Frexalimab for Multiple Sclerosis

Not currently recruiting at 107 trial locations

Overseen By Trial Transparency email recommended (Toll free number for US & Canada)

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must not be taking: Antithrombotics, Investigational drugs

Disqualifiers: PPMS, HIV, Hepatitis B, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 292 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SAR441344 (also known as Frexalimab) for people with multiple sclerosis (MS), specifically those experiencing relapses or new active brain lesions. The main goal is to determine if the treatment can reduce the number of new active brain lesions, which are areas of brain damage. Researchers also assess the treatment's safety and how it behaves in the body. Participants may receive the treatment through a shot under the skin or an IV infusion. The trial seeks individuals diagnosed with relapsing MS who have recently experienced relapses or active brain lesions. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have taken certain forbidden medications within a specified time before the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that SAR441344 is likely to be safe for humans?

Research shows that SAR441344, also known as Frexalimab, has been tested for safety in people with multiple sclerosis. In past studies, Frexalimab showed promising results and was generally well-tolerated by patients. Some unwanted side effects were reported, but they were usually mild, such as headaches and minor reactions at the injection site.

Frexalimab is being tested in two forms: one injected under the skin and another given through a vein. Both forms have been studied before, helping researchers understand their safety. So far, these studies have found no major safety concerns.

This trial is in Phase 2, meaning the treatment is still being studied for efficacy and safety. Reaching this phase usually indicates that earlier tests in humans did not reveal major safety problems.

Overall, while Frexalimab is still under investigation, current data suggests it is relatively safe for most people. Always consult a healthcare provider when considering joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple sclerosis?

Researchers are excited about SAR441344 because it targets CD40L, a protein involved in the immune response, offering a new approach for treating multiple sclerosis (MS). Unlike standard MS treatments like interferons or monoclonal antibodies that primarily modulate the immune system, SAR441344's mechanism potentially offers more precise intervention with fewer side effects. Additionally, SAR441344 is being tested in both subcutaneous and intravenous forms, providing flexibility in how it can be administered to patients. This adaptability, combined with its unique mechanism, has the potential to improve patient outcomes and enhance quality of life for those with MS.

What evidence suggests that Frexalimab might be an effective treatment for multiple sclerosis?

Research has shown that frexalimab (SAR441344) may help treat multiple sclerosis. In this trial, participants will receive frexalimab either subcutaneously (SC) or intravenously (IV), or a placebo. One study found that frexalimab significantly reduced the number of new active brain lesions, key indicators of the disease's activity. Specifically, those who received the treatment experienced a very low relapse rate of 0.04 per year, suggesting it may help prevent disease progression. Additionally, frexalimab appears to lower inflammation, potentially reducing overall disease activity. These findings suggest frexalimab could effectively manage multiple sclerosis. ^{1 3 6 7 8}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Exclusion Criteria

You tested positive for Hepatitis C within the last 3 months.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive SAR441344 or placebo for up to 292 weeks

292 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SAR441344

Trial Overview 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.

How Is the Trial Designed?

Group I: Subcutaneous (SC) SAR441344 Experimental Treatment 2 Interventions

SAR441344 SC

Group II: Intravenous (IV) SAR441344 Experimental Treatment 2 Interventions

SAR441344 IV

Group III: IV Placebo Placebo Group 2 Interventions

Placebo IV

Group IV: SC Placebo Placebo Group 2 Interventions

Placebo SC

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

Elezanumab, a monoclonal antibody targeting RGMa, was found to be safe and well-tolerated in a study involving 47 healthy participants and 20 individuals with multiple sclerosis, with no significant adverse events reported.

The drug demonstrated effective central nervous system penetration and reduced levels of free RGMa in cerebrospinal fluid, indicating its potential to modulate inflammatory pathways in multiple sclerosis, particularly at higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 Evaluation of Elezanumab (Anti-Repulsive Guidance Molecule A Monoclonal Antibody) in Healthy and Multiple Sclerosis Participants. Kalluri, HV., Rosebraugh, MR., Misko, TP., et al.[2023]

VX15/2503 was found to be safe and well tolerated in a study involving 50 adult patients with multiple sclerosis, with no serious dose-limiting toxicities reported and only mild adverse events observed.

The pharmacokinetics showed that higher doses of VX15/2503 led to increased serum concentrations and prolonged effects, with significant cellular saturation lasting over 155 days, indicating potential for long-term therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety/tolerability of the anti-semaphorin 4D Antibody VX15/2503 in a randomized phase 1 trial. LaGanke, C., Samkoff, L., Edwards, K., et al.[2022]

In two open-label trials involving 80 participants with relapsing multiple sclerosis, the antigen-specific immunotherapy ATX-MS-1467 showed a significant reduction in new T1 gadolinium-enhanced lesions, indicating its potential efficacy in managing the disease.

The treatment was well-tolerated with no significant safety concerns reported, suggesting that the slow titration and longer treatment duration may enhance its therapeutic effects without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of ATX-MS-1467 immunotherapy over 16 weeks in relapsing multiple sclerosis. Chataway, J., Martin, K., Barrell, K., et al.[2019]

The humanized anti-CD11/CD18 monoclonal antibody Hu23F2G was well-tolerated in a phase I study involving 24 patients with multiple sclerosis, with only a few adverse effects reported, including urinary tract infections and gingivitis.

Hu23F2G effectively saturated CD11/CD18 on leukocytes at doses of 0.2 mg/kg and above, leading to a significant reduction in leukocyte migration, although the study did not assess its clinical efficacy, indicating the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of a humanized anti-CD11/CD18 monoclonal antibody in multiple sclerosis. Bowen, JD., Petersdorf, SH., Richards, TL., et al.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06141473

NCT06141473 | Efficacy and Safety Studies of Frexalimab ... The purpose of each study is to independently measure the annualized relapse rate (ARR) with administration of frexalimab compared to a daily oral dose of ...

2. congress.sanofimedical.com congress.sanofimedical.com/s3fs-public/2024-09/Safety%20and%20Efficacy%20of%20Frexalimab%20in%20the%20Treatment%20of%20Relapsing%20Multiple%20Sclerosis%2018-month%20Results%20from%20the%20Phase%202%20Open-Label%20Extension.pdf

Safety and Efficacy of Frexalimab in the Treatment of ... Safety and Efficacy of Frexalimab in the Treatment of. Relapsing Multiple Sclerosis: 18-month Results from the Phase 2 Open-Label Extension.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04879628

NCT04879628 | Proof-of-concept Study for SAR441344 ... Primary Objective: To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions. Secondary Objective:.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11623868/

Frexalimab (SAR441344) as a potential multiautoimmune ... Multiple clinical trials have demonstrated Frexalimab's favorable safety profile, marking it as superior to first-generation drugs by minimizing side effects.

5. sanofi.com sanofi.com/en/media-room/press-releases/2024/2024-04-17-05-00-00-2864225

Press Release: New 48-week frexalimab phase 2 data ... Participants who continued receiving high-dose frexalimab experienced a low annualized relapse rate (ARR) of 0.04 (95% CI: 0.01, 0.18) over the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06141486

NCT06141486 | Efficacy and Safety Study of Frexalimab ... The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability ...

7. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//us/en/listing/312900/efficacy-and-safety-study/

Efficacy and Safety Study of Frexalimab (SAR441344) in This study investigates the efficacy and safety of an investigational medication in delaying disability progression in individuals with non-relapsing ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06141473?term=SAR441344&rank=6

Efficacy and Safety Studies of Frexalimab ( SAR441344 ) in ... A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm, ...