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

Sanofi

Status and phase: Enrolling; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: Frexalimab; Drug: Placebo; Drug: MRI contrast-enhancing agents

Study type: Interventional

Funder types: Industry

Identifiers

NCT06141486

2023-504359-29 (Other Identifier)

U1111-1280-7114 (Registry Identifier)

EFC17504

Details and patient eligibility

About

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 approximately 51 months 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 have variable duration ranging from approximately 27 to 51 months.
• The study intervention duration will vary ranging from approximately 12 to 51 months.
• The number of scheduled visits will be up to 27 (including 3 follow-up visits) with a visit frequency of every month for the first 6 months and then every 3 months.

Enrollment: 858 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria.
• Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013 endorsed by an Adjudication Committee.
• Participant must have documented evidence of disability progression observed during the 12 months before screening. Eligibility will be analyzed by an Adjudication Committee.
• Absence of clinical relapses for at least 24 months.
• The participant must have an EDSS score at screening from 3.0 to 6.5 points, inclusive.
• 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

• The participant has a history of infection or may be at risk for infection.
• The presence of psychiatric disturbance or substance abuse.
• History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.
• History or current hypogammaglobulinemia defined by values below the lower limit of normal (LLN).
• A history or presence of disease that can mimic MS symptoms, such as, but not limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus, Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis.
• The participant has sensitivity to any of the study interventions, or components thereof, or has a drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
• The participant was previously exposed to frexalimab.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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858 participants in 2 patient groups, including a placebo group

Frexalimab

Experimental group

Description:

Frexalimab IV administration

Treatment:

Drug: MRI contrast-enhancing agents

Drug: Frexalimab

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: MRI contrast-enhancing agents

Drug: Placebo