A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
| Заболевание | Multiple Sclerosis, Relapsing-Remitting |
|---|---|
| Фаза | Фаза 3 |
| Спонсор | Mapi Pharma Ltd. |
| Статус | Завершено |
| Участники | 1,016 участн. |
| Вмешательство | GA Depot |
| Дата начала | 19.09.2019 |
| Дата завершения | 13.06.2023 |
| Публикация результатов | 5.08.2026 |
Кратко
A multinational, multicenter, randomized, Phase III, double blind, parallel group, placebo controlled study in subjects with Relapsing Forms of Multiple Sclerosis (RMS) to assess the efficacy, safety and tolerability of GA Depot, a long acting IM injection of glatiramer acetate, administered once every four weeks
Annualized Relapse Rate (ARR)
| Early Start: GA Depot 40 mg | 0.182 ± 0.022 Relapses per participant per year |
|---|---|
| Delayed Start: Placebo | 0.260 ± 0.029 Relapses per participant per year |
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