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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04121221
Other study ID # Mapi GA Depot Phase III - 001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 19, 2019
Est. completion date June 13, 2023

Study information

Verified date November 2023
Source Mapi Pharma Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 1016
Est. completion date June 13, 2023
Est. primary completion date June 13, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 IFNß 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GA Depot
Long acting intramuscular injection of glatiramer acetate, once every 4 weeks
Other:
Placebo
IM injection once every 4 weeks

Locations

Country Name City State
Belarus Mapi Pharma Research site 02 Gomel
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
Bosnia and Herzegovina Mapi Pharma Research site 04 Banja Luka
Bosnia and Herzegovina Mapi Pharma Research site 06 Bihac
Bosnia and Herzegovina Mapi Pharma Research site 01 Sarajevo
Bosnia and Herzegovina Mapi Pharma Research site 03 Tuzla
Bulgaria 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
Estonia Mapi Pharma Research site 01 Tallinn
Georgia 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
Israel Mapi Pharma Research site 01 Safed
Israel Mapi Pharma Research site 02 Tel Aviv
Moldova, Republic of Mapi Pharma Research site 01 Chisinau
Moldova, Republic of Mapi Pharma Research site 02 Chisinau
Russian Federation Mapi Pharma Research site 29 Barnaul
Russian Federation Mapi Pharma Research site 27 Bryansk
Russian Federation Mapi Pharma Research site 23 Chelyabinsk
Russian Federation Mapi Pharma Research site 01 Kazan
Russian Federation Mapi Pharma Research site 19 Kemerovo
Russian Federation Mapi Pharma Research site 24 Krasnodar
Russian Federation Mapi Pharma Research site 03 Moscow
Russian Federation Mapi Pharma Research site 13 Moscow
Russian Federation Mapi Pharma Research site 14 Moscow
Russian Federation Mapi Pharma Research site 21 Moscow
Russian Federation Mapi Pharma Research site 25 Moscow
Russian Federation Mapi Pharma Research site 28 Moscow
Russian Federation Mapi Pharma Research site 10 Nizhniy Novgorod
Russian Federation Mapi Pharma Research site 02 Nizhny Novgorod
Russian Federation Mapi Pharma Research site 07 Nizhny Novgorod
Russian Federation Mapi Pharma Research site 11 Novosibirsk
Russian Federation Mapi Pharma Research site 06 Perm
Russian Federation Mapi Pharma Research site 22 Pyatigorsk
Russian Federation Mapi Pharma Research site 08 Rostov-Na-Donu
Russian Federation Mapi Pharma Research site 09 Saint Petersburg
Russian Federation Mapi Pharma Research site 18 Saint Petersburg
Russian Federation Mapi Pharma Research site 20 Saint Petersburg
Russian Federation Mapi Pharma Research site 05 Samara
Russian Federation Mapi Pharma Research site 26 Saransk
Russian Federation Mapi Pharma Research site 15 Smolensk
Russian Federation Mapi Pharma Research site 16 Tyumen
Russian Federation Mapi Pharma Research site 04 Ufa
Russian Federation Mapi Pharma Research site 17 Ulyanovsk
Ukraine 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 24 Dnipro
Ukraine Mapi Pharma Research site 03 Dnipropetrovs'k
Ukraine Mapi Pharma Research site 04 Dnipropetrovs'k
Ukraine Mapi Pharma Research site 18 Ivano-Frankivs'k
Ukraine Mapi Pharma Research site 26 Ivano-Frankivs'k
Ukraine Mapi Pharma Research site 27 Ivano-Frankivs'k
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 Luts'k
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 Úzhgorod
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
United States Mapi Pharma Research site 08 Birmingham Alabama
United States Mapi Pharma Research site 11 Cullman Alabama
United States Mapi Pharma Research site 14 Denver Colorado
United States Mapi Pharma Research site 02 Detroit Michigan
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 15 Pasadena California
United States Mapi Pharma Research site 04 Round Rock Texas
United States Mapi Pharma Research site 12 Washington District of Columbia
United States Mapi Pharma Research site 13 Westerville Ohio

Sponsors (1)

Lead Sponsor Collaborator
Mapi Pharma Ltd.

Countries where clinical trial is conducted

United States,  Belarus,  Bosnia and Herzegovina,  Bulgaria,  Estonia,  Georgia,  Israel,  Moldova, Republic of,  Russian Federation,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Annualized Relapse Rate (ARR) Annualized Relapse Rate (ARR) will be derived from the total number of confirmed relapses. 52 weeks
Secondary Changes in brain MRI (number of T1 lesions) Cumulative number of new enhancing lesions on T1-weighted images as compared to baseline. 52 weeks
Secondary Changes in brain MRI (number of T2 lesions) Cumulative number of new or newly enlarging hyperintense T2 lesions as compared to baseline. 52 weeks
Secondary Hyperintense T2-lesion volume change Change from baseline to Week 52 in hyperintense T2-lesion volume. 52 weeks
Secondary Enhancing T1-lesion volume change Change from baseline to Week 52 in enhancing T1-lesion volume. 52 weeks
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