Study to Evaluate the Maximal Use of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa
Purpose
The purpose of this study is to evaluate the maximal use of ruxolitinib cream in adult and adolescent participants with hidradenitis suppurativa.
Condition
- Hidradenitis Suppurativa
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ruxolitinib 1.5 % Cream |
Participants received ruxolitinib 1.5% cream, applied topically to the affected area as defined in the protocol. |
|
Recruiting Locations
Saguaro Dermatology
Phoenix, Arizona 85008
Phoenix, Arizona 85008
First Oc Dermatology
Fountain Valley, California 92708
Fountain Valley, California 92708
Amicis Research Center Valencia
Northridge, California 91324
Northridge, California 91324
Clinical Trials Research Institute
Thousand Oaks, California 91320
Thousand Oaks, California 91320
Clarity Dermatology
Castle Rock, Colorado 80109
Castle Rock, Colorado 80109
International Clinical Research Tennessee Llc
Sanford, Florida 32771
Sanford, Florida 32771
Lenus Research Medical Group, Llc
Sweetwater, Florida 33172
Sweetwater, Florida 33172
Trueblue Clinical Research
Tampa, Florida 33609
Tampa, Florida 33609
Lane Dermatology and Dermatologic Surgery
Columbus, Georgia 31904
Columbus, Georgia 31904
Options Research Group, Llc
West Lafayette, Indiana 47906
West Lafayette, Indiana 47906
Equity Medical, Llc
Bowling Green, Kentucky 42104
Bowling Green, Kentucky 42104
Delricht Research
Baton Rouge, Louisiana 70809
Baton Rouge, Louisiana 70809
Revival Research Institute, Llc Troy
Troy, Michigan 48084
Troy, Michigan 48084
Red River Research Partners
Bolivar, Missouri 65613
Bolivar, Missouri 65613
Dr Bobby Buka, Md Greenwich Village
New York, New York 10012-1354
New York, New York 10012-1354
Equity Medical, Llc
New York, New York 10019
New York, New York 10019
Red River Research Partners
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Centricity Research Columbus
Columbus, Ohio 43213
Columbus, Ohio 43213
Unity Clinical Research
Oklahoma City, Oklahoma 73118
Oklahoma City, Oklahoma 73118
Paddington Testing Co Inc
Philadelphia, Pennsylvania 19103
Philadelphia, Pennsylvania 19103
More Details
- Status
- Recruiting
- Sponsor
- Incyte Corporation