A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
第3相
募集中
NCT04951622
| 対象疾患 | Myasthenia Gravis |
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| 相 | 第3相 |
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| スポンサー | Janssen Research & Development, LLC |
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| ステータス | 募集中 |
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| 参加者数 | 199 名 |
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| 介入（薬剤） | Nipocalimab, Nipocalimab SC-LIV |
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| 開始日 | 2021年7月15日 |
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| 完了日 | 2023年11月17日 |
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| 結果公開日 | 2025年7月23日 |
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概要
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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