Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis

Conditions

• Multiple Sclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Frexalimab — DRUG
  SAR441344 Solution for IV infusion
• Placebo — DRUG
  Solution for IV infusion
• MRI contrast-enhancing agents — DRUG
  IV, as per respective label

Study Details

The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to 36 months double-blind administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria. Study details include: * This event-driven study will end when the target number of 6-month cCDP events is achieved, and the study is expected to last 43 months from randomization of the first participant to the common study end. * The number of scheduled visits will be up to 25 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months. * If the prespecified number of events for 6-month cCDP is not reached by V21/W180, scheduled visits will continue every 3 months.

Key Dates

Start date

Dec 27, 2023

Status verified

May 2026

Primary completion

Mar 24, 2028

Completion

Mar 24, 2028

Study Design

Enrollment

943 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Frexalimab
  Frexalimab IV administration
• Placebo Comparator: Placebo
  Matching placebo

Primary Outcome Measure

Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months in the double-blind treatment period [ Time Frame: Up to 36 months ]

Locations (79)

Find similar trials in Homewood, AL

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