Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Mod
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(s) | Hidradenitis Suppurativa (HS) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 ab |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Lead sponsor | Incyte Corporation |
| Locations | Birmingham, Alabama, United States; Phoenix, Arizona, United States; Phoenix, Arizona, United States; Farmington, Connecticut, United States; Miami, Florida, United States; Miami, Florida, United States (+23 more sites) |
| Start date | 2026-02-02 |
| NCT ID | NCT07213973 |
| Official listing | https://clinicaltrials.gov/study/NCT07213973 |