Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (TRuE-HS1)

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

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 5308655, Arizona 5551752 85008

Investigative Site US033
Scottsdale 5313457, Arizona 5551752 85259

Investigative Site US054
Tempe 5317058, Arizona 5551752 85282

Investigative Site US002
Fayetteville 4110486, Arkansas 4099753 72703

Investigative Site US055
Brea 5330582, California 5332921 92821

Investigative Site US004
Laguna Niguel 5364329, California 5332921 92677

Investigative Site US007
Los Angeles 5368361, California 5332921 90033

Investigative Site US013
San Diego 5391811, California 5332921 92103

Investigative Site US060
San Diego 5391811, California 5332921 92120

Investigative Site US038
San Diego 5391811, California 5332921 92121

Investigative Site US045
Boynton Beach 4148677, Florida 4155751 33437

Investigative Site US028
Fort Myers 4155995, Florida 4155751 33912

Investigative Site US016
Miami 4164138, Florida 4155751 33142

Investigative Site US027
Sanford 4172086, Florida 4155751 32771

Investigative Site US057
Sweetwater 4174600, Florida 4155751 33172

Investigative Site US029
Tampa 4174757, Florida 4155751 33609

Investigative Site US019
Marietta 4207783, Georgia 4197000 30060

Investigative Site US026
Chicago 4887398, Illinois 4896861 60657

Investigative Site US049
Clarksville 4255836, Indiana 4921868 47129

Investigative Site US052
West Lafayette 4928096, Indiana 4921868 47906

Investigative Site US001
Bowling Green 4285268, Kentucky 6254925 42104

Investigative Site US022
Louisville 4299276, Kentucky 6254925 40241

Investigative Site US050
Baton Rouge 4315588, Louisiana 4331987 70809

Investigative Site US046
Glenn Dale 4356289, Maryland 4361885 20769

Investigative Site US003
Boston 4930956, Massachusetts 6254926 02115

Investigative Site US010
Quincy 4948247, Massachusetts 6254926 02169

Investigative Site US006
Minneapolis 5037649, Minnesota 5037779 55455

Investigative Site US021
New Brighton 5039080, Minnesota 5037779 55112

Investigative Site US036
Saint Joseph 4407010, Missouri 4398678 64506

Investigative Site US034
New City 5128481, New York 5128638 10956

Investigative Site US018
New York 5128581, New York 5128638 10003

Investigative Site US017
New York 5128581, New York 5128638 10023

Investigative Site US023
Rochester 5134086, New York 5128638 14623

Investigative Site US014
Chapel Hill 4460162, North Carolina 4482348 27516

Investigative Site US025
Fargo 5059163, North Dakota 5690763 58103

Investigative Site US015
Bexley 4506487, Ohio 5165418 43209

Investigative Site US044
Cincinnati 4508722, Ohio 5165418 45219

Investigative Site US008
Columbus 4509177, Ohio 5165418 43230

Investigative Site US031
Mason 4517698, Ohio 5165418 45040

Investigative Site US048
Oklahoma City 4544349, Oklahoma 4544379 73118

Investigative Site US056
Philadelphia 4560349, Pennsylvania 6254927 19107

Investigative Site US024
Charleston 4574324, South Carolina 4597040 29425

Investigative Site US041
Myrtle Beach 4588718, South Carolina 4597040 29788

Investigative Site US047
Nashville 4644585, Tennessee 4662168 37215

Investigative Site US062
Dallas 4684888, Texas 4736286 75390

Investigative Site US035
El Paso 5520993, Texas 4736286 79902

Investigative Site US032
Frisco 4692559, Texas 4736286 75033

Investigative Site US012
Plano 4719457, Texas 4736286 75025

Investigative Site US011
San Antonio 4726206, Texas 4736286 78213

Investigative Site US040
Layton 5777107, Utah 5549030 84041

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

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