A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Фаза 3
Набор
NCT04951622
| Заболевание | Myasthenia Gravis |
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| Фаза | Фаза 3 |
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| Спонсор | Janssen Research & Development, LLC |
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| Статус | Набор |
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| Участники | 199 участн. |
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| Вмешательство | Nipocalimab, Nipocalimab SC-LIV |
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| Дата начала | 15.07.2021 |
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| Дата завершения | 17.11.2023 |
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| Публикация результатов | 23.07.2025 |
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Кратко
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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