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 (106) 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
Arkansas
Investigative Site US002
RECRUITING
Fayetteville
Arizona
Investigative Site US020
RECRUITING
Phoenix
Investigative Site US033
RECRUITING
Scottsdale
Investigative Site US054
RECRUITING
Tempe
California
Investigative Site US055
RECRUITING
Brea
Investigative Site US004
RECRUITING
Laguna Niguel
Investigative Site US007
RECRUITING
Los Angeles
Investigative Site US013
RECRUITING
San Diego
Investigative Site US038
RECRUITING
San Diego
Investigative Site US060
RECRUITING
San Diego
Colorado
Investigative Site US059
NOT_YET_RECRUITING
Aurora
Florida
Investigative Site US045
RECRUITING
Boynton Beach
Investigative Site US028
RECRUITING
Fort Myers
Investigative Site US016
RECRUITING
Miami
Investigative Site US027
RECRUITING
Sanford
Investigative Site US057
RECRUITING
Sweetwater
Investigative Site US029
RECRUITING
Tampa
Georgia
Investigative Site US053
NOT_YET_RECRUITING
Atlanta
Investigative Site US061
NOT_YET_RECRUITING
Atlanta
Investigative Site US019
RECRUITING
Marietta
Illinois
Investigative Site US026
RECRUITING
Chicago
Indiana
Investigative Site US049
RECRUITING
Clarksville
Investigative Site US052
RECRUITING
West Lafayette
Kentucky
Investigative Site US001
RECRUITING
Bowling Green
Investigative Site US022
RECRUITING
Louisville
Louisiana
Investigative Site US050
RECRUITING
Baton Rouge
Massachusetts
Investigative Site US003
RECRUITING
Boston
Investigative Site US030
NOT_YET_RECRUITING
Boston
Investigative Site US010
RECRUITING
Quincy
Maryland
Investigative Site US046
RECRUITING
Glenn Dale
Michigan
Investigative Site US051
NOT_YET_RECRUITING
Detroit
Minnesota
Investigative Site US006
RECRUITING
Minneapolis
Investigative Site US021
RECRUITING
New Brighton
Missouri
Investigative Site US036
RECRUITING
Saint Joseph
North Carolina
Investigative Site US014
RECRUITING
Chapel Hill
North Dakota
Investigative Site US025
RECRUITING
Fargo
New York
Investigative Site US034
RECRUITING
New City
Investigative Site US017
RECRUITING
New York
Investigative Site US018
RECRUITING
New York
Investigative Site US023
RECRUITING
Rochester
Ohio
Investigative Site US015
RECRUITING
Bexley
Investigative Site US044
RECRUITING
Cincinnati
Investigative Site US008
RECRUITING
Columbus
Investigative Site US031
RECRUITING
Mason
Oklahoma
Investigative Site US048
RECRUITING
Oklahoma City
Pennsylvania
Investigative Site US043
NOT_YET_RECRUITING
Danville
Investigative Site US056
RECRUITING
Philadelphia
South Carolina
Investigative Site US024
RECRUITING
Charleston
Investigative Site US041
RECRUITING
Myrtle Beach
Tennessee
Investigative Site US005
NOT_YET_RECRUITING
Murfreesboro
Investigative Site US047
RECRUITING
Nashville
Texas
Investigative Site US062
RECRUITING
Dallas
Investigative Site US035
RECRUITING
El Paso
Investigative Site US032
RECRUITING
Frisco
Investigative Site US012
RECRUITING
Plano
Investigative Site US011
RECRUITING
San Antonio
Utah
Investigative Site US040
RECRUITING
Layton
Investigative Site US037
NOT_YET_RECRUITING
Murray
Investigative Site US039
COMPLETED
Ogden
Washington
Investigative Site US058
NOT_YET_RECRUITING
Seattle
Other Locations
Bulgaria
Investigative Site BG002
RECRUITING
Sofia
Investigative Site BG003
RECRUITING
Sofia
Canada
Investigative Site CA003
RECRUITING
Calgary
Investigative Site CA004
RECRUITING
Calgary
Investigative Site CA009
RECRUITING
Ottawa
Investigative Site CA002
RECRUITING
Peterborough
Investigative Site CA001
RECRUITING
Richmond Hill
Investigative Site CA008
NOT_YET_RECRUITING
Sherbrooke
Investigative Site CA005
RECRUITING
Toronto
Investigative Site CA007
RECRUITING
Toronto
Investigative Site CA006
RECRUITING
Waterloo
France
Investigative Site FR002
RECRUITING
Bordeaux
Investigative Site FR005
RECRUITING
Brest
Investigative Site FR004
RECRUITING
Nantes
Investigative Site FR003
RECRUITING
Nice
Investigative Site FR001
RECRUITING
Paris
Germany
Investigative Site DE005
NOT_YET_RECRUITING
Berlin
Investigative Site DE006
RECRUITING
Berlin
Investigative Site DE002
NOT_YET_RECRUITING
Bochum
Investigative Site DE004
NOT_YET_RECRUITING
Darmstadt
Investigative Site DE001
NOT_YET_RECRUITING
Dresden
Investigative Site DE003
RECRUITING
Erlangen
Investigative Site DE007
RECRUITING
Hamburg
Investigative Site DE008
RECRUITING
Lübeck
Italy
Investigative Site IT001
NOT_YET_RECRUITING
Catania
Investigative Site IT005
RECRUITING
Cona
Investigative Site IT009
NOT_YET_RECRUITING
Florence
Investigative Site IT003
NOT_YET_RECRUITING
Milan
Investigative Site IT007
RECRUITING
Naples
Investigative Site IT004
RECRUITING
Roma
Investigative Site IT006
RECRUITING
Roma
Investigative Site IT002
NOT_YET_RECRUITING
Rozzano
Investigative Site IT008
NOT_YET_RECRUITING
Torino
Poland
Investigative Site PL002
RECRUITING
Lodz
Investigative Site PL003
RECRUITING
Torun
Investigative Site PL001
RECRUITING
Warsaw
Investigative Site PL004
RECRUITING
Wroclaw
Spain
Investigative Site ES004
RECRUITING
Alicante
Investigative Site ES005
NOT_YET_RECRUITING
Badalona
Investigative Site ES003
RECRUITING
Barcelona
Investigative Site ES001
RECRUITING
Madrid
Investigative Site ES002
NOT_YET_RECRUITING
Madrid
United Kingdom
Investigative Site GB001
NOT_YET_RECRUITING
Cardiff
Investigative Site GB004
NOT_YET_RECRUITING
Harrogate
Investigative Site GB002
NOT_YET_RECRUITING
Ipswich
Investigative Site GB006
NOT_YET_RECRUITING
London
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: 2025-06-23
Estimated Completion Date: 2027-07-11
Participants
Target number of participants: 400
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.
Related Therapeutic Areas
Sponsors
Leads: Incyte Corporation

This content was sourced from clinicaltrials.gov