Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS
Primary Purpose
Multiple Sclerosis
Status
Active
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
GA Depot 80 mg
GA Depot 40 mg
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Glatiramer acetate, Copaxone®, Multiple sclerosis, Relapsing remitting multiple sclerosis, RRMS, GA Depot, Monthly injection
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Barzilai Medical Center
- Rambam Medical Center
- TASMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
GA Depot 80mg
GA Depot 40mg
Arm Description
Monthly IM injection
Monthly IM injection
Outcomes
Primary Outcome Measures
Safety / Adverse events
Number of patients experiencing adverse events and assessments of localized skin reactions at injection sites.
Secondary Outcome Measures
Efficacy/Change in Relapse Rate
Relapse rate detected during the study compared to relapse rate observed in the 12 months prior to study start.
Efficacy/Changes in brain MRI
Changes from baseline to end of treatment visit in the number of enhancing lesions and new lesions images of brain MRI
Efficacy/Changes in EDSS
Change from baseline to end of treatment visit of Expanded Disability Status Scale (EDSS) score.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02212886
Brief Title
Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS
Official Title
A Prospective 1-year, Open-label, Two Arms, Multicenter, Phase IIa Study to Assess Safety, Tolerability and Efficacy of Once a Month Long-acting Intramuscular Injection of 80 or 40 mg Glatiramer Acetate (GA Depot) in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2014 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
November 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mapi Pharma Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
25 Subjects with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who are treated with daily or thrice weekly subcutaneous injections of 20 mg or 40 mg respectively of GA (Copaxone®) during the previous 12 months
Study product is GA long-acting injection (GA Depot) which is a combination of extended-release microspheres for injection and diluent (water for injection) for parenteral use. GA Depot will be administered intramuscularly (IM).
The study duration for an individual subject in the core study will be 60 weeks, consisting of 4 weeks of screening evaluation (weeks -4 to 0), followed by a 52-week open-label treatment period, and a 4 weeks follow up period: through a total of 17 visits.
For both arms, subjects who completed 13 injections and who consented (by signing an informed consent) are able to enter the optional 8 years extension period. During the extension period subjects will receive 40 mg of GA Depot IM once every 4 weeks.
Physical, vital signs and safety assessment - will be performed at each visit during the whole study. Physical examination will be performed quarterly during the extension period.
MRI at visit 1 (screenings), at week 24, week 52 (end of core study) and every 6 months during the extension period.
Neurological and safety laboratory tests at screening visit, on visits in weeks 4, 12, 24, 36, 52 (end of core study) and every 6 months during the extension period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Glatiramer acetate, Copaxone®, Multiple sclerosis, Relapsing remitting multiple sclerosis, RRMS, GA Depot, Monthly injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GA Depot 80mg
Arm Type
Experimental
Arm Description
Monthly IM injection
Arm Title
GA Depot 40mg
Arm Type
Experimental
Arm Description
Monthly IM injection
Intervention Type
Drug
Intervention Name(s)
GA Depot 80 mg
Other Intervention Name(s)
Microspheres containing GA
Intervention Description
Recruitment completed
Intervention Type
Drug
Intervention Name(s)
GA Depot 40 mg
Other Intervention Name(s)
Microspheres containing GA
Intervention Description
Recruitment completed
Primary Outcome Measure Information:
Title
Safety / Adverse events
Description
Number of patients experiencing adverse events and assessments of localized skin reactions at injection sites.
Time Frame
During the study (1 year treatment)
Secondary Outcome Measure Information:
Title
Efficacy/Change in Relapse Rate
Description
Relapse rate detected during the study compared to relapse rate observed in the 12 months prior to study start.
Time Frame
During the study (1 year treatment)
Title
Efficacy/Changes in brain MRI
Description
Changes from baseline to end of treatment visit in the number of enhancing lesions and new lesions images of brain MRI
Time Frame
During the study (1 year treatment)
Title
Efficacy/Changes in EDSS
Description
Change from baseline to end of treatment visit of Expanded Disability Status Scale (EDSS) score.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shlomo Flechter, M.D
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barzilai Medical Center
City
Ashkelon
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
TASMC
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
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Safety, Tolerability and Efficacy of Monthly Long-acting IM Injection of 80 or 40 mg GA Depot in Subjects With RRMS
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