An Open-label, Multi-center Protocol for Patients Who Have Completed a Previous Novartis Sponsored Secukinumab Study and Are Judged by the Investigator to Benefit From Continued Secukinumab Treatment
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 202
- 主要终点
- To evaluate long term safety as assessed by occurrence of AEs/SAEs
研究概览
简要总结
The purpose of this study is to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent must be obtained for adult participants before any assessment is performed. Written informed assent and parental permission (age as per local law) must be obtained for pediatric participants before any assessment is performed. If participants reach age of consent (age as per local law) during the study, they will need to also sign the corresponding study informed consent(s).
- •Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
- •Participant has completed treatment per protocol in a Novartis study of secukinumab (unless otherwise specified in a parent study protocol). Participants, who derive benefit from the treatment with secukinumab 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 (technical / administrative reasons).
- •Participant is deriving benefit from secukinumab, investigator believes he/she would continue to derive benefit from secukinumab and the benefit outweighs the risk, based on the investigator's judgement.
- •Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines.
排除标准
- •Participant has prematurely discontinued study treatment in the parent protocol.
- •Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 weeks).
研究组 & 干预措施
Secukinumab s.c.
Participants will be started on 75 mg, 150 mg or 300 mg s.c. Q4W depending on what dose the participant was receiving in the parent trial (for trials with i.v. formulation the starting dose will be 300 mg s.c.). The study medication dose may be modified basedu pon clinical need, the judgement of the investigator and health authority guidelines (if applicable). For pediatric participants, the dose should not be increased beyond the maximum dose evaluated in the respective weight category in the parent protocol.
干预措施: Secukinumab s.c. injection (Biological)
结局指标
主要结局
To evaluate long term safety as assessed by occurrence of AEs/SAEs
时间窗: up to 2 years
Serious adverse events (SAEs), adverse events (AEs), and injection site reactions
次要结局
未报告次要终点