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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 US020
Phoenix, Arizona 85008

Investigative Site US033
Scottsdale, Arizona 85259

Investigative Site US054
Tempe, Arizona 85282

Investigative Site US002
Fayetteville, Arkansas 72703

Investigative Site US055
Brea, California 92821

Investigative Site US004
Laguna Niguel, California 92677

Investigative Site US007
Los Angeles, California 90033

Investigative Site US013
San Diego, California 92103

Investigative Site US060
San Diego, California 92120

Investigative Site US038
San Diego, California 92121

Investigative Site US059
Aurora, Colorado 80045

Investigative Site US045
Boynton Beach, Florida 33437

Investigative Site US028
Fort Myers, Florida 33912

Investigative Site US016
Miami, Florida 33142

Investigative Site US027
Sanford, Florida 32771

Investigative Site US057
Sweetwater, Florida 33172

Investigative Site US029
Tampa, Florida 33609

Investigative Site US053
Atlanta, Georgia 30331

Investigative Site US019
Marietta, Georgia 30060

Investigative Site US026
Chicago, Illinois 60657

Investigative Site US049
Clarksville, Indiana 47129

Investigative Site US052
West Lafayette, Indiana 47906

Investigative Site US001
Bowling Green, Kentucky 42104

Investigative Site US022
Louisville, Kentucky 40241

Investigative Site US050
Baton Rouge, Louisiana 70809

Investigative Site US046
Glenn Dale, Maryland 20769

Investigative Site US003
Boston, Massachusetts 02115

Investigative Site US030
Boston, Massachusetts 02215

Investigative Site US010
Quincy, Massachusetts 02169

Investigative Site US006
Minneapolis, Minnesota 55455

Investigative Site US021
New Brighton, Minnesota 55112

Investigative Site US036
Saint Joseph, Missouri 64506

Investigative Site US034
New City, New York 10956

Investigative Site US018
New York, New York 10003

Investigative Site US017
New York, New York 10023

Investigative Site US023
Rochester, New York 14623

Investigative Site US014
Chapel Hill, North Carolina 27516

Investigative Site US025
Fargo, North Dakota 58103

Investigative Site US015
Bexley, Ohio 43209

Investigative Site US044
Cincinnati, Ohio 45219

Investigative Site US008
Columbus, Ohio 43230

Investigative Site US031
Mason, Ohio 45040

Investigative Site US048
Oklahoma City, Oklahoma 73118

Investigative Site US056
Philadelphia, Pennsylvania 19107

Investigative Site US024
Charleston, South Carolina 29425

Investigative Site US041
Myrtle Beach, South Carolina 29788

Investigative Site US047
Nashville, Tennessee 37215

Investigative Site US062
Dallas, Texas 75390

Investigative Site US035
El Paso, Texas 79902

Investigative Site US032
Frisco, Texas 75033

Investigative Site US012
Plano, Texas 75025

Investigative Site US011
San Antonio, Texas 78213

Investigative Site US037
Murray, Utah 84107

Investigative Site US058
Seattle, Washington 98195

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.