A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
NCT ID: NCT04121221
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1016 participants
INTERVENTIONAL
2019-09-19
2023-06-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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.
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GA Depot
Monthly IM injection
GA Depot
Long acting intramuscular injection of glatiramer acetate, once every 4 weeks
Placebo
Monthly IM injection
Placebo
IM injection once every 4 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GA Depot
Long acting intramuscular injection of glatiramer acetate, once every 4 weeks
Placebo
IM injection once every 4 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mapi Pharma Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Laura Popper, MD
Role: STUDY_DIRECTOR
Mapi Pharma Ltd.
Aaron E. Miller, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai School of Medicine, New York, US
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mapi Pharma Research site 08
Birmingham, Alabama, United States
Mapi Pharma Research site 11
Cullman, Alabama, United States
Mapi Pharma Research site 15
Pasadena, California, United States
Mapi Pharma Research site 14
Denver, Colorado, United States
Mapi Pharma Research site 12
Washington D.C., District of Columbia, United States
Mapi Pharma Research site 17
Homestead, Florida, United States
Mapi Pharma Research site 09
Miami, Florida, United States
Mapi Pharma Research site 01
Northbrook, Illinois, United States
Mapi Pharma Research site 02
Detroit, Michigan, United States
Mapi Pharma Research site 13
Westerville, Ohio, United States
Mapi Pharma Research site 04
Round Rock, Texas, United States
Mapi Pharma Research site 02
Homyel, , Belarus
Mapi Pharma Research site 04
Minsk, , Belarus
Mapi Pharma Research site 05
Minsk, , Belarus
Mapi Pharma Research site 06
Minsk, , Belarus
Mapi Pharma Research site 01
Vitebsk, , Belarus
Mapi Pharma Research site 07
Vitebsk, , Belarus
Mapi Pharma Research site 04
Banja Luka, , Bosnia and Herzegovina
Mapi Pharma Research site 06
Bihać, , Bosnia and Herzegovina
Mapi Pharma Research site 01
Sarajevo, , Bosnia and Herzegovina
Mapi Pharma Research site 03
Tuzla, , Bosnia and Herzegovina
Mapi Pharma Research site 14
Haskovo, , Bulgaria
Mapi Pharma Research site 10
Pazardzhik, , Bulgaria
Mapi Pharma Research site 01
Pleven, , Bulgaria
Mapi Pharma Research site 02
Pleven, , Bulgaria
Mapi Pharma Research site 03
Pleven, , Bulgaria
Mapi Pharma Research site 07
Pleven, , Bulgaria
Mapi Pharma Research site 12
Plovdiv, , Bulgaria
Mapi Pharma Research site 18
Rousse, , Bulgaria
Mapi Pharma Research site 04
Sofia, , Bulgaria
Mapi Pharma Research site 05
Sofia, , Bulgaria
Mapi Pharma Research site 06
Sofia, , Bulgaria
Mapi Pharma Research site 08
Sofia, , Bulgaria
Mapi Pharma Research site 11
Sofia, , Bulgaria
Mapi Pharma Research site 13
Sofia, , Bulgaria
Mapi Pharma Research site 15
Sofia, , Bulgaria
Mapi Pharma Research site 16
Sofia, , Bulgaria
Mapi Pharma Research site 19
Sofia, , Bulgaria
Mapi Pharma Research site 09
Veliko Tarnovo, , Bulgaria
Mapi Pharma Research site 17
Vratsa, , Bulgaria
Mapi Pharma Research site 01
Tallinn, , Estonia
Mapi Pharma Research site 01
Tbilisi, , Georgia
Mapi Pharma Research site 02
Tbilisi, , Georgia
Mapi Pharma Research site 03
Tbilisi, , Georgia
Mapi Pharma Research site 04
Tbilisi, , Georgia
Mapi Pharma Research site 05
Tbilisi, , Georgia
Mapi Pharma Research site 06
Tbilisi, , Georgia
Mapi Pharma Research site 07
Tbilisi, , Georgia
Mapi Pharma Research site 08
Tbilisi, , Georgia
Mapi Pharma Research site 09
Tbilisi, , Georgia
Mapi Pharma Research site 01
Safed, , Israel
Mapi Pharma Research site 02
Tel Aviv, , Israel
Mapi Pharma Research site 01
Chisinau, , Moldova
Mapi Pharma Research site 02
Chisinau, , Moldova
Mapi Pharma Research site 29
Barnaul, , Russia
Mapi Pharma Research site 27
Bryansk, , Russia
Mapi Pharma Research site 23
Chelyabinsk, , Russia
Mapi Pharma Research site 01
Kazan', , Russia
Mapi Pharma Research site 19
Kemerovo, , Russia
Mapi Pharma Research site 24
Krasnodar, , Russia
Mapi Pharma Research site 03
Moscow, , Russia
Mapi Pharma Research site 13
Moscow, , Russia
Mapi Pharma Research site 14
Moscow, , Russia
Mapi Pharma Research site 21
Moscow, , Russia
Mapi Pharma Research site 25
Moscow, , Russia
Mapi Pharma Research site 28
Moscow, , Russia
Mapi Pharma Research site 02
Nizhny Novgorod, , Russia
Mapi Pharma Research site 07
Nizhny Novgorod, , Russia
Mapi Pharma Research site 10
Nizhny Novgorod, , Russia
Mapi Pharma Research site 11
Novosibirsk, , Russia
Mapi Pharma Research site 06
Perm, , Russia
Mapi Pharma Research site 22
Pyatigorsk, , Russia
Mapi Pharma Research site 08
Rostov-on-Don, , Russia
Mapi Pharma Research site 09
Saint Petersburg, , Russia
Mapi Pharma Research site 18
Saint Petersburg, , Russia
Mapi Pharma Research site 20
Saint Petersburg, , Russia
Mapi Pharma Research site 05
Samara, , Russia
Mapi Pharma Research site 26
Saransk, , Russia
Mapi Pharma Research site 15
Smolensk, , Russia
Mapi Pharma Research site 16
Tyumen, , Russia
Mapi Pharma Research site 04
Ufa, , Russia
Mapi Pharma Research site 17
Ulyanovsk, , Russia
Mapi Pharma Research site 32
Cherkasy, , Ukraine
Mapi Pharma Research site 06
Chernihiv, , Ukraine
Mapi Pharma Research site 11
Chernivtsi, , Ukraine
Mapi Pharma Research site 03
Dnipro, , Ukraine
Mapi Pharma Research site 04
Dnipro, , Ukraine
Mapi Pharma Research site 24
Dnipro, , Ukraine
Mapi Pharma Research site 18
Ivano-Frankivsk, , Ukraine
Mapi Pharma Research site 26
Ivano-Frankivsk, , Ukraine
Mapi Pharma Research site 27
Ivano-Frankivsk, , Ukraine
Mapi Pharma Research site 09
Kharkiv, , Ukraine
Mapi Pharma Research site 10
Kharkiv, , Ukraine
Mapi Pharma Research site 08
Kherson, , Ukraine
Mapi Pharma Research site 21
Kyiv, , Ukraine
Mapi Pharma Research site 25
Kyiv, , Ukraine
Mapi Pharma Research site 28
Kyiv, , Ukraine
Mapi Pharma Research site 29
Kyiv, , Ukraine
Mapi Pharma Research site 17
Lutsk, , Ukraine
Mapi Pharma Research site 12
Lviv, , Ukraine
Mapi Pharma Research site 13
Lviv, , Ukraine
Mapi Pharma Research site 23
Lviv, , Ukraine
Mapi Pharma Research site 05
Odesa, , Ukraine
Mapi Pharma Research site 14
Poltava, , Ukraine
Mapi Pharma Research site 34
Ternopil, , Ukraine
Mapi Pharma Research site 31
Uzhhorod, , Ukraine
Mapi Pharma Research site 16
Vinnitsa, , Ukraine
Mapi Pharma Research site 01
Zaporizhzhya, , Ukraine
Mapi Pharma Research site 02
Zaporizhzhya, , Ukraine
Mapi Pharma Research site 07
Zaporizhzhya, , Ukraine
Mapi Pharma Research site 20
Zaporizhzhya, , Ukraine
Mapi Pharma Research site 33
Zhytomyr, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Mapi GA Depot Phase III - 001
Identifier Type: -
Identifier Source: org_study_id