A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS

Phase 3 Completed 1016 enrolled Mapi Pharma Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start: 2019-09-19
Primary completion: 2023-06-13
Completion: 2023-06-13

Outcome

Met primary endpoint

paper Adjusted ARR was lower in patients treated with GA Depot compared to placebo PMID 41705515 ↗

paper 30.1% relative risk reduction, p = 0.0066). PMID 41705515 ↗

release “The study met its primary endpoint showing that GA Depot 40 mg statistically significantly reduced the annualized relapse rate by 30.1 percent compared to placebo” viatris.com ↗

release “Top-line efficacy results showed that GA Depot 40 mg meet the primary endpoint versus placebo in significantly reducing the ARR.” mapi-pharma.com ↗

Publications

Miller A, Cohen JA, Karni A, Popper L, Bleich Kimelman N, Rubnov S, Danon U, Marom E, Boyko A, Zivadinov R, Berger JR, Bar-Or A, Kolb H. GA Depot, a long-acting glatiramer acetate, vs placebo in patients with relapsing multiple sclerosis: A randomized phase 3 clinical trial. Mult Scler. 2026 Feb;32(2):202-213. doi: 10.1177/13524585251405101. Epub 2026 Feb 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glatiramer Acetate	Small molecule	40 mg	Intramuscular