An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
A legfontosabb adatok
- Hol
- Edmonton, London, Montreal és Québec (Kanada)Mind a 4 helyszín megnézése
- Fázis
- 3. fázis
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 100 év között vagy?
Forrás: NCT07665437: ki vehet részt
Helyszínek itt: Kanada
- Edmonton, AlbertaHospital not named in the registryContact: Novartis PharmaceuticalsRésztvevőt keres
- London, OntarioHospital not named in the registryContact: Novartis PharmaceuticalsRésztvevőt keres
- Montreal, QuebecHospital not named in the registryContact: Novartis PharmaceuticalsRésztvevőt keres
- Québec, QuebecHospital not named in the registryContact: Novartis PharmaceuticalsRésztvevőt 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
- Novartis Pharmaceuticals
- Azonosító
- NCT07665437EU 2025-523259-72-00
- A regiszteradat frissítve
- 2026. november 9.
- Eredeti leírás
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of remibrutinib (LOU064) in adult participants with moderate to severe hidradenitis suppurativa (HS) who have completed either of the preceding Phase 3 studies, CLOU064J12301 or CLOU064J12302.A teljes eredeti leírásKevesebb
A Double-blind, Double-dummy, Parallel Group, Multicenter Phase 3 Extension Study Evaluating the Long-term Safety and Efficacy of 2 Doses of Remibrutinib in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of remibrutinib (LOU064) in adult participants with moderate to severe hidradenitis suppurativa (HS) who have completed either of the preceding Phase 3 studies, CLOU064J12301 or CLOU064J12302.
Bevonási feltételek: Signed informed consent must be obtained before any assessment is performed; Participant has completed the full study treatment period according to the protocol (68 weeks) in the core studies (CLOU064J12301 or CLOU064J12302); Participant does not meet any treatment discontinuation criteria of the core study at Week 68.
Kizáró feltételek: Current severe progressive or uncontrolled disease, which in the judgment of the Investigator renders the participant unsuitable for the study; Other protocol-defined inclusion/exclusion criteria may apply; Ongoing or planned use of prohibited HS or non-HS treatments; Participants not expected to benefit from participation in the extension study or participants expected to be exposed to an undue safety risk if participating in the extension study, as assessed by the Investigator.