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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 710
- 试验地点
- 20
研究概览
简要总结
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.
详细描述
This is a global Phase 3, multicentre, double-blind, double-dummy, parallel-group extension study. It fulfils the Novartis commitment to provide post-trial access.
The study includes a double-blind and an open-label treatment phase:
Double-blind, double-dummy treatment continues from Week 68 (end of core study) until final database lock (DBL) of both core studies or until up titration. Participants remain on the same blinded regimen they were on during Treatment Period 2 of the preceding Phase 3 studies.
After final DBL of both core studies, treatment transitions to open-label.
Participants will continue treatment until commercial availability and reimbursement in their country, another access mechanism is available, or 4 years of extension treatment is completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •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.
研究组 & 干预措施
Remibrutinib Dose A
Participants randomized during the core study to receive remibrutinib Dose A
干预措施: Remibrutinib (Drug)
Remibrutinib Dose B
Participants randomized during the core study to receive remibrutinib Dose B
干预措施: Remibrutinib (Drug)