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.
Eligibility
Sex
ALL
Min age
12 Years
Max age
17 Years
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.
Primary outcome measure(s)
Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) — Baseline through Week 54 TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug.
Apparent clearance — Up to Week 24
Apparent volume of distribution — Up to Week 24
Apparent oral absorption rate constant — Up to Week 24
Absorption lag time — Up to Week 24
Maximum plasma drug concentration at steady state — Up to Week 24
Average plasma drug concentration at steady state — Up to Week 24
Plasma concentration at steady state for the dosing interval — Up to Week 24
Time to maximum plasma concentration at steady state — Up to Week 24
Terminal half-life — Up to Week 24
Trial sites (30)
Facility
City
Region
Status
University of Alabama At Birmingham
Birmingham
Alabama
Recruiting
Medical Dermatology Specialists Phoenix
Phoenix
Arizona
Recruiting
Saguaro Dermatology
Phoenix
Arizona
Recruiting
Uconn Health
Farmington
Connecticut
Recruiting
University of Miami Miller School of Medicine
Miami
Florida
Recruiting
Skin Research of South Florida, Llc
Miami
Florida
Recruiting
Trueblue Clinical Research
Tampa
Florida
Recruiting
Advanced Medical Research Pc
Sandy Springs
Georgia
Recruiting
Endeavor Health Medical Group
Skokie
Illinois
Recruiting
Dermatology Skin Cancer Center Leawood
Leawood
Kansas
Recruiting
Equity Medical
Bowling Green
Kentucky
Recruiting
Johns Hopkins Univ Schl of Medicine
Baltimore
Maryland
Recruiting
Skin Oasis Dermatology
Gambrills
Maryland
Not Yet Recruiting
Boston Childrens Hospital
Boston
Massachusetts
Recruiting
Oakland Hills Dermatology Pc
Auburn Hills
Michigan
Recruiting
Wayne State University Physician Group Dermatology
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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