A Phase 2, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Povorcitinib in Adolescents With Moderate to Severe Hidradenitis Suppurativa
Incyte Corporation
Summary
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
- Age range
- 12–17 years
- Sex
- All
- 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 antibioti…
Interventions
- DrugPovorcitinib
Oral; Tablet
Locations (27)
- University of Alabama At BirminghamBirmingham, Alabama
- Medical Dermatology Specialists PhoenixPhoenix, Arizona
- Saguaro DermatologyPhoenix, Arizona
- Uconn HealthFarmington, Connecticut
- University of Miami Miller School of MedicineMiami, Florida
- Skin Research of South Florida, LlcMiami, Florida