A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04121221|
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis, Relapsing-Remitting||Drug: GA Depot Other: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||960 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
During the placebo controlled period 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 for an additional 52 weeks, in which all subjects will receive 40mg of GA Depot IM once every 4 weeks.
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||September 19, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
Experimental: GA Depot
Monthly IM injection
Drug: GA Depot
Long acting intramuscular injection of glatiramer acetate, once every 4 weeks
Placebo Comparator: Placebo
Monthly IM injection
IM injection once every 4 weeks
- Annualized Relapse Rate (ARR) [ Time Frame: 52 weeks ]Annualized Relapse Rate (ARR) will be derived from the total number of confirmed relapses.
- Changes in brain MRI (number of T1 lesions) [ Time Frame: 52 weeks ]Cumulative number of new enhancing lesions on T1-weighted images as compared to baseline.
- Changes in brain MRI (number of T2 lesions) [ Time Frame: 52 weeks ]Cumulative number of new or newly enlarging hyperintense T2 lesions as compared to baseline.
- Hyperintense T2-lesion volume change [ Time Frame: 52 weeks ]Change from baseline to Week 52 in hyperintense T2-lesion volume.
- Enhancing T1-lesion volume change [ Time Frame: 52 weeks ]Change from baseline to Week 52 in enhancing T1-lesion volume.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121221
|Contact: Laura Popper, MD||+972-737121213||GAD3@mapi-pharma.com|
|United States, Alabama|
|North Central Neurology Associates, PC||Recruiting|
|Cullman, Alabama, United States, 35058|
|Contact: Mitzi Roberts Mroberts@prn-inc.net|
|United States, Colorado|
|Mountain View Clinical Research, Inc.||Recruiting|
|Denver, Colorado, United States, 80209|
|Contact: Brian Johnson Brian@mtnresearch.com|
|Study Director:||Laura Popper, MD||Mapi Pharma Ltd.|
|Principal Investigator:||Aaron E. Miller, Prof. MD||Mount Sinai School of Medicine, New York, US|