Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
Purpose
The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of povorcitinib in adolescent participants with moderate to severe hidradenitis suppurativa over a 54-week open-label treatment period.
Condition
- Hidradenitis Suppurativa (HS)
Eligibility
- Eligible Ages
- Between 12 Years and 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Aged ≥ 12 to < 18 years at the time of informed consent/assent signing. - Body weight ≥ 30 kg at both screening and baseline visits. - Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit. - Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits. - HS lesions corresponding to refined Hurley Stage IB, IC, IIB, IIC, or III at both the screening and baseline visits. - Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS). - Agreement to use contraception. - Willing and able to comply with the study protocol and procedures. - Further inclusion criteria apply.
Exclusion Criteria
- Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit. - Women who are pregnant (or who are considering pregnancy) or breastfeeding. - Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, 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 ranges. - Further exclusion criteria apply.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Povorcitinib Dose A |
Participants will receive povorcitinib dose A for 54 weeks. |
|
|
Experimental Povorcitinib Dose B |
Participants will receive povorcitinib dose B for 54 weeks. |
|
Recruiting Locations
Medical Dermatology Specialists Phoenix
Phoenix, Arizona 85006
Phoenix, Arizona 85006
Saguaro Dermatology
Phoenix, Arizona 85008
Phoenix, Arizona 85008
University of Miami Miller School of Medicine
Miami, Florida 33136
Miami, Florida 33136
Skin Research of South Florida, Llc
Miami, Florida 33173
Miami, Florida 33173
Trueblue Clinical Research
Tampa, Florida 33609
Tampa, Florida 33609
Advanced Medical Research Pc
Sandy Springs, Georgia 30328
Sandy Springs, Georgia 30328
Endeavor Health Medical Group
Skokie, Illinois 60077
Skokie, Illinois 60077
Dermatology Skin Cancer Center Leawood
Leawood, Kansas 66211
Leawood, Kansas 66211
Equity Medical
Bowling Green, Kentucky 42104
Bowling Green, Kentucky 42104
Johns Hopkins Oncology Center
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Oakland Hills Dermatology Pc
Auburn Hills, Michigan 48326
Auburn Hills, Michigan 48326
Wayne State University Physician Group Dermatology
Detroit, Michigan 48201
Detroit, Michigan 48201
Revival Research Institute, Llc Troy
Troy, Michigan 48084
Troy, Michigan 48084
Washington University
St Louis, Missouri 63110
St Louis, Missouri 63110
Boeson Research Missoula 2825 Fort Missoula Rd
Missoula, Montana 59804
Missoula, Montana 59804
University of New Mexico Hospital
Albuquerque, New Mexico 87102
Albuquerque, New Mexico 87102
Bellaire Dermatology Associates Bda
Bellaire, Texas 77401
Bellaire, Texas 77401
Texas Dermatology Research Center
Dallas, Texas 75246
Dallas, Texas 75246
Jordan Valley Dermatology Center
South Jordan, Utah 84095
South Jordan, Utah 84095
More Details
- Status
- Recruiting
- Sponsor
- Incyte Corporation