What is the mechanism of action of this treatment?

Multiple Sclerosis (MS) treatments often focus on modulating the immune system to reduce inflammation and prevent immune cells from attacking the nervous system. Monoclonal antibodies like alemtuzumab and natalizumab target specific immune cells or molecules to reduce their activity or prevent them from crossing the blood-brain barrier. Small molecules such as dimethyl fumarate work by activating the Nrf2 pathway, which provides neuroprotection and reduces oxidative stress. These treatments are crucial for MS patients as they help to slow disease progression, reduce relapse rates, and manage symptoms, thereby improving quality of life and long-term outcomes.

What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis, such as interferon beta-1a, fingolimod, natalizumab, and dimethyl fumarate, have a range of side effects. Interferon beta-1a can cause flu-like symptoms, injection site reactions, and elevated liver enzymes. Fingolimod is associated with headache, elevated liver enzymes, bradyarrhythmia, macular edema, and increased risk of infections. Natalizumab carries risks of progressive multifocal leukoencephalopathy (PML), liver injury, and infections. Dimethyl fumarate commonly causes flushing, gastrointestinal issues, and may also elevate liver enzymes. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

Several monoclonal antibodies and small molecules have been approved by the FDA for the treatment of Multiple Sclerosis (MS). Notable examples include natalizumab, which targets the alpha-4 integrin to prevent immune cells from crossing the blood-brain barrier, and alemtuzumab, which depletes circulating T and B lymphocytes. Ocrelizumab, another monoclonal antibody, targets CD20-positive B cells. Additionally, small molecules like fingolimod modulate sphingosine-1-phosphate receptors to retain lymphocytes in lymph nodes, reducing their migration to the central nervous system. These treatments aim to modulate the immune response and reduce disease activity in MS patients.

What other types of research exist?

Promising novel alternatives to SAR441344 for Multiple Sclerosis patients include: 1) Alemtuzumab, a monoclonal antibody against CD52, effective for highly active relapsing-remitting MS (RRMS). 2) Natalizumab, an anti-α4 integrin monoclonal antibody, shown to be effective in RRMS. 3) Ocrelizumab, a monoclonal antibody targeting CD20-positive B cells, approved for both RRMS and primary progressive MS. 4) Ofatumumab, another anti-CD20 monoclonal antibody, effective in reducing relapse rates in MS. These therapies have demonstrated efficacy in clinical trials and are viable options for MS treatment.

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Monoclonal Antibodies

Frexalimab for Multiple Sclerosis

Phase 2

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must have at least 1 documented relapse within the previous year, or ≥2 documented relapses within the previous 2 years, or ≥1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months and prior to screening

Body weight within 45 to 120 kg (inclusive) and body mass index (BMI) within the range 18.0 to 35.0 kg/m2 (inclusive) at Screening

Must not have

History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment

Participant has an EDSS score >5.5 at the first screening visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until week 316

Summary

This trial is testing a new drug called SAR441344 to see if it can reduce the number of new active brain lesions in patients. The study will also check how well the drug works overall, its safety, and how it behaves in the body. Patients will participate for several years, including screening, treatment, and follow-up periods.

Who is the study for?

This trial is for adults aged 18-55 with relapsing multiple sclerosis (RMS), who've had at least one relapse in the past year or a new brain lesion recently. They must weigh between 45 to 120 kg, have a BMI of 18.0 to 35.0, and agree to use contraception according to local guidelines.

What is being tested?

The study tests SAR441344's effectiveness on reducing new active brain lesions in RMS patients, compared against placebos. It involves intravenous (IV) and subcutaneous (SC) injections, along with MRI scans using contrast agents.

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to SAR441344 being a humanized monoclonal antibody; however, specific side effects are not listed but will be monitored for safety and tolerability.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had at least one relapse in the past year or a recent MRI showing active brain lesions.

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My weight is between 45 and 120 kg, and my BMI is between 18.0 and 35.0.

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I am between 18 and 55 years old.

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I have been diagnosed with RMS according to the 2017 McDonald criteria.

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My weight is between 45 to 120 kg and my BMI is between 18.0 to 35.0.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history or risk of blood clots, heart attack, stroke, or need blood thinner medication.

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My disability due to MS is severe, needing help to walk.

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I have been diagnosed with primary progressive or non-relapsing secondary progressive MS.

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I have tested positive for Hepatitis B recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until week 316

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until week 316

This trial's timeline: 3 weeks for screening, Varies for treatment, and until week 316 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of new Gadolinium (Gd)-enhancing T1-hyperintense (GdE T1) lesions

Secondary study objectives

Adverse events (AEs) and serious adverse events (SAEs)

Antidrug antibodies (ADA)

Number of new or enlarging T2 lesions

+5 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Subcutaneous (SC) SAR441344Experimental Treatment2 Interventions

SAR441344 SC

Group II: Intravenous (IV) SAR441344Experimental Treatment2 Interventions

SAR441344 IV

Group III: IV PlaceboPlacebo Group2 Interventions

Placebo IV

Group IV: SC PlaceboPlacebo Group2 Interventions

Placebo SC

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Sclerosis (MS) treatments often focus on modulating the immune system to reduce inflammation and prevent immune cells from attacking the nervous system. Monoclonal antibodies like alemtuzumab and natalizumab target specific immune cells or molecules to reduce their activity or prevent them from crossing the blood-brain barrier. Small molecules such as dimethyl fumarate work by activating the Nrf2 pathway, which provides neuroprotection and reduces oxidative stress. These treatments are crucial for MS patients as they help to slow disease progression, reduce relapse rates, and manage symptoms, thereby improving quality of life and long-term outcomes.

Construction of miRNA-regulated drug-pathway network to screen drug repurposing candidates for multiple sclerosis.Disease-modifying treatments for progressive multiple sclerosis.