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A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
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.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
Alabama Neurology Associates- Site Number : 8400115
Birmingham, Alabama, United States
Dignity Health St. Joseph's Hospital and Medical Center- Site Number : 8400139
Phoenix, Arizona, United States
HonorHealth Neurology- Site Number : 8400074
Scottsdale, Arizona, United States
Perseverance Research Center- Site Number : 8400138
Scottsdale, Arizona, United States
Imaging EndPoints- Site Number : 8400050
Scottsdale, Arizona, United States
Sutter East Bay Medical Foundation- Site Number : 8400134
Berkeley, California, United States
The Research Center of Southern California, LLC- Site Number : 8400023
Carlsbad, California, United States
University of California, Irvine- Site Number : 8400143
Irvine, California, United States
University of California San Diego- Site Number : 8400095
La Jolla, California, United States
Southern California Permanente Medical Group- Site Number : 8400184
Los Angeles, California, United States
Start Date
December 27, 2023
Primary Completion Date
December 23, 2026
Completion Date
March 24, 2028
Last Updated
February 23, 2026
900
ESTIMATED participants
Frexalimab
DRUG
Placebo
DRUG
MRI contrast-enhancing agents
DRUG
Trial Transparency email recommended (Toll free number for US & Canada)
CONTACT
800-633-1610contact-us@sanofi.comLead Sponsor
Sanofi
NCT06276634
NCT07225504
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06809192