A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- argenx
- 入组人数
- 70
- 试验地点
- 37
- 主要终点
- To determine the safety and tolerability of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes
研究概览
简要总结
ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.
详细描述
This is a platform study and is governed by a single master protocol that enables multiple regimens to be evaluated in separate intervention-specific appendixes (ISAs).
The key design structure of the platform study comprises: common master protocol screening period, ISA-specific screening period, ISA treatment period of variable duration and design and ISA safety follow-up/follow-up period of variable duration.
Details on each study period will be specified in the ISAs. Following ISAs are included in this platform study:
- NCT07284420 - ADAPT Forward 1 - a study to evaluate empasiprubart IV as add-on therapy to efgartigimod IV in participants with AChR-Ab seropositive generalized myasthenia gravis with a partial clinical response to efgartigimod (https://www.clinicaltrials.gov/study/NCT07284420)
- NCT07673627 - Adapt Forward 2 - a Study to Evaluate the Safety, Tolerability and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis (https://clinicaltrials.gov/study/NCT07673627)
More information can be found here: https://clinicaltrials.argenx.com/adaptforward
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 18 years of age and the local legal age of consent for clinical studies
- •Has been diagnosed with MG with consistent clinical features per the investigator's clinical judgment
- •If receiving MG therapy, including nonsteroidal immunosuppressive drugs (NSIDs), corticosteroids, or acetylcholinesterase (AChE) inhibitors either in combination or alone, the participant should receive a stable dosage before master protocol screening
排除标准
- •Known autoimmune disease or any medical condition other than the indication under study that would interfere with an accurate assessment of clinical symptoms of MG or puts the participant at undue risk
- •Is MGFA (Myasthenia Gravis Foundation of America) Class V
研究组 & 干预措施
ISA2 participants
Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
干预措施: Empasiprubart IV (Biological)
ISA2 participants
Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
干预措施: Placebo IV (Other)
ISA2 participants
Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
干预措施: Efgartigimod PH20 SC PFS (Biological)
ISA1 participants
Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
干预措施: Empasiprubart IV (Biological)
ISA1 participants
Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
干预措施: Efgartigimod IV (Biological)
结局指标
主要结局
To determine the safety and tolerability of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes
时间窗: Up to approximately 7 years (the duration of each ISA will vary and be specified on the ISA records)
次要结局
- To evaluate the efficacy of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes(Up to approximately 7 years (the duration of each ISA will vary and be specified on the ISA records))