What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis, particularly monoclonal antibodies like natalizumab, ocrelizumab, and alemtuzumab, have a range of side effects. Natalizumab can increase the risk of progressive multifocal leukoencephalopathy (PML), a serious brain infection. Ocrelizumab may cause infusion-related reactions, respiratory infections, and an increased risk of malignancies. Alemtuzumab is associated with autoimmune conditions, including thyroid disorders and immune thrombocytopenia, as well as infusion reactions and infections. These treatments aim to modulate the immune system but come with significant risks that need to be managed under medical supervision.

What prior FDA approvals exist?

The FDA has approved several disease-modifying therapies for the treatment of Multiple Sclerosis (MS). These include oral medications like dimethyl fumarate (BG-12), which has shown efficacy in reducing relapse rates and new brain lesions, and injectable treatments like glatiramer acetate. Monoclonal antibodies such as natalizumab and ocrelizumab have also been approved, targeting specific immune cells to reduce disease activity. While Frexalimab, an Anti-CD40 Ligand Monoclonal Antibody, is still under study, it represents a novel approach in the ongoing effort to manage MS by modulating immune responses.

What other types of research exist?

Promising novel alternatives to Frexalimab for Multiple Sclerosis patients include: <ol> <li>Ocrelizumab (Anti-CD20 Monoclonal Antibody) - Demonstrated efficacy in reducing relapse rates and slowing disease progression.</li> <li></li> </ol> Ofatumumab (Anti-CD20 Monoclonal Antibody) - Shown to be effective in reducing annualized relapse rates in relapsing MS. 3. Alemtuzumab (Anti-CD52 Monoclonal Antibody) - Proven efficacy in treatment-naive patients and those with inadequate response to first-line therapy. 4. Eculizumab (Anti-C5 Monoclonal Antibody) - Under investigation for its potential benefits in MS treatment.

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Monoclonal Antibodies

Frexalimab for Multiple Sclerosis (FREXALT Trial)

Verified Trial

Phase 3

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

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

Must have

Have you had a relapse in the past year?

Are you willing to use contraception during this study?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until week 168

Awards & highlights

Pivotal Trial

Summary

This trial compares a new treatment, frexalimab, with an existing pill, teriflunomide, in adults aged 18-55 who have relapsing multiple sclerosis. The study aims to see if frexalimab can reduce the frequency of symptom relapses better than teriflunomide. Participants will be monitored over several years.

Who is the study for?

Adults aged 18 to 55 with relapsing forms of multiple sclerosis (RMS) can join this trial. They must have had at least one relapse in the past year or two in the last two years, or a recent MRI showing specific brain lesions. Participants need an EDSS score of 5.5 or less and must follow local contraception rules.

What is being tested?

The trial is testing Frexalimab's effect on reducing annualized relapse rate compared to Teriflunomide, a daily oral medication for RMS. It includes regular visits over approximately 20-40 months, with MRIs and other assessments to track progress.

What are the potential side effects?

Potential side effects may include reactions related to immune system changes due to Frexalimab, digestive issues from activated charcoal or cholestyramine, and typical contrast agent reactions during MRI scans.

Eligibility Criteria

Inclusion Criteria

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

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You must use approved birth control methods as required by local rules for participating in the study.

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Your EDSS score is less than or equal to 5.5 at the first visit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until week 168

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until week 168

This trial's timeline: 3 weeks for screening, Varies for treatment, and until week 168 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses

Secondary study objectives

Number of participants with potentially clinically significant abnormality (PCSAs) in laboratory tests, ECG and vital signs during the study period

Progression independent of relapse activity defined as the time to onset of 6-month cCDW

Time to onset of composite confirmed disability worsening (cCDW)

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FrexalimabExperimental Treatment5 Interventions

Participants will receive Frexalimab infusion and placebo tablet.

Group II: TeriflunomideActive Control5 Interventions

Participants will receive teriflunomide tablet and placebo infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Activated charcoal

2022

Completed Phase 1

~40

Placebo tablet

2020

Completed Phase 4

~6240

Cholestyramine

2018

Completed Phase 4

~340

0 / 4Eligibility 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

Common treatments for Multiple Sclerosis (MS) include immunomodulatory and immunosuppressive therapies that target various aspects of the immune system to reduce inflammation and prevent immune-mediated damage to the central nervous system. Fingolimod traps immune cells in lymph nodes, preventing them from reaching the brain and spinal cord. Dimethyl fumarate activates the Nrf2 pathway, providing anti-inflammatory and neuroprotective effects. Teriflunomide inhibits pyrimidine synthesis, reducing the proliferation of activated lymphocytes. Monoclonal antibodies like alemtuzumab deplete specific immune cells, and natalizumab blocks immune cell migration into the central nervous system. These mechanisms are crucial for MS patients as they help manage relapses, reduce new lesion formation, and slow disease progression, thereby improving quality of life.

Mode of action and clinical studies with alemtuzumab.New and emerging immune-targeted drugs for the treatment of multiple sclerosis.