Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS

NCT02212886 | Completed Phase 1

• 1 other identifier: MI GA Depot - 001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

• This is a phase IIa study in which GA Depot 80 or 40mg is administered as an IM injection to subjects with RRMS at 4 week intervals for 52 weeks of treatment.
• The purpose of the study is to assess safety, tolerability, and efficacy of a monthly long-acting IM injection of 80 or 40mg GA Depot in subjects with RRMS. The study will include subjects switching from daily or thrice weekly administration of 20 mg or 40mg respectively of glatiramer acetate (GA, i.e., Copaxone®) injection

Conditions

Multiple Sclerosis

Keywords

Glatiramer acetate; Copaxone®; Multiple sclerosis; Relapsing remitting multiple sclerosis; RRMS; GA Depot; Monthly injection

Outcome Measures

Primary Outcomes (1)

• Safety / Adverse events

  Number of patients experiencing adverse events and assessments of localized skin reactions at injection sites.

  During the study (1 year treatment)

Secondary Outcomes (3)

• Efficacy/Change in Relapse Rate

  During the study (1 year treatment)

• Efficacy/Changes in brain MRI

  During the study (1 year treatment)

• Efficacy/Changes in EDSS

  1 year

Study Arms (2)

GA Depot 80mg

EXPERIMENTAL

Monthly IM injection

Drug: GA Depot 80 mg

GA Depot 40mg

EXPERIMENTAL

Monthly IM injection

Drug: GA Depot 40 mg

Interventions

GA Depot 80 mg DRUG

Recruitment completed

Also known as: Microspheres containing GA

GA Depot 80mg

GA Depot 40 mg DRUG

Recruitment completed

Also known as: Microspheres containing GA

GA Depot 40mg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects with a diagnosis of RRMS.
• Diagnosis of multiple sclerosis (MS) consistent with the McDonald Criteria (revisions of 2010).
• Treatment with 20 mg or 40 mg of GA (Copaxone®) during the previous 12 months with ongoing treatment at the Screening Visit.
• Normal renal function.
• Normal liver function.
• Normal hemoglobin concentration.
• Absence of any clinically significant medical, psychiatric or laboratory abnormalities.
• Ability to provide written informed consent.

You may not qualify if:

• 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.
• Concomitant Autoimmune disease.
• Severe anemia (hemoglobin \< 10 g/dL).
• Abnormal renal function (serum creatinine \> 1.5xULN).
• Abnormal liver function (transaminases \>2xULN).
• Pregnant or breast-feeding women.
• Women capable of child bearing must have a negative urine pregnancy test at screening visit and use an adequate contraceptive method throughout the study. Women who are surgically sterile (hysterectomy or tubal ligation) or whose last menstruation was 12 months or more prior to the Screening Visit are considered to be of non-child-bearing potential. Acceptable forms of contraception include oral, implanted, or injected contraceptives; intrauterine devices in place for at least 3 months; estrogen patch; and adequate barrier methods in conjunction with spermicide. Abstinence is considered an acceptable contraceptive regimen.
• History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study drug, e.g. GA, polylactic-co-glycolic acid (PLGA), polyvinyl alcohol (PVA).
• Known or suspected history of drug or alcohol abuse.
• Positive test for HIV, hepatitis, venereal disease research laboratory test (VDRL), or tuberculosis.
• Participation in an investigational drug study within 30 days prior to start of this study.
• Active malignant disease of any kind. However, a patient, who has had a malignant disease in the past, was treated and is currently disease - free for at least 5 years, may be considered to be enrolled in the study. In this case the sponsor medical expert approval is required.
• Treatment with any kind of steroids during the last 30 days.
• Confirmed relapse during the last 30 days.

Sponsors & Collaborators

• Mapi Pharma Ltd.: lead

Study Sites (3)

Barzilai Medical Center

Ashkelon, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

TASMC

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Shlomo Flechter, M.D

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2014
• First Posted: August 8, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: November 20, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-12

Locations

IL (3)