Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS

• Register: ClinicalTrials.gov
• Last refreshed on: 27 November 2023
• Main ID: NCT03362294
• Date of registration: 15/11/2017
• Prospective Registration: Yes
• Primary sponsor: Mapi Pharma Ltd.
• Public title: Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS
• Scientific title: A Prospective, Multicenter, Two Arms, Open Label, Phase IIa Study to Assess the Safety and Efficacy of Once-a-month Long-acting Intramuscular Injection of 25 mg or 40mg Glatiramer Acetate (GA Depot) in Subjects With Primary Progressive Multiple Sclerosis (PPMS)
• Date of first enrolment: December 11, 2017
• Target sample size: 30
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03362294
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Israel, Moldova, Republic of

Contacts

• Name: Arnon Karni, MD
• Affiliation: Coordinating PI

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female subjects diagnosed with PPMS; Diagnosis of PPMS consistent with the
McDonald Criteria (revisions of 2010).

2. Age between 18 and 65 years (inclusive).

3. Subjects diagnosed with PPMS for at least 1 year and with signs of disease progression
in the year prior to screening, in a rate of = 1 point increase / year in the EDSS
score for EDSS between 2-5 and a rate of =0.5 point increase / year in the EDSS scores
> 5.

4. EDSS =2 and = 6.5 (Pyramidal or Cerebellar FS = 2).

5. Documented history or the presence at screening of > 1 oligoclonal band (OCB) if
quantitative testing was done, or OCB+ if not quantitative testing done and/or
positive IgG index in the cerebrospinal fluid (CSF).

6. Women of child bearing potential must have a negative urine pregnancy test at
screening and use an adequate contraceptive method throughout the study.

7. Ability to provide written informed consent.

Exclusion Criteria:

1. Subjects with RRMS, SPMS, or PRMS.

2. Subjects with a documented history of clinical relapse events.

3. Any relevant medical, surgical, or psychiatric condition, laboratory value, or
concomitant medication which, in the opinion of the investigator, makes the subject
unsuitable for study entry or potentially unable to complete all aspects of the study.

4. Contraindications or inability to successfully undergo magnetic resonance imaging
(MRI) scanning.

5. Subjects diagnosed with any other than MS systemic autoimmune disease that may impact
the CNS with MS like lesions such as Sarcoidosis, Sjögren's syndrome, Systemic Lupus
Erythematosus (SLE), Lyme disease, APLA syndrome, etc.. Subjects with stable
local/organ autoimmune disease such as psoriasis, Cutaneous Lupus erythematosus,
thyroiditis (Hashimoto, grave) etc. may be considered eligible upon the PI's
discretion.

6. Severe anemia (hemoglobin <10 g/dL).

7. Abnormal renal function (serum creatinine >1.5xULN or creatinine clearance <30
ml/min).

8. Abnormal liver function (transaminases >2xULN).

9. Pregnant or breast-feeding women.

10. Treatment with any kind of steroids during the last month prior to screening visit.

11. History of any anaphylactic reaction and/or serious allergic reaction following a
vaccination, a known hypersensitivity to any component of the study drug, e.g.
glatiramer acetate (GA), polylactic-co-glycolic acid (PLGA), polyvinyl alcohol (PVA).

12. Known or suspected history of drug or alcohol abuse.

13. Known as positive for HIV, hepatitis, VDRL, or tuberculosis.

14. Active malignant disease of any kind. However, a patient, who had a malignant disease
in the past, was treated and is currently disease - free for at least 7 years, may be
considered eligible, upon the PI and sponsor's discretion.

15. Previous treatment with B-cell-targeting therapies (e.g. rituximab, ocrelizumab,
atacicept, belimumab or ofatumumab) within 6 months prior to screening visit.

16. Previous treatment with cladribine within 2 years prior to screening visit

17. Previous treatment with azathioprine, mitoxantrone or methotrexate within 6 months
prior to screening visit.

18. Previous treatment with lymphocyte-trafficking modifiers (e.g. natalizumab,
fingolimod) within 6 months prior to screening visit. Subjects should have a total
lymphocyte count within normal range.

19. Previous treatment with beta interferons, intravenous immunoglobulin, plasmapheresis
within 2 months prior to screening visit.

20. Previous treatment with any glatiramer acetate therapy within 3 months prior to
screening visit.

21. Uncontrolled diabetes.

22. Participation in an investigational study drug within 30 days prior to study entry.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Progressive Multiple Sclerosis

Intervention(s)

Drug: GA Depot 40mg once monthly

Drug: GA Depot 25mg once monthly

Primary Outcome(s)

Safety (Adverse Events and Injection Site Reactions) [Time Frame: 152 weeks]

Secondary Outcome(s)

Efficacy (Whole brain volume change) [Time Frame: 148 weeks]

Efficacy (Cortical volume change) [Time Frame: 148 weeks]

Efficacy (Confirmed Disease Progression) [Time Frame: 148 weeks]

Secondary ID(s)

PPMS-GA Depot 002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors