- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04121221
A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A total of 1000 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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Gomel, Belarus
- Mapi Pharma Research site 02
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Minsk, Belarus
- Mapi Pharma Research site 04
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Minsk, Belarus
- Mapi Pharma Research site 05
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Minsk, Belarus
- Mapi Pharma Research site 06
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Vitebsk, Belarus
- Mapi Pharma Research site 01
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Vitebsk, Belarus
- Mapi Pharma Research site 07
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Banja Luka, Bosnia and Herzegovina
- Mapi Pharma Research site 04
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Bihać, Bosnia and Herzegovina
- Mapi Pharma Research site 06
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Sarajevo, Bosnia and Herzegovina
- Mapi Pharma Research site 01
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Tuzla, Bosnia and Herzegovina
- Mapi Pharma Research site 03
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Haskovo, Bulgaria
- Mapi Pharma Research site 14
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Pazardzhik, Bulgaria
- Mapi Pharma Research site 10
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Pleven, Bulgaria
- Mapi Pharma Research site 01
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Pleven, Bulgaria
- Mapi Pharma Research site 02
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Pleven, Bulgaria
- Mapi Pharma Research site 03
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Pleven, Bulgaria
- Mapi Pharma Research site 07
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Plovdiv, Bulgaria
- Mapi Pharma Research site 12
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Rousse, Bulgaria
- Mapi Pharma Research site 18
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Sofia, Bulgaria
- Mapi Pharma Research site 04
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Sofia, Bulgaria
- Mapi Pharma Research site 05
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Sofia, Bulgaria
- Mapi Pharma Research site 06
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Sofia, Bulgaria
- Mapi Pharma Research site 08
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Sofia, Bulgaria
- Mapi Pharma Research site 11
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Sofia, Bulgaria
- Mapi Pharma Research site 13
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Sofia, Bulgaria
- Mapi Pharma Research site 15
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Sofia, Bulgaria
- Mapi Pharma Research site 16
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Sofia, Bulgaria
- Mapi Pharma Research site 19
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Veliko Tarnovo, Bulgaria
- Mapi Pharma Research site 09
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Vratsa, Bulgaria
- Mapi Pharma Research site 17
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Tallinn, Estonia
- Mapi Pharma Research site 01
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Tbilisi, Georgia
- Mapi Pharma Research site 01
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Tbilisi, Georgia
- Mapi Pharma Research site 02
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Tbilisi, Georgia
- Mapi Pharma Research site 03
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Tbilisi, Georgia
- Mapi Pharma Research site 04
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Tbilisi, Georgia
- Mapi Pharma Research site 05
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Tbilisi, Georgia
- Mapi Pharma Research site 06
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Tbilisi, Georgia
- Mapi Pharma Research site 07
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Tbilisi, Georgia
- Mapi Pharma Research site 08
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Tbilisi, Georgia
- Mapi Pharma Research site 09
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Safed, Israel
- Mapi Pharma Research site 01
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Tel Aviv, Israel
- Mapi Pharma Research site 02
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Chisinau, Moldova, Republic of
- Mapi Pharma Research site 01
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Chisinau, Moldova, Republic of
- Mapi Pharma Research site 02
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Barnaul, Russian Federation
- Mapi Pharma Research site 29
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Bryansk, Russian Federation
- Mapi Pharma Research site 27
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Chelyabinsk, Russian Federation
- Mapi Pharma Research site 23
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Kazan, Russian Federation
- Mapi Pharma Research site 01
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Kemerovo, Russian Federation
- Mapi Pharma Research site 19
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Krasnodar, Russian Federation
- Mapi Pharma Research site 24
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Moscow, Russian Federation
- Mapi Pharma Research site 03
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Moscow, Russian Federation
- Mapi Pharma Research site 13
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Moscow, Russian Federation
- Mapi Pharma Research site 14
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Moscow, Russian Federation
- Mapi Pharma Research site 21
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Moscow, Russian Federation
- Mapi Pharma Research site 25
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Moscow, Russian Federation
- Mapi Pharma Research site 28
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Nizhniy Novgorod, Russian Federation
- Mapi Pharma Research site 10
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Nizhny Novgorod, Russian Federation
- Mapi Pharma Research site 02
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Nizhny Novgorod, Russian Federation
- Mapi Pharma Research site 07
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Novosibirsk, Russian Federation
- Mapi Pharma Research site 11
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Perm, Russian Federation
- Mapi Pharma Research site 06
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Pyatigorsk, Russian Federation
- Mapi Pharma Research site 22
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Rostov-Na-Donu, Russian Federation
- Mapi Pharma Research site 08
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Saint Petersburg, Russian Federation
- Mapi Pharma Research site 09
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Saint Petersburg, Russian Federation
- Mapi Pharma Research site 18
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Saint Petersburg, Russian Federation
- Mapi Pharma Research site 20
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Samara, Russian Federation
- Mapi Pharma Research site 05
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Saransk, Russian Federation
- Mapi Pharma Research site 26
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Smolensk, Russian Federation
- Mapi Pharma Research site 15
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Tyumen, Russian Federation
- Mapi Pharma Research site 16
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Ufa, Russian Federation
- Mapi Pharma Research site 04
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Ulyanovsk, Russian Federation
- Mapi Pharma Research site 17
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Cherkasy, Ukraine
- Mapi Pharma Research site 32
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Chernihiv, Ukraine
- Mapi Pharma Research site 06
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Chernivtsi, Ukraine
- Mapi Pharma Research site 11
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Dnipro, Ukraine
- Mapi Pharma Research site 24
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Dnipropetrovs'k, Ukraine
- Mapi Pharma Research site 03
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Dnipropetrovs'k, Ukraine
- Mapi Pharma Research site 04
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Ivano-Frankivs'k, Ukraine
- Mapi Pharma Research site 18
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Ivano-Frankivs'k, Ukraine
- Mapi Pharma Research site 26
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Ivano-Frankivs'k, Ukraine
- Mapi Pharma Research site 27
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Kharkiv, Ukraine
- Mapi Pharma Research site 09
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Kharkiv, Ukraine
- Mapi Pharma Research site 10
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Kherson, Ukraine
- Mapi Pharma Research site 08
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Kyiv, Ukraine
- Mapi Pharma Research site 21
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Kyiv, Ukraine
- Mapi Pharma Research site 25
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Kyiv, Ukraine
- Mapi Pharma Research site 28
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Kyiv, Ukraine
- Mapi Pharma Research site 29
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Luts'k, Ukraine
- Mapi Pharma Research site 17
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Lviv, Ukraine
- Mapi Pharma Research site 12
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Lviv, Ukraine
- Mapi Pharma Research site 13
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Lviv, Ukraine
- Mapi Pharma Research site 23
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Odesa, Ukraine
- Mapi Pharma Research site 05
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Poltava, Ukraine
- Mapi Pharma Research site 14
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Ternopil', Ukraine
- Mapi Pharma Research site 34
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Vinnitsa, Ukraine
- Mapi Pharma Research site 16
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Zaporizhzhya, Ukraine
- Mapi Pharma Research site 01
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Zaporizhzhya, Ukraine
- Mapi Pharma Research site 02
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Zaporizhzhya, Ukraine
- Mapi Pharma Research site 07
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Zaporizhzhya, Ukraine
- Mapi Pharma Research site 20
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Zhytomyr, Ukraine
- Mapi Pharma Research site 33
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Úzhgorod, Ukraine
- Mapi Pharma Research site 31
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Alabama
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Birmingham, Alabama, United States, 35209
- Mapi Pharma Research site 08
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Cullman, Alabama, United States, 35058
- Mapi Pharma Research site 11
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California
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Pasadena, California, United States, 91105
- Mapi Pharma Research site 15
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Colorado
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Denver, Colorado, United States, 80209
- Mapi Pharma Research site 14
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Mapi Pharma Research site 12
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Florida
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Homestead, Florida, United States, 33032
- Mapi Pharma Research site 17
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Miami, Florida, United States, 33136
- Mapi Pharma Research site 09
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Illinois
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Northbrook, Illinois, United States, 60062
- Mapi Pharma Research site 01
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Michigan
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Detroit, Michigan, United States, 48201
- Mapi Pharma Research site 02
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Ohio
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Westerville, Ohio, United States, 43081
- Mapi Pharma Research site 13
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Texas
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Round Rock, Texas, United States, 78681
- Mapi Pharma Research site 04
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
- 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.
- No systemic corticosteroid treatment or ACTH within one month prior to screening visit.
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.
- 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:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: GA Depot
Monthly IM injection
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Long acting intramuscular injection of glatiramer acetate, once every 4 weeks
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Placebo Comparator: Placebo
Monthly IM injection
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IM injection once every 4 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Annualized Relapse Rate (ARR)
Time Frame: 52 weeks
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Annualized Relapse Rate (ARR) will be derived from the total number of confirmed relapses.
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52 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Changes in brain MRI (number of T1 lesions)
Time Frame: 52 weeks
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Cumulative number of new enhancing lesions on T1-weighted images as compared to baseline.
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52 weeks
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Changes in brain MRI (number of T2 lesions)
Time Frame: 52 weeks
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Cumulative number of new or newly enlarging hyperintense T2 lesions as compared to baseline.
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52 weeks
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Hyperintense T2-lesion volume change
Time Frame: 52 weeks
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Change from baseline to Week 52 in hyperintense T2-lesion volume.
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52 weeks
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Enhancing T1-lesion volume change
Time Frame: 52 weeks
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Change from baseline to Week 52 in enhancing T1-lesion volume.
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52 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Laura Popper, MD, Mapi Pharma Ltd.
- Principal Investigator: Aaron E. Miller, Prof. MD, Mount Sinai School of Medicine, New York, US
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mapi GA Depot Phase III - 001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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