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Purpose

The purpose of this study is to evaluate the maximal use of ruxolitinib cream in adult and adolescent participants with hidradenitis suppurativa.

Condition

Eligibility

Eligible Ages
Between 12 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of HS for at least 6 months before screening visit. - Diagnosis of HS (Hurley Stage I, II, III) with a total abscess and inflammatory nodule count of at least 4 and affecting at least 3 distinct anatomical areas at screening and Day 1 visits. - Total estimated treatment BSA > 20% at screening and baseline. - Agreement to not use topical or systemic antibiotics for treatment of HS during the Maximal Use Treatment Period. - Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol. - Further inclusion criteria apply.

Exclusion Criteria

  • Current or history of skin condition(s) other than HS that might confound the evaluation of HS; clinically uncontrolled cardiovascular disease; thrombosis; certain cancers; certain infections; severe anemia, thrombocytopenia, or neutropenia; other medical conditions at the discretion of the investigator. - Laboratory values outside of the protocol-defined ranges. - Further exclusion criteria apply.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

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.

Recruiting Locations

First Oc Dermatology
Fountain Valley 5350207, California 5332921 92708

Amicis Research Center Valencia
Northridge 5377985, California 5332921 91324

Clinical Trials Research Institute
Thousand Oaks 5402405, California 5332921 91320

International Clinical Research Tennessee Llc
Sanford 4172086, Florida 4155751 32771

Lenus Research Medical Group, Llc
Sweetwater 4174600, Florida 4155751 33172

Trueblue Clinical Research
Tampa 4174757, Florida 4155751 33609

Lane Dermatology and Dermatologic Surgery
Columbus 4188985, Georgia 4197000 31904

Equity Medical, Llc
Bowling Green 4285268, Kentucky 6254925 42104

Delricht Research
Baton Rouge 4315588, Louisiana 4331987 70809

Revival Research Institute, Llc Troy
Troy 5012639, Michigan 5001836 48084

Red River Research Partners
Bolivar 4377835, Missouri 4398678 65613

Equity Medical, Llc
New York 5128581, New York 5128638 10019

Red River Research Partners
Fargo 5059163, North Dakota 5690763 58103

Centricity Research Columbus
Columbus 4509177, Ohio 5165418 43213

Unity Clinical Research
Oklahoma City 4544349, Oklahoma 4544379 73118

Paddington Testing Co Inc
Philadelphia 4560349, Pennsylvania 6254927 19103

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.