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

Phase 3

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Other: Placebo; Drug: GA Depot

• Registration Number: NCT04121221
• Lead Sponsor: Mapi Pharma Ltd.

Brief 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.

Study Timeline

• Study Start: 2019-09-19
• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-09
• Primary Completion: 2023-06-13
• Study Completion: 2023-06-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1016

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Monthly IM injection
GA Depot	GA Depot	Monthly IM injection

Primary Outcome Measures

Name	Time	Method
Annualized Relapse Rate (ARR)	52 weeks	Annualized Relapse Rate (ARR) will be derived from the total number of confirmed relapses.

Secondary Outcome Measures

Name	Time	Method
Changes in brain MRI (number of T1 lesions)	52 weeks	Cumulative number of new enhancing lesions on T1-weighted images as compared to baseline.
Changes in brain MRI (number of T2 lesions)	52 weeks	Cumulative number of new or newly enlarging hyperintense T2 lesions as compared to baseline.
Hyperintense T2-lesion volume change	52 weeks	Change from baseline to Week 52 in hyperintense T2-lesion volume.
Enhancing T1-lesion volume change	52 weeks	Change from baseline to Week 52 in enhancing T1-lesion volume.

Trial Locations

Locations (33)

Mapi Pharma Research site 08; 🇺🇦 Kherson, Ukraine

Mapi Pharma Research site 11; 🇺🇦 Chernivtsi, Ukraine

Mapi Pharma Research site 15; 🇷🇺 Smolensk, Russian Federation

Mapi Pharma Research site 14; 🇺🇦 Poltava, Ukraine

Mapi Pharma Research site 12; 🇺🇦 Lviv, Ukraine

Mapi Pharma Research site 17; 🇺🇦 Luts'k, Ukraine

Mapi Pharma Research site 09; 🇺🇦 Kharkiv, Ukraine

Mapi Pharma Research site 01; 🇺🇦 Zaporizhzhya, Ukraine

Mapi Pharma Research site 02; 🇺🇦 Zaporizhzhya, Ukraine

Mapi Pharma Research site 13; 🇺🇦 Lviv, Ukraine

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