What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis that target neuroinflammation or neuroprotection include fingolimod, glatiramer acetate, and dimethyl fumarate. Fingolimod is associated with side effects such as headache, elevated liver enzymes, bradyarrhythmia, macular edema, and increased risk of infections. Glatiramer acetate can cause local injection site reactions and, less commonly, systemic reactions like chest pain and palpitations. Dimethyl fumarate's side effects include flushing, gastrointestinal issues, and a potential decrease in lymphocyte counts, which can increase infection risk.

What prior FDA approvals exist?

Several drugs have been FDA-approved for the treatment of Multiple Sclerosis, focusing on neuroinflammation and neuroprotection. Dimethyl fumarate (BG-12) reduces relapse rates and new brain lesions by modulating the immune response. Glatiramer acetate mimics myelin basic protein, inducing specific T helper 2 cells that suppress inflammation. Alemtuzumab targets CD52 on immune cells, reducing relapse rates but with a risk of serious infections and autoimmune disorders. These treatments aim to manage MS by modulating immune activity and protecting neural structures.

What other types of research exist?

Promising, novel alternatives to SAR443820 for Multiple Sclerosis patients include Dimethyl Fumarate (Tecfidera®), which has anti-inflammatory and cytoprotective properties, and FTY720 (Fingolimod), which modulates sphingosine 1-phosphate receptor 1 (S1P1) on astrocytes to provide neuroprotection. Both have shown efficacy in clinical trials for relapsing forms of MS.

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Small Molecule

SAR443820 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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 96

Summary

This trial tests a new pill called SAR443820 in adults aged 18-60 with multiple sclerosis. The goal is to see if the pill can reduce nerve damage by lowering a specific protein in the blood. The study will also check if the pill is safe and well-tolerated.

Who is the study for?

Adults aged 18-60 with Multiple Sclerosis (RRMS, SPMS, or PPMS) can join this trial. They must be stable on approved treatments for at least 3 months or untreated, have an EDSS score up to 26, weigh at least 45 kg with a BMI of at least 18.0 kg/m^2. Participants should not have other neurological diseases besides MS and must agree to use contraception.

What is being tested?

The study is testing SAR443820 against a placebo in people with Multiple Sclerosis over approximately two years. It includes initial double-blind treatment where neither participants nor researchers know who gets the real drug or placebo, followed by an open-label phase where everyone knows they're getting SAR443820.

What are the potential side effects?

Potential side effects are not detailed here but may include reactions related to oral medications such as gastrointestinal discomfort, allergic reactions to ingredients in SAR443820, and any specific side effects that the investigational drug might cause.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 96

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 96

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 96 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Part A: Change from baseline in EDSS Plus

Part A: Cumulative number of new and/or enlarging T2 hyperintense lesions as detected by MRI

Part A: Cumulative number of new gadolinium (Gd)-enhancing T1 hyperintense lesions as detected by magnetic resonance imaging (MRI)

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SAR443820Experimental Treatment1 Intervention

Oral SAR443820

Group II: PlaceboPlacebo Group1 Intervention

Oral placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SAR443820

2022

Completed Phase 1

~120

Do I qualify?Apply below to find out

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

Common treatments for Multiple Sclerosis (MS) often target neuroinflammation and neuroprotection. Glatiramer acetate works by modulating the immune response, reducing inflammation by inducing specific T helper 2 type suppressor cells that migrate to the brain. Dimethyl fumarate, an oral drug, reduces relapse rates and new brain lesions by activating the Nrf2 pathway, which has anti-inflammatory and neuroprotective effects. Masitinib, a tyrosine kinase inhibitor, targets mast cells and microglia to reduce neuroinflammation and slow disease progression. These mechanisms are crucial for MS patients as they help manage symptoms, reduce the frequency of relapses, and slow the progression of disability.

Failed, Interrupted, or Inconclusive Trials on Immunomodulatory Treatment Strategies in Multiple Sclerosis: Update 2015-2020.Oral drugs in multiple sclerosis therapy: an overview and a critical appraisal.Disease-modifying treatments for progressive multiple sclerosis.