NCT04121221

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

A Phase III Study in Subjects With Relapsing Forms of Multiple Sclerosis (RMS) to Asses Efficacy, Safety and Tolerability of GA Depot, a Long Acting IM Injection of Glatiramer Acetate, Once Monthly Compared to Placebo

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,016 (actual)
• Sponsor: Mapi Pharma Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Detailed description

A total of 1000 subjects are planned to be randomized into this study to receive treatment with GA Depot or with matching placebo. During the placebo controlled period (PC period, the first 52 weeks of the study immediately after randomization) subjects will receive either 40mg of GA Depot or matching placebo, IM, once every 4 weeks, for a total of 13 times. Subjects who complete the PC period of the study will be offered to continue into the open label period (OL period) for an additional 52 weeks, in which all subjects will receive 40mg of GA Depot IM once every 4 weeks.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	GA Depot	Long acting intramuscular injection of glatiramer acetate, once every 4 weeks
OTHER	Placebo	IM injection once every 4 weeks

Timeline

• Start date: 2019-09-19
• Primary completion: 2023-06-13
• Completion: 2023-06-13
• First posted: 2019-10-09
• Last updated: 2023-12-01

Locations

112 sites across 10 countries: United States, Belarus, Bosnia and Herzegovina, Bulgaria, Estonia, Georgia, Israel, Moldova, Russia, Ukraine

Regulatory

• FDA-regulated drug study