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

NCT03362294 | Terminated Phase 2 DMC

• 1 other identifier: PPMS-GA Depot 002
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 7

Brief Summary

This is a phase IIa study with GA Depot in subjects with Primary Progressive MS. GA Depot will be administered intramuscularly (IM), once every four weeks for 148 weeks. The purpose of this study is to assess the safety and efficacy of GA Depot to slow the accumulation of disability progression in subjects with Primary Progressive MS.

Conditions

Primary Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Safety (Adverse Events and Injection Site Reactions)

  Assessment of Adverse events (AEs) \& Injection Sites Reactions (ISRs)

  152 weeks

Secondary Outcomes (3)

• Efficacy (Confirmed Disease Progression)

  148 weeks

• Efficacy (Whole brain volume change)

  148 weeks

• Efficacy (Cortical volume change)

  148 weeks

Study Arms (2)

GA Depot 40mg once monthly

EXPERIMENTAL

Monthly IM injection

Drug: GA Depot 40mg once monthly

GA Depot 25mg once monthly

EXPERIMENTAL

Monthly IM injection

Drug: GA Depot 25mg once monthly

Interventions

GA Depot 40mg once monthly DRUG

Once-a-month long-acting intramuscular injection of 40mg Glatiramer Acetate (GA Depot)

GA Depot 40mg once monthly

GA Depot 25mg once monthly DRUG

Once-a-month long-acting intramuscular injection of 25mg Glatiramer Acetate (GA Depot)

GA Depot 25mg once monthly

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects diagnosed with PPMS; Diagnosis of PPMS consistent with the McDonald Criteria (revisions of 2010).
• Age between 18 and 65 years (inclusive).
• 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.
• EDSS ≥2 and ≤ 6.5 (Pyramidal or Cerebellar FS ≥ 2).
• 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).
• Women of child bearing potential must have a negative urine pregnancy test at screening and use an adequate contraceptive method throughout the study.
• Ability to provide written informed consent.

You may not qualify if:

• Subjects with RRMS, SPMS, or PRMS.
• Subjects with a documented history of clinical relapse events.
• 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.
• Contraindications or inability to successfully undergo magnetic resonance imaging (MRI) scanning.
• 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.
• Severe anemia (hemoglobin \<10 g/dL).
• Abnormal renal function (serum creatinine \>1.5xULN or creatinine clearance \<30 ml/min).
• Abnormal liver function (transaminases \>2xULN).
• Pregnant or breast-feeding women.
• Treatment with any kind of steroids during the last month prior to screening visit.
• 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).
• Known or suspected history of drug or alcohol abuse.
• Known as positive for HIV, hepatitis, VDRL, or tuberculosis.
• 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.
• Previous treatment with B-cell-targeting therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab or ofatumumab) within 6 months prior to screening visit.

Sponsors & Collaborators

• Mapi Pharma Ltd.: lead

Study Sites (7)

Mapi Pharma Research site 09

Haifa, Israel

Location

Mapi Pharma Research site 07

Jerusalem, Israel

Location

Mapi Pharma Research site 08

Petah Tikva, Israel

Location

Mapi Pharma Research site 06

Rehovot, Israel

Location

Mapi Pharma Research site 01

Tel Aviv, Israel

Location

Mapi Pharma Research site 20

Chisinau, Moldova

Location

Mapi Pharma Research site 22

Chisinau, Moldova

Location

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnon Karni, MD

  Coordinating PI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The first 20 subjects are allocated to the 40mg arm and the last 10 subjects are allocated to the 25mg.

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: December 5, 2017
• Study Start: December 11, 2017
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

MO (2); IL (5)