Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
A legfontosabb adatok
- Hol
- Mississauga, Richmond Hill, St. John's és Toronto (Kanada)Mind a 4 helyszín megnézése
- Fázis
- 2. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 12 és 17 év között vagy?
Forrás: NCT07213973: ki vehet részt
Helyszínek itt: Kanada
- Dermcare ClinicMississauga, KanadaRésztvevőt keres
- York Dermatology CenterRichmond Hill, KanadaRésztvevőt keres
- Skincare Studio Dermatology CentreSt. John's, KanadaRésztvevőt keres
- The Hospital for Sick ChildrenToronto, KanadaRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Incyte Corporation
- Azonosító
- NCT07213973
- A regiszteradat frissítve
- 2026. október 9.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
A Phase 2, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Povorcitinib in Adolescents With Moderate to Severe Hidradenitis Suppurativa
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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; Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit; Women who are pregnant (or who are considering pregnancy) or breastfeeding; Further exclusion criteria apply.