigative Site US228
Cleveland 5150529, Ohio 5165418 44124
Cleveland 5150529, Ohio 5165418 44124
Investigative Site US243
Columbus 4509177, Ohio 5165418 43213
Columbus 4509177, Ohio 5165418 43213
Investigative Site US249
Columbus 4509177, Ohio 5165418 43213
Columbus 4509177, Ohio 5165418 43213
Investigative Site US204
Portland 5746545, Oregon 5744337 97201
Portland 5746545, Oregon 5744337 97201
Investigative Site US226
Plymouth Meeting 5206666, Pennsylvania 6254927 19462
Plymouth Meeting 5206666, Pennsylvania 6254927 19462
Investigative Site US256
Bluffton 4571722, South Carolina 4597040 29910
Bluffton 4571722, South Carolina 4597040 29910
Investigative Site US267
Mt. Pleasant 4588165, South Carolina 4597040 29464
Mt. Pleasant 4588165, South Carolina 4597040 29464
Investigative Site US255
Austin 4671654, Texas 4736286 78759
Austin 4671654, Texas 4736286 78759
Investigative Site US260
Cypress 4684724, Texas 4736286 77429
Cypress 4684724, Texas 4736286 77429
Investigative Site US270
Prosper 4720833, Texas 4736286 75078
Prosper 4720833, Texas 4736286 75078
Investigative Site US232
Sugar Land 4734825, Texas 4736286 77479
Sugar Land 4734825, Texas 4736286 77479
Investigative Site US248
Arlington 4744709, Virginia 6254928 22206
Arlington 4744709, Virginia 6254928 22206
Investigative Site US209
Danville 4755280, Virginia 6254928 24541
Danville 4755280, Virginia 6254928 24541
Investigative Site US229
Norfolk 4776222, Virginia 6254928 23502
Norfolk 4776222, Virginia 6254928 23502
Investigative Site US224
Spokane 5811696, Washington 5815135 99202
Spokane 5811696, Washington 5815135 99202
More Details
- Status
- Recruiting
- Sponsor
- Incyte Corporation