Multiple Sclerosis, Relapsing-RemittingPhase 3NCT04121221
A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
A Phase 3 study testing GA Depot in people with Multiple Sclerosis, Relapsing-Remitting, run by Mapi Pharma Ltd. at 112 sites in 10 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- GA Depot
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,016 participants
- Where
- 112 sitesin 10 countries
- Study dates
- 19 Sep 2019to 13 Jun 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult subjects between 18-55 years of age, inclusive.
- Subjects able to provide signed written informed consent.
- Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
- MS diagnosis fulfilling the 2017 McDonald Criteria.
- Subjects should be ambulatory with an EDSS score of 0-5.5 at screening and baseline visits. EDSS score will be determined by a separate, blinded trained EDSS rater.
- Subjects should be relapse free and neurologically stable from one month before screening visit and from screening visit to baseline visit.
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- No systemic corticosteroid treatment or ACTH within one month prior to screening visit.
- Subjects must have experienced at least one of the following:
- 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.
- Women capable of child bearing must have a negative urine pregnancy test at screening and baseline visit and use an adequate contraceptive method throughout the study.
Who cannot join
- Use of experimental / investigational drug, and / or participation in drug clinical studies within the 6 months prior to screening.
- Any off-label drug use for MS treatment such as high dose simvastatin and biotin within 6 months prior to screening.
- Previous use of immunosuppressant including Mitoxantrone, Alemtuzumab, Cladribine or any other cytotoxic agent within 5 years.
- Previous use of Natalizumab or any anti-B cell agent within 9 months prior to screening.
- Previous use of Fingolimod or any other sphingosine-1-phosphate receptor modulator, Dimethyl Fumarate, Diroximel Fumarate (DRF), or Monomethyl fumarate within 2 months prior to screening. Subjects will be excluded if they do not have a lymphocyte count of above 1,000/mm3 at screening.
- Previous use of Teriflunomide within 12 months if no accelerated elimination procedure was used.
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- Previous treatment with immunomodulators (including IFNβ 1a and 1b, and IV Immunoglobulin (IVIg) within 2 months prior to screening.
- Previous use of GA or any other glatiramoid.
- Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
- Previous total body irradiation or total lymphoid irradiation.
- Previous stem-cell treatment, autologous bone marrow transplantation or allogeneic bone marrow transplantation.
- Subjects with a clinically significant or unstable medical, psychiatric, or surgical conditions that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG and/or abnormal laboratory tests; and or subjects with an increased risk of serious Covid-19 related morbidity. Such conditions may include hepatic, renal or metabolic diseases, systemic disease, acute infection, current malignancy, or recent history (5 years) of malignancy, major psychiatric disorder, history of drug and/or alcohol abuse and allergies that could be detrimental according to the investigator's judgment.
- Subjects who have >10 T1-Gd enhancing lesions at screening.
- A known history of sensitivity to Gadolinium.
- Inability to successfully undergo MRI scanning.
- Pregnant or breast-feeding women.
- Abnormal renal function.
- Abnormal liver function.
- History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study article (e.g., GA, Polyglactin, PVA).
- Positive testing or a history of positive testing for syphilis, HIV, hepatitis, or tuberculosis.
- Known or suspected history of drug or alcohol abuse.
- Subjects diagnosed with any systemic autoimmune disease (other than MS) that may impact the CNS with MS like lesions such as Sarcoidosis, Sjögren's syndrome, Systemic Lupus Erythematosus (SLE), Lyme disease, Antiphospholipid antibodies (APLA) syndrome, etc. Subjects with stable local/organ autoimmune disease such as psoriasis, cutaneous lupus erythematosus, thyroiditis (Hashimoto's, Grave's) etc. may be considered eligible upon the investigator's discretion.
- Any CNS disorder other than MS that may jeopardize the subject's participation in the study.
- Subjects with uncontrolled diabetes.
- Subjects with clotting disorders or receiving treatment with anticoagulants.
Trial locations and contacts
112 sites in 10 countries.
112 sites in 10 countries
Ukraine30 sites
Mapi Pharma Research site 32
Cherkasy
Mapi Pharma Research site 06
Chernihiv
Mapi Pharma Research site 11
Chernivtsi
Mapi Pharma Research site 03
Dnipro
Mapi Pharma Research site 04
Dnipro
Mapi Pharma Research site 24
Dnipro
Mapi Pharma Research site 18
Ivano-Frankivsk
Mapi Pharma Research site 26
Ivano-Frankivsk
Mapi Pharma Research site 27
Ivano-Frankivsk
Mapi Pharma Research site 09
Kharkiv
Mapi Pharma Research site 10
Kharkiv
Mapi Pharma Research site 08
Kherson
Mapi Pharma Research site 21
Kyiv
Mapi Pharma Research site 25
Kyiv
Mapi Pharma Research site 28
Kyiv
Mapi Pharma Research site 29
Kyiv
Mapi Pharma Research site 17
Lutsk
Mapi Pharma Research site 12
Lviv
Mapi Pharma Research site 13
Lviv
Mapi Pharma Research site 23
Lviv
Mapi Pharma Research site 05
Odesa
Mapi Pharma Research site 14
Poltava
Mapi Pharma Research site 34
Ternopil
Mapi Pharma Research site 31
Uzhhorod
Mapi Pharma Research site 16
Vinnitsa
Mapi Pharma Research site 01
Zaporizhzhya
Mapi Pharma Research site 02
Zaporizhzhya
Mapi Pharma Research site 07
Zaporizhzhya
Mapi Pharma Research site 20
Zaporizhzhya
Mapi Pharma Research site 33
Zhytomyr
Russia28 sites
Mapi Pharma Research site 29
Barnaul
Mapi Pharma Research site 27
Bryansk
Mapi Pharma Research site 23
Chelyabinsk
Mapi Pharma Research site 01
Kazan'
Mapi Pharma Research site 19
Kemerovo
Mapi Pharma Research site 24
Krasnodar
Mapi Pharma Research site 03
Moscow
Mapi Pharma Research site 13
Moscow
Mapi Pharma Research site 14
Moscow
Mapi Pharma Research site 21
Moscow
Mapi Pharma Research site 25
Moscow
Mapi Pharma Research site 28
Moscow
Mapi Pharma Research site 02
Nizhny Novgorod
Mapi Pharma Research site 07
Nizhny Novgorod
Mapi Pharma Research site 10
Nizhny Novgorod
Mapi Pharma Research site 11
Novosibirsk
Mapi Pharma Research site 06
Perm
Mapi Pharma Research site 22
Pyatigorsk
Mapi Pharma Research site 08
Rostov-on-Don
Mapi Pharma Research site 09
Saint Petersburg
Mapi Pharma Research site 18
Saint Petersburg
Mapi Pharma Research site 20
Saint Petersburg
Mapi Pharma Research site 05
Samara
Mapi Pharma Research site 26
Saransk
Mapi Pharma Research site 15
Smolensk
Mapi Pharma Research site 16
Tyumen
Mapi Pharma Research site 04
Ufa
Mapi Pharma Research site 17
Ulyanovsk
Bulgaria19 sites
Mapi Pharma Research site 14
Haskovo
Mapi Pharma Research site 10
Pazardzhik
Mapi Pharma Research site 01
Pleven
Mapi Pharma Research site 02
Pleven
Mapi Pharma Research site 03
Pleven
Mapi Pharma Research site 07
Pleven
Mapi Pharma Research site 12
Plovdiv
Mapi Pharma Research site 18
Rousse
Mapi Pharma Research site 04
Sofia
Mapi Pharma Research site 05
Sofia
Mapi Pharma Research site 06
Sofia
Mapi Pharma Research site 08
Sofia
Mapi Pharma Research site 11
Sofia
Mapi Pharma Research site 13
Sofia
Mapi Pharma Research site 15
Sofia
Mapi Pharma Research site 16
Sofia
Mapi Pharma Research site 19
Sofia
Mapi Pharma Research site 09
Veliko Tarnovo
Mapi Pharma Research site 17
Vratsa
United States11 sites
Mapi Pharma Research site 08
Birmingham, Alabama, 35209
Mapi Pharma Research site 11
Cullman, Alabama, 35058
Mapi Pharma Research site 14
Denver, Colorado, 80209
Mapi Pharma Research site 02
Detroit, Michigan, 48201
Mapi Pharma Research site 17
Homestead, Florida, 33032
Mapi Pharma Research site 09
Miami, Florida, 33136
Mapi Pharma Research site 01
Northbrook, Illinois, 60062
Mapi Pharma Research site 15
Pasadena, California, 91105
Mapi Pharma Research site 04
Round Rock, Texas, 78681
Mapi Pharma Research site 12
Washington D.C., District of Columbia, 20007
Mapi Pharma Research site 13
Westerville, Ohio, 43081
Georgia9 sites
Mapi Pharma Research site 01
Tbilisi
Mapi Pharma Research site 02
Tbilisi
Mapi Pharma Research site 03
Tbilisi
Mapi Pharma Research site 04
Tbilisi
Mapi Pharma Research site 05
Tbilisi
Mapi Pharma Research site 06
Tbilisi
Mapi Pharma Research site 07
Tbilisi
Mapi Pharma Research site 08
Tbilisi
Mapi Pharma Research site 09
Tbilisi
Belarus6 sites
Mapi Pharma Research site 02
Homyel
Mapi Pharma Research site 04
Minsk
Mapi Pharma Research site 05
Minsk
Mapi Pharma Research site 06
Minsk
Mapi Pharma Research site 01
Vitebsk
Mapi Pharma Research site 07
Vitebsk
Bosnia and Herzegovina4 sites
Mapi Pharma Research site 04
Banja Luka
Mapi Pharma Research site 06
Bihać
Mapi Pharma Research site 01
Sarajevo
Mapi Pharma Research site 03
Tuzla
Israel2 sites
Mapi Pharma Research site 01
Safed
Mapi Pharma Research site 02
Tel Aviv
Moldova2 sites
Mapi Pharma Research site 01
Chisinau
Mapi Pharma Research site 02
Chisinau
About this study
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
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
Read the detailed description
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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- GA Depot, Placebo
- Keywords
- Multiple Sclerosis, RMS, GA Depot, Multiple Sclerosis, Relapsing-Remitting
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GA DepotDrug
Long acting intramuscular injection of glatiramer acetate, once every 4 weeks
PlaceboOther
IM injection once every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| GA Depot | Experimental | Monthly IM injection Receives: Drug: GA Depot |
| Placebo | Placebo comparator | Monthly IM injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Relapse Rate (ARR)
ARR during the 52 weeks of the PC period as derived from the total number of confirmed relapses
Measured: 52 weeks
Secondary outcomes (4)
Changes in Brain MRI (Number of T1 Lesions)
Cumulative number of new enhancing lesions on T1-weighted images as compared to baseline.
Measured: 52 weeks
Changes in Brain MRI (Number of T2 Lesions)
Cumulative number of new or newly enlarging hyperintense T2 lesions as compared to baseline.
Measured: 52 weeks
Hyperintense T2-lesion Volume Change
Change from baseline to Week 52 in hyperintense T2-lesion volume.
Measured: 52 weeks
Enhancing T1-lesion Volume Change
Change from baseline to Week 52 in enhancing T1-lesion volume.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start19 Sep 2019
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,016 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mapi Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Popper, MD, Study director, Mapi Pharma Ltd.Aaron E. Miller, Prof. MD, Principal investigator, Mount Sinai School of Medicine, New York, US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121221
- Sponsor's protocol ID
- Mapi GA Depot Phase III - 001
- Status last verified
- Jul 2026
- First submitted
- 8 Oct 2019
- Last updated
- 5 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Miller A, Cohen JA, Karni A, Popper L, Bleich Kimelman N, Rubnov S, Danon U, Marom E, Boyko A, Zivadinov R, Berger JR, Bar-Or A, Kolb H. GA Depot, a long-acting glatiramer acetate, vs placebo in patients with relapsing multiple sclerosis: A randomized phase 3 clinical trial. Mult Scler. 2026 Feb;32(2):202-213. doi: 10.1177/13524585251405101. Epub 2026 Feb 18.
PubMed 41705515