A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
| 适应症 | Multiple Sclerosis, Relapsing-Remitting |
|---|---|
| 分期 | 3期 |
| 申办方 | Mapi Pharma Ltd. |
| 状态 | 已完成 |
| 受试者人数 | 1,016 人 |
| 干预（药物） | GA Depot |
| 开始日期 | 2019年9月19日 |
| 完成日期 | 2023年6月13日 |
| 结果公布日 | 2026年8月5日 |
摘要
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 |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
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