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NCT04121221

PHASE3

A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS

Sponsor: Mapi Pharma Ltd.

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

1016

Start Date

2019-09-19

Completion Date

2023-06-13

Last Updated

2026-08-05

Healthy Volunteers

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

DRUG

GA Depot

Long acting intramuscular injection of glatiramer acetate, once every 4 weeks

OTHER

Placebo

IM injection once every 4 weeks

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.

Locations (112)

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

Clinical Research Directory

A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (112)