- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03362294
Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS
November 14, 2023 updated by: Mapi Pharma Ltd.
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)
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
- 30 Subjects with a diagnosis of primary progressive multiple sclerosis (PPMS) who are not treated for PPMS at study entry (except for symptoms relief).
- 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 156 weeks, consisting of 4 weeks of screening evaluation (weeks -4 to 0), followed by a 148-week open-label treatment period, and a 4 weeks follow up period: through a total of 41 visits.
- Vital signs and safety assessment will be performed at each visit during the study.
- Physical examination will be performed at screening, baseline, 1 week after the second GA Depot treatment, 3 months after first GA Depot treatment and every 3 months thereafter. Last physical examination will be performed at FU visit.
- MRI will be performed at screenings and every 6 months thereafter until the end of the treatment period .
- Safety laboratory tests will be performed at screening, baseline, 1 month after first treatment, and every 3 months thereafter.
- Neurological assessment will be performed at screening, baseline, 3 months, and then every 3 months until end of treatment.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Haifa, Israel
- Mapi Pharma Research site 09
-
Jerusalem, Israel
- Mapi Pharma Research site 07
-
Petah tikva, Israel
- Mapi Pharma Research site 08
-
Rehovot, Israel
- Mapi Pharma Research site 06
-
Tel Aviv, Israel
- Mapi Pharma Research site 01
-
-
-
-
-
Chisinau, Moldova, Republic of
- Mapi Pharma Research site 20
-
Chisinau, Moldova, Republic of
- Mapi Pharma Research site 22
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Previous treatment with cladribine within 2 years prior to screening visit
- Previous treatment with azathioprine, mitoxantrone or methotrexate within 6 months prior to screening visit.
- 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.
- Previous treatment with beta interferons, intravenous immunoglobulin, plasmapheresis within 2 months prior to screening visit.
- Previous treatment with any glatiramer acetate therapy within 3 months prior to screening visit.
- Uncontrolled diabetes.
- Participation in an investigational study drug within 30 days prior to study entry.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GA Depot 40mg once monthly
Monthly IM injection
|
Once-a-month long-acting intramuscular injection of 40mg Glatiramer Acetate (GA Depot)
|
Experimental: GA Depot 25mg once monthly
Monthly IM injection
|
Once-a-month long-acting intramuscular injection of 25mg Glatiramer Acetate (GA Depot)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety (Adverse Events and Injection Site Reactions)
Time Frame: 152 weeks
|
Assessment of Adverse events (AEs) & Injection Sites Reactions (ISRs)
|
152 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy (Confirmed Disease Progression)
Time Frame: 148 weeks
|
Time to onset of Confirmed Disease Progression (CDP) assessed by Expanded Disability Status Scale (EDSS).
EDSS is a method of quantifying disability in people with MS.
The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
|
148 weeks
|
Efficacy (Whole brain volume change)
Time Frame: 148 weeks
|
MRI assessment of percent of whole brain volume change.
|
148 weeks
|
Efficacy (Cortical volume change)
Time Frame: 148 weeks
|
MRI assessment of percent of cortical volume change.
|
148 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Arnon Karni, MD, Coordinating PI
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 11, 2017
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
November 15, 2017
First Submitted That Met QC Criteria
December 3, 2017
First Posted (Actual)
December 5, 2017
Study Record Updates
Last Update Posted (Actual)
November 15, 2023
Last Update Submitted That Met QC Criteria
November 14, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPMS-GA Depot 002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary Progressive Multiple Sclerosis
-
University of MinnesotaMallinckrodtTerminatedPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
Rebecca SpainCompletedComparing Tolerability and Absorption of Racemic and R-lipoic Acid in Progressive Multiple SclerosisProgressive Multiple Sclerosis | Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
Brigham and Women's HospitalMassachusetts General HospitalRecruitingMultiple Sclerosis | Relapsing Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Johns Hopkins UniversityCompletedPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkUniversity of Copenhagen; Biogen; Copenhagen University Hospital, Hvidovre; Signifikans...CompletedPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
University of California, Los AngelesRecruitingPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
University College DublinCompletedPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisIreland
-
Innate ImmunotherapeuticsNational Multiple Sclerosis Society; Primorus Clinical TrialsCompletedPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisNew Zealand
Clinical Trials on GA Depot 40mg once monthly
-
Mapi Pharma Ltd.Active, not recruiting
-
Mapi Pharma Ltd.CompletedMultiple Sclerosis, Relapsing-RemittingUnited States, Belarus, Bosnia and Herzegovina, Bulgaria, Estonia, Georgia, Israel, Moldova, Republic of, Russian Federation, Ukraine
-
AstraZenecaEli Lilly and CompanyCompletedType 2 DiabetesUnited States
-
Neurotrope Bioscience, Inc.National Institutes of Health (NIH); National Institute on Aging (NIA)Completed
-
Auxilius Pharma sp.z.o.o.Active, not recruitingChronic Stable AnginaPortugal
-
Otsuka Pharmaceutical Co., Ltd.Completed
-
Hospital do CoracaoMinistry of Health, BrazilCompleted
-
University of PittsburghTerminatedAnesthesia, Local | Pain, Acute | Neuropathic Pain | Thoracic Injuries | Neuromuscular Blockade | Rib FracturesUnited States
-
Tel-Aviv Sourasky Medical CenterTel Aviv Medical CenterCompletedCoronary Heart Disease | GI BleedingIsrael
-
University at BuffaloKaleida HealthTerminatedObesity | Insulin Resistance | Type 2 DiabetesUnited States