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Purpose

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

Condition

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, Alabama 35203

Investigative Site US218
Birmingham, Alabama 35244

Investigative Site US239
Montgomery, Alabama 36117

Investigative Site US215
Phoenix, Arizona 85006

Investigative Site US261
Phoenix, Arizona 85037

Investigative Site US240
Tucson, Arizona 85718

Investigative Site US262
Encino, California 91436

Investigative Site US222
Fountain Valley, California 92708

Investigative Site US211
Los Angeles, California 90045

Investigative Site US237
Los Angeles, California 90056

Investigative Site US234
Northridge, California 91325

Investigative Site US250
Santa Ana, California 92706

Investigative Site US244
Castle Rock, Colorado 80109

Investigative Site US252
Cromwell, Connecticut 06416

Investigative Site US208
Boca Raton, Florida 33486

Investigative Site US203
Hialeah, Florida 33012-3618

Investigative Site US258
Jacksonville, Florida 32216

Investigative Site US206
Maitland, Florida 32751

Investigative Site US223
Miami, Florida 33136

Investigative Site US241
Miami, Florida 33147

Investigative Site US202
Miami, Florida 33173

Investigative Site US214
Tampa, Florida 33609

Investigative Site US247
Tampa, Florida 33612

Investigative Site US231
Columbus, Georgia 31904

Investigative Site US225
Sandy Springs, Georgia 30328

Investigative Site US207
Skokie, Illinois 60077

Investigative Site US205
Plainfield, Indiana 46168

Investigative Site US264
Lake Charles, Louisiana 70601

Investigative Site US266
New Orleans, Louisiana 70115

Investigative Site US254
Gambrills, Maryland 21054

Investigative Site US201
Marriottsville, Maryland 21104

Investigative Site US253
Milford, Massachusetts 01757

Investigative Site US227
Needham, Massachusetts 02492

Investigative Site US238
Ann Arbor, Michigan 48103

Investigative Site US230
Auburn Hills, Michigan 48326

Investigative Site US251
St Louis, Missouri 63110-1010

Investigative Site US271
Wildwood, Missouri 63040

Investigative Site US212
Missoula, Montana 59804

Investigative Site US216
Las Vegas, Nevada 89145

Investigative Site US235
Hoboken, New Jersey 07030

Investigative Site US217
Albuquerque, New Mexico 87102

Investigative Site US219
Brooklyn, New York 11203

Investigative Site US246
Elmhurst, New York 11373

Investigative Site US269
Fairport, New York 14450

Investigative Site US213
Kew Gardens, New York 11415

Investigative Site US242
New York, New York 10075

Investigative Site US245
Rochester, New York 14620

Investigative Site US259
Huntersville, North Carolina 28078

Investigative Site US263
Winston-Salem, North Carolina 27104

Investigative Site US228
Cleveland, Ohio 44124

Investigative Site US243
Columbus, Ohio 43213

Investigative Site US249
Columbus, Ohio 43213

Investigative Site US204
Portland, Oregon 97201

Investigative Site US226
Plymouth Meeting, Pennsylvania 19462

Investigative Site US256
Bluffton, South Carolina 29910

Investigative Site US267
Mt. Pleasant, South Carolina 29464

Investigative Site US255
Austin, Texas 78759

Investigative Site US260
Cypress, Texas 77429

Investigative Site US270
Prosper, Texas 75078

Investigative Site US232
Sugar Land, Texas 77479

Investigative Site US248
Arlington, Virginia 22206

Investigative Site US209
Danville, Virginia 24541

Investigative Site US229
Norfolk, Virginia 23502

Investigative Site US265
Seattle, Washington 98105

Investigative Site US224
Spokane, Washington 99202

Investigative Site US210
Milwaukee, Wisconsin 53226

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.