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
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
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
8. Subjects must have experienced at least one of the following:
i. One documented relapse in the 12 months prior to screening. ii. 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
visit and use an adequate contraceptive method throughout the study.
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.
4. Previous use of Natalizumab or any anti-B cell agent within 9 months prior to
5. Previous use of Fingolimod or Dimethyl 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
6. Previous use of Teriflunomide within 12 months if no accelerated elimination procedure
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. 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. A history of positive VDRL or positive testing for 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
24. Subjects with uncontrolled diabetes.
25. Subjects with clotting disorders or receiving treatment with anticoagulants.
- Mapi Pharma Research site 15, Pasadena, California, United States, 91105