A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
Status: Recruiting
Location: See all (111) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in participants with hidradenitis suppurativa.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• 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.
Locations
United States
Alabama
Investigative Site US218
RECRUITING
Birmingham
Investigative Site US257
RECRUITING
Birmingham
Investigative Site US239
RECRUITING
Montgomery
Arizona
Investigative Site US215
RECRUITING
Phoenix
Investigative Site US261
RECRUITING
Phoenix
Investigative Site US221
WITHDRAWN
Scottsdale
Investigative Site US240
NOT_YET_RECRUITING
Tucson
California
Investigative Site US262
RECRUITING
Encino
Investigative Site US222
RECRUITING
Fountain Valley
Investigative Site US211
RECRUITING
Los Angeles
Investigative Site US237
RECRUITING
Los Angeles
Investigative Site US234
RECRUITING
Northridge
Investigative Site US250
RECRUITING
Santa Ana
Colorado
Investigative Site US244
RECRUITING
Castle Rock
Connecticut
Investigative Site US252
RECRUITING
Cromwell
Florida
Investigative Site US208
RECRUITING
Boca Raton
Investigative Site US203
RECRUITING
Hialeah
Investigative Site US258
RECRUITING
Jacksonville
Investigative Site US206
RECRUITING
Maitland
Investigative Site US202
RECRUITING
Miami
Investigative Site US223
RECRUITING
Miami
Investigative Site US241
RECRUITING
Miami
Investigative Site US214
RECRUITING
Tampa
Investigative Site US247
RECRUITING
Tampa
Georgia
Investigative Site US231
RECRUITING
Columbus
Investigative Site US225
RECRUITING
Sandy Springs
Idaho
Investigative Site US233
WITHDRAWN
Ketchum
Illinois
Investigative Site US207
RECRUITING
Skokie
Indiana
Investigative Site US205
RECRUITING
Plainfield
Louisiana
Investigative Site US264
RECRUITING
Lake Charles
Investigative Site US236
NOT_YET_RECRUITING
New Orleans
Investigative Site US266
RECRUITING
New Orleans
Investigative Site US326
NOT_YET_RECRUITING
New Orleans
Massachusetts
Investigative Site US253
RECRUITING
Milford
Investigative Site US227
RECRUITING
Needham
Investigative Site US268
NOT_YET_RECRUITING
Worcester
Maryland
Investigative Site US254
RECRUITING
Gambrills
Investigative Site US201
RECRUITING
Marriottsville
Michigan
Investigative Site US238
RECRUITING
Ann Arbor
Investigative Site US230
RECRUITING
Auburn Hills
Missouri
Investigative Site US251
RECRUITING
St Louis
Investigative Site US271
RECRUITING
Wildwood
Montana
Investigative Site US212
RECRUITING
Missoula
North Carolina
Investigative Site US259
RECRUITING
Huntersville
Investigative Site US263
NOT_YET_RECRUITING
Winston-salem
New Jersey
Investigative Site US235
RECRUITING
Hoboken
New Mexico
Investigative Site US217
RECRUITING
Albuquerque
Nevada
Investigative Site US216
RECRUITING
Las Vegas
New York
Investigative Site US219
RECRUITING
Brooklyn
Investigative Site US246
NOT_YET_RECRUITING
Elmhurst
Investigative Site US269
RECRUITING
Fairport
Investigative Site US213
RECRUITING
Kew Gardens
Investigative Site US242
RECRUITING
New York
Investigative Site US245
NOT_YET_RECRUITING
Rochester
Ohio
Investigative Site US228
RECRUITING
Cleveland
Investigative Site US243
RECRUITING
Columbus
Investigative Site US249
RECRUITING
Columbus
Oregon
Investigative Site US204
RECRUITING
Portland
Pennsylvania
Investigative Site US226
RECRUITING
Plymouth Meeting
South Carolina
Investigative Site US256
RECRUITING
Bluffton
Investigative Site US267
RECRUITING
Mt. Pleasant
Texas
Investigative Site US255
RECRUITING
Austin
Investigative Site US260
RECRUITING
Cypress
Investigative Site US270
RECRUITING
Prosper
Investigative Site US232
RECRUITING
Sugar Land
Virginia
Investigative Site US248
RECRUITING
Arlington
Investigative Site US209
RECRUITING
Danville
Investigative Site US229
RECRUITING
Norfolk
Washington
Investigative Site US265
NOT_YET_RECRUITING
Seattle
Investigative Site US224
RECRUITING
Spokane
Wisconsin
Investigative Site US210
NOT_YET_RECRUITING
Milwaukee
Other Locations
Belgium
Investigative Site BE204
NOT_YET_RECRUITING
Brussels
Investigative Site BE201
NOT_YET_RECRUITING
Ghent
Investigative Site BE203
NOT_YET_RECRUITING
Ghent
Investigative Site BE202
NOT_YET_RECRUITING
Leuven
Bulgaria
Investigative Site BG201
RECRUITING
Sevlievo
Investigative Site BG202
RECRUITING
Sofia
Investigative Site BG203
RECRUITING
Sofia
Canada
Investigative Site CA209
RECRUITING
Edmonton
Investigative Site CA207
RECRUITING
Fredericton
Investigative Site CA202
RECRUITING
Hamilton
Investigative Site CA203
RECRUITING
London
Investigative Site CA204
RECRUITING
Markham
Investigative Site CA205
RECRUITING
Mississauga
Investigative Site CA208
RECRUITING
Saskatoon
Investigative Site CA206
NOT_YET_RECRUITING
St. John's
Investigative Site CA201
RECRUITING
Winnipeg
France
Investigative Site FR201
RECRUITING
Reims
Investigative Site FR203
RECRUITING
Rouen
Investigative Site FR204
RECRUITING
Saint-etienne
Investigative Site FR202
RECRUITING
Toulouse
Germany
Investigative Site DE207
RECRUITING
Bad Bentheim
Investigative Site DE206
RECRUITING
Göttingen
Investigative Site DE202
RECRUITING
Hanover
Investigative Site DE203
RECRUITING
Kiel
Investigative Site DE205
RECRUITING
Langenau
Investigative Site DE204
RECRUITING
Merzig
Netherlands
Investigative Site NL203
NOT_YET_RECRUITING
Amsterdam
Investigative Site NL201
RECRUITING
Rotterdam
Poland
Investigative Site PL202
RECRUITING
Lublin
Investigative Site LP204
RECRUITING
Poznan
Investigative Site PL201
RECRUITING
Rzeszów
Investigative Site PL203
RECRUITING
Wroclaw
Spain
Investigative Site ES205
RECRUITING
Barcelona
Investigative Site ES208
RECRUITING
Esplugues De Llobregat
Investigative Site ES201
RECRUITING
Granada
Investigative Site ES206
NOT_YET_RECRUITING
Granollers
Investigative Site ES202
NOT_YET_RECRUITING
Las Palmas De Gran Canaria
Investigative Site ES203
RECRUITING
Madrid
Investigative Site ES207
RECRUITING
Manises
Investigative Site ES204
NOT_YET_RECRUITING
Santiago De Compostela
Contact Information
Primary
Incyte Corporation Call Center (US)
medinfo@incyte.com
1.855.463.3463
Backup
Incyte Corporation Call Center (ex-US)
eumedinfo@incyte.com
+800 00027423
Time Frame
Start Date:2025-06-12
Estimated Completion Date:2027-07-11
Participants
Target number of participants:450
Treatments
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.