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

  • STATUS
    Recruiting
  • End date
    Apr 18, 2023
  • participants needed
    960
  • sponsor
    Mapi Pharma Ltd.
Updated on 18 March 2021
ACTH
glatiramer

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

Description

A total of 960 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.

Details
Condition relapsing-remitting multiple sclerosis
Treatment Placebo, GA Depot
Clinical Study IdentifierNCT04121221
SponsorMapi Pharma Ltd.
Last Modified on18 March 2021

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