Frexalimab for Multiple Sclerosis

Recruiting in Palo Alto (17 mi)

+91 other locations

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sanofi

Prior Safety Data

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.

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.

I am between 18 and 55 years old.

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

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

Exclusion Criteria

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.

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

I have tested positive for Hepatitis B recently.

Participant Groups

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.

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