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Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa

NCT07213973

RecruitingPhase 2

Sponsor: Incyte Corporation

Conditions: Hidradenitis Suppurativa (HS)

Interventions: Povorcitinib

Countries: United States, Canada

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 overview

Sex: ALL

Age: 12 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (30)

Birmingham, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Farmington, Connecticut, United States
Miami, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Sandy Springs, Georgia, United States
Skokie, Illinois, United States
Leawood, Kansas, United States
Bowling Green, Kentucky, United States
Baltimore, Maryland, United States
Gambrills, Maryland, United States
Boston, Massachusetts, United States
Auburn Hills, Michigan, United States
Detroit, Michigan, United States
Troy, Michigan, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Albuquerque, New Mexico, United States
Danville, Pennsylvania, United States
Bellaire, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
South Jordan, Utah, United States
Mississauga, Ontario, Canada
Richmond Hill, Ontario, Canada
Toronto, Ontario, Canada
St. John's, Canada