Primary Progressive Multiple SclerosisPhase 2NCT03362294
Safety and Efficacy of Monthly Long-acting IM Injection of 25mg or 40 mg GA Depot in Subjects With PPMS
A Phase 2 study testing GA Depot 40mg once monthly and GA Depot 25mg once monthly in people with Primary Progressive Multiple Sclerosis, run by Mapi Pharma Ltd. at 7 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Progressive Multiple Sclerosis
- What is being tested?
- GA Depot 40mg once monthly and GA Depot 25mg once monthly
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 11 Dec 2017to 20 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Israel5 sites
Mapi Pharma Research site 09
Haifa
Mapi Pharma Research site 07
Jerusalem
Mapi Pharma Research site 08
Petah Tikva
Mapi Pharma Research site 06
Rehovot
Mapi Pharma Research site 01
Tel Aviv
Moldova2 sites
Mapi Pharma Research site 20
Chisinau
Mapi Pharma Research site 22
Chisinau
About this study
Official 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)
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.
Read the 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.
- Conditions
- Primary Progressive Multiple Sclerosis
- Being tested
- GA Depot 40mg once monthly, GA Depot 25mg once monthly
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GA Depot 40mg once monthlyDrug
Once-a-month long-acting intramuscular injection of 40mg Glatiramer Acetate (GA Depot)
GA Depot 25mg once monthlyDrug
Once-a-month long-acting intramuscular injection of 25mg Glatiramer Acetate (GA Depot)
| Study group | Role | What they receive |
|---|---|---|
| GA Depot 40mg once monthly | Experimental | Monthly IM injection Receives: Drug: GA Depot 40mg once monthly |
| GA Depot 25mg once monthly | Experimental | Monthly IM injection Receives: Drug: GA Depot 25mg once monthly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (Adverse Events and Injection Site Reactions)
Assessment of Adverse events (AEs) \& Injection Sites Reactions (ISRs)
Measured: 152 weeks
Secondary outcomes (3)
Efficacy (Confirmed Disease Progression)
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.
Measured: 148 weeks
Efficacy (Whole brain volume change)
MRI assessment of percent of whole brain volume change.
Measured: 148 weeks
Efficacy (Cortical volume change)
MRI assessment of percent of cortical volume change.
Measured: 148 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start11 Dec 2017
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Why it stopped: The study was terminated early as part of a global realignment of Sponsor's clinical development programs. This decision is not related to any safety concerns regarding the IP.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Progressive Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The first 20 subjects are allocated to the 40mg arm and the last 10 subjects are allocated to the 25mg.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mapi Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnon Karni, MD, Principal investigator, Coordinating PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362294
- Sponsor's protocol ID
- PPMS-GA Depot 002
- Status last verified
- Apr 2026
- First submitted
- 15 Nov 2017
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT03362294
- Acronym / sponsor ID
- PPMS-GA Depot 002
- Conditions
- Primary Progressive Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early as part of a global realignment of Sponsor's clinical development programs. This decision is not related to any safety concerns regarding the IP.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mapi Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first 20 subjects are allocated to the 40mg arm and the last 10 subjects are allocated to the 25mg.
| Arm | Type | Receives |
|---|---|---|
| GA Depot 40mg once monthly | Experimental | Drug: GA Depot 40mg once monthlyMonthly IM injection |
| GA Depot 25mg once monthly | Experimental | Drug: GA Depot 25mg once monthlyMonthly IM injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GA Depot 40mg once monthlyOnce-a-month long-acting intramuscular injection of 40mg Glatiramer Acetate (GA Depot) | Drug | GA Depot 40mg once monthly |
| GA Depot 25mg once monthlyOnce-a-month long-acting intramuscular injection of 25mg Glatiramer Acetate (GA Depot) | Drug | GA Depot 25mg once monthly |
Primary outcome
Safety (Adverse Events and Injection Site Reactions)
Time frame: 152 weeks
Assessment of Adverse events (AEs) \& Injection Sites Reactions (ISRs)
3 secondary outcomes
Efficacy (Confirmed Disease Progression)
Time frame: 148 weeks
Efficacy (Whole brain volume change)
Time frame: 148 weeks
Efficacy (Cortical volume change)
Time frame: 148 weeks
Results and safety
The study was stopped early (reason given: The study was terminated early as part of a global realignment of Sponsor's clinical development programs. This decision is not related to any safety concerns regarding the IP.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnon Karni, MD principal investigator
Coordinating PI
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GA Depot 40mg once monthly and GA Depot 25mg once monthly in people with Primary Progressive Multiple Sclerosis, run by Mapi Pharma Ltd. at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Israel, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated early as part of a global realignment of Sponsor's clinical development programs. This decision is not related to any safety concerns regarding the IP.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (Adverse Events and Injection Site Reactions) (time frame: 152 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.