NCT07217587招募中3 期
Efficacy and Safety of Nipocalimab vs Efgartigimod for Patients With Generalized Myasthenia Gravis in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 115
- 试验地点
- 18
- 主要终点
- Arms 1 and 2: Averaged Mean Percent Change from Baseline in Total Immunoglobulin G (IgG) Levels Over Weeks 8, 10 and 12
研究概览
简要总结
The purpose of this study is to assess how well nipocalimab works when compared to efgartigimod in participants with generalized myasthenia gravis (a condition in which body's immune system mistakenly attacks and damages the connection between nerves and muscles causing muscle weakness).
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
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For all arms:
- •Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG) performed at screening
- •Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized MG (gMG) as defined by the Myasthenia gravis foundation of America (MGFA) clinical classification class II a/b, III a/b, or IV a/b at screening and positive for acetylcholine receptor (AChR) antibodies
- •Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of greater than or equal to (>=) 5 with less than (<) 50% of symptoms coming from ocular MG-ADL sub-scores at study screening and baseline (Day 1) visits
- •Criteria specific to Arms 1 and 2 only:
- •- Has suboptimal response to current stable therapy for gMG according to the investigator or has discontinued corticosteroids and/or immunosuppressants/immunomodulators including eculizumab or other novel approved immune agents at least 4 weeks prior to baseline due to intolerance or lack of efficacy
- •Criteria specific to Arm 3:
- •- Treatment with efgartigimod IV or subcutaneous (SC) for >=1 cycle, and the final cycle is consistent with product information
排除标准
- •Any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
- •Had a thymectomy within 1 year prior to baseline, or thymectomy is planned during the study
- •Currently has a malignancy or has a history of malignancy within 3 years before baseline
- •Criteria specific to Arms 1 and 2 only:
- •- Has received treatment for MG with an FcRn-targeting therapy
- •Criteria specific to Arm 3 only:
- •- Is currently taking IgG monoclonal antibody therapeutics, or Fc-conjugated therapeutic agents, including factor or enzyme replacement, with the exception of efgartigimod
研究组 & 干预措施
Arm 3: Treatment Switch (Nipocalimab)
Experimental
Participants previously treated with efgartigimod, who are directly enrolled in this arm, and eligible participants switching from Arm 2 will receive nipocalimab IV at a loading dose on Switch Day 1 followed by maintenance dosing q2w until Switch Week 12.
干预措施: Nipocalimab (Drug)
Arm 1: Nipocalimab
Experimental
Participants will receive nipocalimab intravenously (IV), at a loading dose on Day 1 followed by maintenance dosing once every 2 weeks (q2w) until Week 12.
干预措施: Nipocalimab (Drug)
Arm 2: Efgartigimod
Active Comparator
Participants will receive efgartigimod IV, once a week for 4 weeks starting from Day 1. Eligible participants will be given the option to switch to Arm 3 between Week 4 and Week 12.
干预措施: Efgartigimod (Drug)
结局指标
主要结局
Arms 1 and 2: Averaged Mean Percent Change from Baseline in Total Immunoglobulin G (IgG) Levels Over Weeks 8, 10 and 12
时间窗: Baseline, Weeks 8, 10 and 12
Average mean percent change from baseline in total IgG levels over Weeks 8 , 10 and 12 will be reported.
次要结局
- Arms 1 and 2: Averaged Mean Change from Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score Over Weeks 8, 10 and 12(Baseline, Weeks 8, 10 and 12)
- Arms 1 and 2: Mean Percent Change from Baseline in Total IgG Levels at Week 8(Baseline and Week 8)
- Arms 1 and 2: Mean Change from Baseline in MG-ADL Total Score at Week 8(Baseline and Week 8)
- Arms 1 and 2: Averaged Mean Change from Baseline in Quantitative Myasthenia Gravis (QMG) Total Score Over Weeks 8 and 12(Baseline, Weeks 8 and 12)
- Arms 1 and 2: Mean Change from Baseline in QMG Total Score at Week 8(Baseline and Week 8)
- Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for At Least 6 Weeks During Randomized Treatment Phase(Baseline up to Week 12)
- Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for At Least 8 Weeks During Randomized Treatment Phase(Baseline up to Week 12)
- Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for 50% of Postbaseline Observations(Baseline, Week 2 up to Week 12)
- Arms 1 and 2: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for 75% of Postbaseline Observations(Baseline, Week 2 up to Week 12)
- Arms 1 and 2: Percentage of Participants with MG-ADL Total Score of 0 or 1 at Week 12(Week 12)
- Arm 3: Mean Percent Change in Total IgG from Switch Day 1 to Switch Week 12(Switch Day 1 to Switch Week 12)
- Arm 3: Mean Change in MG-ADL Total Score from Switch Day 1 to Switch Week 12(Switch Day 1 to Switch Week 12)
- Arm 3: Percentage of Participants with >= 2-Point Improvement in MG-ADL Total Score at Switch Week 12(At Switch Week 12)
- Arm 3: Percentage of Participants Maintaining >= 2-Point Improvement in MG-ADL Total Score for At Least 6 Weeks During Treatment Phase(Switch Day 1 up to Switch Week 12)
- Arm 3: Percentage of Participants with MG-ADL Total Score of 0 or 1 at Switch Week 12(At Switch Week 12)
- Arms 1 and 2: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)(Up to Week 20)
- Arm 3: Number of Participants with AEs, SAEs and AESIs(Up to Switch Week 20)
- Arms 1 and 2: Mean Percent Change from Baseline in Total IgG Between Arm 1 at EoT and Arm 2 at EoC Based on Clinical Evaluation(Baseline, EoT (for Arm 1) and EoC (Arm 2) up to Week 12)
- Arms 1 and 2: Mean Percent Change from Baseline in MG-ADL Total Score Between Arm 1 at EoT and Arm 2 at EoC Based on Clinical Evaluation(Baseline, EoT (for Arm 1) and EoC (Arm 2) up to Week 12)
- Arms 1 and 2: Mean Percent Change from Baseline in QMG Total Score Between Arm 1 at EoT and Arm 2 at EoC Based on Clinical Evaluation(Baseline, EoT (for Arm 1) and EoC (Arm 2) up to Week 12)
研究者
研究点 (18)
Loading locations...
相似试验
招募中
2 期
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)NCT05327114Janssen Research & Development, LLC201
招募中
3 期
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia GravisMyasthenia GravisNCT04951622Janssen Research & Development, LLC199
已完成
2 期
A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid ArthritisArthritis, RheumatoidNCT04991753Janssen Research & Development, LLC53
进行中（未招募）
2 期
A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory MyopathiesMyositisNCT05379634Janssen Research & Development, LLC36
已完成
2 期
A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid ArthritisArthritis, RheumatoidNCT06028438Janssen Research & Development, LLC103