A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Interventions
- Other: Placebo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1016
Not provided
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 14
🇺🇦Poltava, Ukraine
Mapi Pharma Research site 17
🇺🇦Luts'k, Ukraine
Mapi Pharma Research site 28
🇺🇦Kyiv, Ukraine
Mapi Pharma Research site 05
🇺🇦Odesa, Ukraine
Mapi Pharma Research site 01
🇺🇦Zaporizhzhya, Ukraine
Mapi Pharma Research site 16
🇺🇦Vinnitsa, Ukraine
Mapi Pharma Research site 23
🇺🇦Lviv, Ukraine
Mapi Pharma Research site 24
🇺🇦Dnipro, Ukraine
Mapi Pharma Research site 08
🇺🇦Kherson, Ukraine
Mapi Pharma Research site 15
🇷🇺Smolensk, Russian Federation
Mapi Pharma Research site 12
🇺🇦Lviv, Ukraine
Mapi Pharma Research site 09
🇺🇦Kharkiv, Ukraine
Mapi Pharma Research site 21
🇺🇦Kyiv, Ukraine
Mapi Pharma Research site 32
🇺🇦Cherkasy, Ukraine
Mapi Pharma Research site 31
🇺🇦Úzhgorod, Ukraine
Mapi Pharma Research site 10
🇺🇦Kharkiv, Ukraine
Mapi Pharma Research site 07
🇺🇦Zaporizhzhya, Ukraine
Mapi Pharma Research site 22
🇷🇺Pyatigorsk, Russian Federation
Mapi Pharma Research site 18
🇺🇦Ivano-Frankivs'k, Ukraine
Mapi Pharma Research site 19
🇷🇺Kemerovo, Russian Federation
Mapi Pharma Research site 11
🇺🇦Chernivtsi, Ukraine
Mapi Pharma Research site 02
🇺🇦Zaporizhzhya, Ukraine
Mapi Pharma Research site 13
🇺🇦Lviv, Ukraine
Mapi Pharma Research site 04
🇺🇦Dnipropetrovs'k, Ukraine
Mapi Pharma Research site 06
🇺🇦Chernihiv, Ukraine
Mapi Pharma Research site 03
🇺🇦Dnipropetrovs'k, Ukraine
Mapi Pharma Research site 27
🇺🇦Ivano-Frankivs'k, Ukraine
Mapi Pharma Research site 34
🇺🇦Ternopil', Ukraine
Mapi Pharma Research site 29
🇺🇦Kyiv, Ukraine
Mapi Pharma Research site 25
🇺🇦Kyiv, Ukraine
Mapi Pharma Research site 20
🇺🇦Zaporizhzhya, Ukraine
Mapi Pharma Research site 33
🇺🇦Zhytomyr, Ukraine
Mapi Pharma Research site 26
🇺🇦Ivano-Frankivs'k, Ukraine