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Can a Once-a-Month shot tame MS relapses?

NCT ID NCT04121221

Disease control Sponsor: Mapi Pharma Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This phase III trial is testing whether a long-acting form of glatiramer acetate, called GA Depot, given as a monthly injection, can reduce the number of relapses in people with relapsing-remitting multiple sclerosis (MS). The study involves about 1,000 adults aged 18 to 55 with MS, who will receive either GA Depot or a placebo injection every four weeks for a year. Researchers will track relapse rates and brain MRI changes to see if this less frequent dosing is effective and safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GA Depot, a long-acting form of glatiramer acetate given as an intramuscular injection once every four weeks
What this could lead to
If successful, this could offer a more convenient treatment option for relapsing-remitting MS, potentially reducing relapse rates with fewer injections.
What could go wrong
The trial is still in phase III, and results may not confirm benefit. Possible risks include injection-site reactions and other side effects common to glatiramer acetate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,016 people

The number who actually took part.

Started

Sep 2019

Finished

Jun 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. Adult subjects between 18-55 years of age, inclusive. 2. Subjects able to provide signed written informed consent. 3. Subjects must be willing and able to comply with the protocol requirements for the duration of the study. 4. MS diagnosis fulfilling the 2017 McDonald Criteria. 5. 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. 6. Subjects should be relapse free and neurologically stable from one month before screening visit and from screening visit to baseline visit. 7. No systemic corticosteroid treatment or ACTH within one month prior to screening visit. 8. 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. 9. 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. Exclusion criteria: 1. Use of experimental / investigational drug, and / or participation in drug clinical studies within the 6 months prior to screening. 2. Any off-label drug use for MS treatment such as high dose simvastatin and biotin within 6 months prior to screening. 3. Previous use of immunosuppressant including Mitoxantrone, Alemtuzumab, Cladribine or any other cytotoxic agent within 5 years. 4. Previous use of Natalizumab or any anti-B cell agent within 9 months prior to screening. 5. 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. 6. Previous use of Teriflunomide within 12 months if no accelerated elimination procedure was used. 7. Previous treatment with immunomodulators (including IFNβ 1a and 1b, and IV Immunoglobulin (IVIg) within 2 months prior to screening. 8. Previous use of GA or any other glatiramoid. 9. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit. 10. Previous total body irradiation or total lymphoid irradiation. 11. Previous stem-cell treatment, autologous bone marrow transplantation or allogeneic bone marrow transplantation. 12. 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. 13. Subjects who have \>10 T1-Gd enhancing lesions at screening. 14. A known history of sensitivity to Gadolinium. 15. Inability to successfully undergo MRI scanning. 16. Pregnant or breast-feeding women. 17. Abnormal renal function. 18. Abnormal liver function. 19. 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). 20. Positive testing or a history of positive testing for syphilis, HIV, hepatitis, or tuberculosis. 21. Known or suspected history of drug or alcohol abuse. 22. 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. 23. Any CNS disorder other than MS that may jeopardize the subject's participation in the study. 24. Subjects with uncontrolled diabetes. 25. Subjects with clotting disorders or receiving treatment with anticoagulants.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis, relapsing-remitting

Contacts and locations

Locations

  • Mapi Pharma Research site 01

    Northbrook, Illinois, 60062, United States

  • Mapi Pharma Research site 01

    Vitebsk, Belarus

  • Mapi Pharma Research site 01

    Sarajevo, Bosnia and Herzegovina

  • Mapi Pharma Research site 01

    Pleven, Bulgaria

  • Mapi Pharma Research site 01

    Tallinn, Estonia

  • Mapi Pharma Research site 01

    Tbilisi, Georgia

  • Mapi Pharma Research site 01

    Safed, Israel

  • Mapi Pharma Research site 01

    Chisinau, Moldova

  • Mapi Pharma Research site 01

    Kazan', Russia

  • Mapi Pharma Research site 01

    Zaporizhzhya, Ukraine

  • Mapi Pharma Research site 02

    Detroit, Michigan, 48201, United States

  • Mapi Pharma Research site 02

    Homyel, Belarus

  • Mapi Pharma Research site 02

    Pleven, Bulgaria

  • Mapi Pharma Research site 02

    Tbilisi, Georgia

  • Mapi Pharma Research site 02

    Tel Aviv, Israel

  • Mapi Pharma Research site 02

    Chisinau, Moldova

  • Mapi Pharma Research site 02

    Nizhny Novgorod, Russia

  • Mapi Pharma Research site 02

    Zaporizhzhya, Ukraine

  • Mapi Pharma Research site 03

    Tuzla, Bosnia and Herzegovina

  • Mapi Pharma Research site 03

    Pleven, Bulgaria

  • Mapi Pharma Research site 03

    Tbilisi, Georgia

  • Mapi Pharma Research site 03

    Moscow, Russia

  • Mapi Pharma Research site 03

    Dnipro, Ukraine

  • Mapi Pharma Research site 04

    Round Rock, Texas, 78681, United States

  • Mapi Pharma Research site 04

    Minsk, Belarus

  • Mapi Pharma Research site 04

    Banja Luka, Bosnia and Herzegovina

  • Mapi Pharma Research site 04

    Sofia, Bulgaria

  • Mapi Pharma Research site 04

    Tbilisi, Georgia

  • Mapi Pharma Research site 04

    Ufa, Russia

  • Mapi Pharma Research site 04

    Dnipro, Ukraine

  • Mapi Pharma Research site 05

    Minsk, Belarus

  • Mapi Pharma Research site 05

    Sofia, Bulgaria

  • Mapi Pharma Research site 05

    Tbilisi, Georgia

  • Mapi Pharma Research site 05

    Samara, Russia

  • Mapi Pharma Research site 05

    Odesa, Ukraine

  • Mapi Pharma Research site 06

    Minsk, Belarus

  • Mapi Pharma Research site 06

    Bihać, Bosnia and Herzegovina

  • Mapi Pharma Research site 06

    Sofia, Bulgaria

  • Mapi Pharma Research site 06

    Tbilisi, Georgia

  • Mapi Pharma Research site 06

    Perm, Russia

  • Mapi Pharma Research site 06

    Chernihiv, Ukraine

  • Mapi Pharma Research site 07

    Vitebsk, Belarus

  • Mapi Pharma Research site 07

    Pleven, Bulgaria

  • Mapi Pharma Research site 07

    Tbilisi, Georgia

  • Mapi Pharma Research site 07

    Nizhny Novgorod, Russia

  • Mapi Pharma Research site 07

    Zaporizhzhya, Ukraine

  • Mapi Pharma Research site 08

    Birmingham, Alabama, 35209, United States

  • Mapi Pharma Research site 08

    Sofia, Bulgaria

  • Mapi Pharma Research site 08

    Tbilisi, Georgia

  • Mapi Pharma Research site 08

    Rostov-on-Don, Russia

  • Mapi Pharma Research site 08

    Kherson, Ukraine

  • Mapi Pharma Research site 09

    Miami, Florida, 33136, United States

  • Mapi Pharma Research site 09

    Veliko Tarnovo, Bulgaria

  • Mapi Pharma Research site 09

    Tbilisi, Georgia

  • Mapi Pharma Research site 09

    Saint Petersburg, Russia

  • Mapi Pharma Research site 09

    Kharkiv, Ukraine

  • Mapi Pharma Research site 10

    Pazardzhik, Bulgaria

  • Mapi Pharma Research site 10

    Nizhny Novgorod, Russia

  • Mapi Pharma Research site 10

    Kharkiv, Ukraine

  • Mapi Pharma Research site 11

    Cullman, Alabama, 35058, United States

  • Mapi Pharma Research site 11

    Sofia, Bulgaria

  • Mapi Pharma Research site 11

    Novosibirsk, Russia

  • Mapi Pharma Research site 11

    Chernivtsi, Ukraine

  • Mapi Pharma Research site 12

    Washington D.C., District of Columbia, 20007, United States

  • Mapi Pharma Research site 12

    Plovdiv, Bulgaria

  • Mapi Pharma Research site 12

    Lviv, Ukraine

  • Mapi Pharma Research site 13

    Westerville, Ohio, 43081, United States

  • Mapi Pharma Research site 13

    Sofia, Bulgaria

  • Mapi Pharma Research site 13

    Moscow, Russia

  • Mapi Pharma Research site 13

    Lviv, Ukraine

  • Mapi Pharma Research site 14

    Denver, Colorado, 80209, United States

  • Mapi Pharma Research site 14

    Haskovo, Bulgaria

  • Mapi Pharma Research site 14

    Moscow, Russia

  • Mapi Pharma Research site 14

    Poltava, Ukraine

  • Mapi Pharma Research site 15

    Pasadena, California, 91105, United States

  • Mapi Pharma Research site 15

    Sofia, Bulgaria

  • Mapi Pharma Research site 15

    Smolensk, Russia

  • Mapi Pharma Research site 16

    Sofia, Bulgaria

  • Mapi Pharma Research site 16

    Tyumen, Russia

  • Mapi Pharma Research site 16

    Vinnitsa, Ukraine

  • Mapi Pharma Research site 17

    Homestead, Florida, 33032, United States

  • Mapi Pharma Research site 17

    Vratsa, Bulgaria

  • Mapi Pharma Research site 17

    Ulyanovsk, Russia

  • Mapi Pharma Research site 17

    Lutsk, Ukraine

  • Mapi Pharma Research site 18

    Rousse, Bulgaria

  • Mapi Pharma Research site 18

    Saint Petersburg, Russia

  • Mapi Pharma Research site 18

    Ivano-Frankivsk, Ukraine

  • Mapi Pharma Research site 19

    Sofia, Bulgaria

  • Mapi Pharma Research site 19

    Kemerovo, Russia

  • Mapi Pharma Research site 20

    Saint Petersburg, Russia

  • Mapi Pharma Research site 20

    Zaporizhzhya, Ukraine

  • Mapi Pharma Research site 21

    Moscow, Russia

  • Mapi Pharma Research site 21

    Kyiv, Ukraine

  • Mapi Pharma Research site 22

    Pyatigorsk, Russia

  • Mapi Pharma Research site 23

    Chelyabinsk, Russia

  • Mapi Pharma Research site 23

    Lviv, Ukraine

  • Mapi Pharma Research site 24

    Krasnodar, Russia

  • Mapi Pharma Research site 24

    Dnipro, Ukraine

  • Mapi Pharma Research site 25

    Moscow, Russia

  • Mapi Pharma Research site 25

    Kyiv, Ukraine

  • Mapi Pharma Research site 26

    Saransk, Russia

  • Mapi Pharma Research site 26

    Ivano-Frankivsk, Ukraine

  • Mapi Pharma Research site 27

    Bryansk, Russia

  • Mapi Pharma Research site 27

    Ivano-Frankivsk, Ukraine

  • Mapi Pharma Research site 28

    Moscow, Russia

  • Mapi Pharma Research site 28

    Kyiv, Ukraine

  • Mapi Pharma Research site 29

    Barnaul, Russia

  • Mapi Pharma Research site 29

    Kyiv, Ukraine

  • Mapi Pharma Research site 31

    Uzhhorod, Ukraine

  • Mapi Pharma Research site 32

    Cherkasy, Ukraine

  • Mapi Pharma Research site 33

    Zhytomyr, Ukraine

  • Mapi Pharma Research site 34

    Ternopil, Ukraine

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