Frexalimab for Multiple Sclerosis

Recruiting at 91 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

129 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What makes the drug Frexalimab unique for treating multiple sclerosis?

Frexalimab is unique because it targets semaphorin 4D, a molecule involved in immune cell signaling, which is different from other treatments that often target B cells or other immune components. This novel mechanism may offer a new approach to managing multiple sclerosis. ^{1 2 3 4 5}

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety/tolerability of the anti-semaphorin 4D Antibody VX15/2503 in a randomized phase 1 trial. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Rituximab for the treatment of multiple sclerosis: a review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of ATX-MS-1467 immunotherapy over 16 weeks in relapsing multiple sclerosis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Phase 1 Evaluation of Elezanumab (Anti-Repulsive Guidance Molecule A Monoclonal Antibody) in Healthy and Multiple Sclerosis Participants. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Phase I study of a humanized anti-CD11/CD18 monoclonal antibody in multiple sclerosis. [2017]