An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Remibrutinib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Remibrutinib.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 648
- 试验地点
- 41
- 主要终点
- Number of participants with the occurrence of AEs or SAEs
研究概览
简要总结
Multi-center, open-label roll-over post-trial access protocol to provide remibrutinib treatment and collect long-term safety for up to three years for participants who are currently receiving remibrutinib treatment in a Novartis-sponsored study, who are benefiting from treatment with remibrutinib, and are unable to access remibrutinib treatment outside of a clinical study.
详细描述
There will be no screening period for this study. After completion of the appropriate consent process, eligible participants can start treatment with remibrutinib as soon as they enter the study. All participants must visit the study site for their enrollment visit to confirm eligibility and commence study participation. Participants will return to the study center at least every 16 weeks for resupply of study medication but may return earlier if needed.
Participants will receive remibrutinib at the dose and regimen they last received in the parent study.
Participants will continue to receive remibrutinib for up to 3 years or until one of the following occurs: no treatment benefit, participant wishes to discontinue trial participation or withdraws consent, protocol non-compliance, pregnancy, the investigator feels it is no longer in the participant's best interest to continue therapy, or the participant receives access to treatment with remibrutinib outside of a clinical study, whichever occurs first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •- Participant has completed treatment per protocol in a Novartis study of remibrutinib (unless otherwise specified in a parent study protocol) in a dermatological or allergology indication.
- •Participants, who derive benefit from the treatment with remibrutinib but have not completed the treatment in certain parent studies due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (e.g., technical / administrative reasons).
- •Participant is deriving benefit from remibrutinib, investigator believes he/she would continue to derive benefit from remibrutinib and the benefit outweighs the risk, based on the investigator's judgement.
- •Participant is unable to obtain access to the marketed remibrutinib formulation per local post study drug supply program, prescription and/or reimbursement guidelines.
排除标准
- •Participants meeting any of the following criteria are not eligible for inclusion in this study.
- •Participant has prematurely discontinued study treatment in the parent study.
- •Use of prohibited medications
研究组 & 干预措施
Remibrutinib dose level 1
Remibrutinib film coated tablets in the respective dose strength of the parent study
干预措施: Remibrutinib (Drug)
Remibrutinib dose level 2
Remibrutinib film coated tablets in the respective dose strength of the parent study
干预措施: Remibrutinib (Drug)
结局指标
主要结局
Number of participants with the occurrence of AEs or SAEs
时间窗: throughout the study, approximately 7 years
Number of participants with the occurrence of AEs or SAEs
次要结局
未报告次要终点