A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
3期
招募中
NCT04951622
| 适应症 | Myasthenia Gravis |
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| 分期 | 3期 |
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| 申办方 | Janssen Research & Development, LLC |
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| 状态 | 招募中 |
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| 受试者人数 | 199 人 |
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| 干预（药物） | Nipocalimab, Nipocalimab SC-LIV |
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| 开始日期 | 2021年7月15日 |
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| 完成日期 | 2023年11月17日 |
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| 结果公布日 | 2025年7月23日 |
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摘要
The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). The purpose of the subcutaneous substudy is to evaluate how well it works in the body (pharmacodynamic \[PD\]) when given as an injection under the skin (subcutaneous) compared to when given through a vein (intravenous) in participants with gMG.
Double-blind (DB) Phase: Average Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24
Baseline, Weeks 22, 23, and 24 · Score on a scale
| Double Blind (DB) Phase: Placebo | -3.25 ± 0.335 Score on a scale |
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| DB Phase: Nipocalimab | -4.70 ± 0.329 Score on a scale |
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| p-value | =0.002 |
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| Difference of LS Means | -1.45 (95% CI -2.38–-0.52) |
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Sub Study: Percent Change in Anti-AChR Autoantibody Titer From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57)
From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57)
Sub Study: Percent Change in Total IgG Levels From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57)
From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57)
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