A Phase 3 interventional study of GA Depot and Placebo in Multiple Sclerosis, Relapsing-Remitting, sponsored by Mapi Pharma Ltd.. Completed at 112 sites in 10 countries. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Mapi Pharma Ltd. · Phase 3, Interventional, and Treatment
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
A total of 1016 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.
618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.
This study's enrollment of 1,016 is above the median of 66 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →Mapi Pharma Ltd. is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must have experienced at least one of the following:
i. At least one documented relapse in the 12 months prior to screening. ii. At least two documented relapses in the 24 months prior to screening. iii. One documented relapse between 12 and 24 months prior to screening, with at least one documented T1-Gd enhancing lesion in MRI performed within 0-12 months before screening.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Monthly IM injection
Drug: GA Depot
Monthly IM injection
Other: Placebo
Long acting intramuscular injection of glatiramer acetate, once every 4 weeks
IM injection once every 4 weeks
Annualized Relapse Rate (ARR)
ARR during the 52 weeks of the PC period as derived from the total number of confirmed relapses
Time frame: 52 weeks
Changes in Brain MRI (Number of T1 Lesions)
Cumulative number of new enhancing lesions on T1-weighted images as compared to baseline.
Time frame: 52 weeks
Changes in Brain MRI (Number of T2 Lesions)
Cumulative number of new or newly enlarging hyperintense T2 lesions as compared to baseline.
Time frame: 52 weeks
Hyperintense T2-lesion Volume Change
Change from baseline to Week 52 in hyperintense T2-lesion volume.
Time frame: 52 weeks
Enhancing T1-lesion Volume Change
Change from baseline to Week 52 in enhancing T1-lesion volume.
Time frame: 52 weeks
A total of 1108 participants were screened in this study, and 92 participants failed screening. Of these, 92 did not meet eligibility criteria.
| Milestone | Early Start: GA Depot 40 mg | Delayed Start: Placebo |
|---|---|---|
| Started | 508 | 508 |
| Completed | 379 | 442 |
| Not completed | 129 | 66 |
| Milestone | Early Start: GA Depot 40 mg | Delayed Start: Placebo |
|---|---|---|
| Started | 347 | 416 |
| Completed | 293 | 332 |
| Not completed | 54 | 84 |
Cumulative number of new enhancing lesions on T1-weighted images as compared to baseline.
| Lesions | Early Start: GA Depot 40 mg | Delayed Start: Placebo |
|---|---|---|
| Changes in Brain MRI (Number of T1 Lesions) | 1.528 ± 0.152 | 2.138 ± 0.211 |
Cumulative number of new or newly enlarging hyperintense T2 lesions as compared to baseline.
| Lesions | Early Start: GA Depot 40 mg | Delayed Start: Placebo |
|---|---|---|
| Changes in Brain MRI (Number of T2 Lesions) | 3.816 ± 0.305 | 4.470 ± 0.349 |
Change from baseline to Week 52 in hyperintense T2-lesion volume.
| μl | Early Start: GA Depot 40 mg | Delayed Start: Placebo |
|---|---|---|
| Hyperintense T2-lesion Volume Change | -404.873 ± 123.518 | -287.953 ± 116.852 |
Change from baseline to Week 52 in enhancing T1-lesion volume.
| μl | Early Start: GA Depot 40 mg | Delayed Start: Placebo |
|---|---|---|
| Enhancing T1-lesion Volume Change | -10.270 ± 20.972 | 0.697 ± 19.633 |
Post hoc analysis - Cumulative number of new or newly enlarging hyperintense T2 lesions as compared to baseline (over-dispersed Poisson regression model)
| Lesions | Early Start: GA Depot 40 mg | Delayed Start: Placebo |
|---|---|---|
| Changes in Brain MRI (Number of T2 Lesions) | 3.743 ± 0.302 | 4.527 ± 0.336 |
ARR during the 52 weeks of the PC period as derived from the total number of confirmed relapses
| Relapses per participant per year | Early Start: GA Depot 40 mg | Delayed Start: Placebo |
|---|---|---|
| Annualized Relapse Rate (ARR) | 0.182 ± 0.022 | 0.260 ± 0.029 |
Collected over Placebo controlled (PC) period Day 1 to Month 12 Open label (OL) period Month 12 to Month 24 Early Start: (GA Depot 40 mg, PC period) Day 1 up to Month 12 Delayed start: (Placebo, PC period) Day 1 to Month 12 Early Start: (GA 40 Depot mg, OL period) Month 12 up to Month 24 Delayed Start: (GA Depot 40 mg, OL period) Month 12 up to Month 24. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Early Start: GA Depot 40 mg - PC Period | 0/508 (0%) | 24/508 (4.7%) | 320/508 (63%) |
| Delayed Start: Placebo - PC Period | 2/508 (0.4%) | 9/508 (1.8%) | 230/508 (45.3%) |
| Early Start: GA 40 Depot mg - OL Period | 0/347 (0%) | 4/347 (1.2%) | 107/347 (30.8%) |
| Delayed Start: GA Depot 40 mg - OL Period | 0/416 (0%) | 10/416 (2.4%) | 139/416 (33.4%) |
| Event | Early Start: GA Depot 40 mg - PC Period | Delayed Start: Placebo - PC Period | Early Start: GA 40 Depot mg - OL Period | Delayed Start: GA Depot 40 mg - OL Period |
|---|---|---|---|---|
| COVID-19 pneumoniaInfections and infestations | 4/508 | 1/508 | 0/347 | 0/416 |
| Injection site abscessInfections and infestations | 0/508 | 0/508 | 0/347 | 3/416 |
| Erythema nodosumSkin and subcutaneous tissue disorders | 3/508 | 0/508 | 0/347 | 1/416 |
| PneumoniaInfections and infestations | 2/508 | 0/508 | 0/347 | 0/416 |
| Coronavirus infectionInfections and infestations | 1/508 | 2/508 | 0/347 | 1/416 |
| Tubulointerstitial nephritisRenal and urinary disorders | 2/508 | 0/508 | 0/347 | 0/416 |
| Abscess limbInfections and infestations | 1/508 | 0/508 | 1/347 | 0/416 |
| HIV infectionInfections and infestations | 0/508 | 0/508 | 1/347 | 0/416 |
| TonsilitisInfections and infestations | 0/508 | 0/508 | 1/347 | 0/416 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/508 | 0/508 | 1/347 | 0/416 |
| Event | Early Start: GA Depot 40 mg - PC Period | Delayed Start: Placebo - PC Period | Early Start: GA 40 Depot mg - OL Period | Delayed Start: GA Depot 40 mg - OL Period |
|---|---|---|---|---|
| Injection site painGeneral disorders | 149/508 | 112/508 | 38/347 | 44/416 |
| PyrexiaGeneral disorders | 108/508 | 28/508 | 24/347 | 31/416 |
| Injection site indurationGeneral disorders | 90/508 | 43/508 | 30/347 | 46/416 |
| Body temperature increasedInvestigations | 77/508 | 32/508 | 32/347 | 33/416 |
| HeadacheNervous system disorders | 28/508 | 51/508 | 16/347 | 23/416 |
| Influenza like illnessGeneral disorders | 44/508 | 15/508 | 21/347 | 30/416 |
| Coronavirus infectionInfections and infestations | 40/508 | 41/508 | 16/347 | 20/416 |
| Injection site erythemaGeneral disorders | 37/508 | 18/508 | 5/347 | 13/416 |
| Injection site swellingGeneral disorders | 32/508 | 11/508 | 9/347 | 7/416 |
| Injection site massGeneral disorders | 30/508 | 13/508 | 5/347 | 3/416 |
| Age, Continuous(Years) | Early Start: GA Depot 40 mg | Delayed Start: Placebo | Total |
|---|---|---|---|
| Mean | 36.7 ± 9.08 | 36.9 ± 9.33 | 36.8 ± 9.20 |
| Sex: Female, Male(Participants) | Early Start: GA Depot 40 mg | Delayed Start: Placebo | Total |
|---|---|---|---|
| Female | 345 | 361 | 706 |
| Male | 163 | 147 | 310 |
| Race (NIH/OMB)(Participants) | Early Start: GA Depot 40 mg | Delayed Start: Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 508 | 508 | 1016 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Early Start: GA Depot 40 mg | Delayed Start: Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 5 | 7 |
| Not Hispanic or Latino | 501 | 501 | 1002 |
| Unknown or Not Reported | 5 | 2 | 7 |
| Body Mass Index (BMI)(kg/m^2) | Early Start: GA Depot 40 mg | Delayed Start: Placebo | Total |
|---|---|---|---|
| Mean | 23.96 ± 4.44 | 24.17 ± 4.78 | 24.07 ± 4.61 |
| Time from Onset of MS Symptom(Years) | Early Start: GA Depot 40 mg | Delayed Start: Placebo | Total |
|---|---|---|---|
| Mean | 7.33 ± 6.24 | 6.94 ± 6.45 | 7.14 ± 6.34 |
| Time since date of RMS diagnosis(Years) | Early Start: GA Depot 40 mg | Delayed Start: Placebo | Total |
|---|---|---|---|
| Mean | 4.86 ± 5.42 | 4.76 ± 5.52 | 4.81 ± 5.47 |
| Number of T1 Enhancing Lesions at Baseline(Lesions) | Early Start: GA Depot 40 mg | Delayed Start: Placebo | Total |
|---|---|---|---|
| Mean | 1.21 ± 2.11 | 1.17 ± 2.09 | 1.19 ± 2.10 |
1 further baseline measures are reported on the registry.
Showing the first 100 of 112 sites across 10 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Multiple Sclerosis, Relapsing-Remitting →
Mapi Pharma Ltd.