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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06141486
• Other study ID #: EFC17504
• Secondary ID: U1111-1280-71142
• Status: Recruiting
• Phase: Phase 3
• Start date: December 27, 2023
• Est. completion date: March 24, 2028

Study information

• Verified date: June 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free number for US &
• Phone: 800-633-1610
• Email: contact-us[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 27 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 858
• Est. completion date: March 24, 2028
• Est. primary completion date: December 23, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Australia	Investigational Site Number : 0360002	Heidelberg	Victoria
Australia	Investigational Site Number : 0360004	Kogarah	New South Wales
Canada	Investigational Site Number : 1240001	Gatineau	Quebec
Canada	Investigational Site Number : 1240008	Levis	Quebec
Canada	Investigational Site Number : 1240009	Montreal	Quebec
Canada	Investigational Site Number : 1240016	Montreal	Quebec
Canada	Investigational Site Number : 1240003	Quebec
Canada	Investigational Site Number : 1240006	Sherbrooke	Quebec
China	Investigational Site Number : 1560002	Guangzhou
Japan	Investigational Site Number : 3920001	Kyoto-shi	Kyoto
Korea, Republic of	Investigational Site Number : 4100002	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Investigational Site Number : 4100003	Seoul	Seoul-teukbyeolsi
Puerto Rico	San Juan MS Center Site Number : 8400106	Guaynabo
Turkey	Investigational Site Number : 7920001	Kocaeli
Turkey	Investigational Site Number : 7920006	Mersin
Turkey	Investigational Site Number : 7920004	Samsun
United Kingdom	Investigational Site Number : 8260003	Kent
United States	Dent Neurologic Institute Site Number : 8400129	Amherst	New York
United States	Alabama Neurology Associates Site Number : 8400115	Birmingham	Alabama
United States	The Research Center of Southern California, LLC Site Number : 8400023	Carlsbad	California
United States	Piedmont Healthcare/Research Site Number : 8400002	Charlotte	North Carolina
United States	Riverhills Neuroscience - Norwood Site Number : 8400007	Cincinnati	Ohio
United States	MS & Neuromuscular Center of Excellence Site Number : 8400015	Clearwater	Florida
United States	Ohio State University Site Number : 8400009	Columbus	Ohio
United States	The Boster Center for Multiple Sclerosis Site Number : 8400006	Columbus	Ohio
United States	Stony Brook University Health Sciences Center Site Number : 8400094	East Setauket	New York
United States	Michigan Institute For Neurological Disorders Site Number : 8400004	Farmington Hills	Michigan
United States	University of Iowa Hospitals and Clinics Site Number : 8400029	Iowa City	Iowa
United States	HOPE Neurology Site Number : 8400019	Knoxville	Tennessee
United States	Lou Ruvo Center for Brain Health Site Number : 8400045	Las Vegas	Nevada
United States	International Neurorehabilitation Institute Site Number : 8400089	Lutherville	Maryland
United States	Neurology Associates, PA Site Number : 8400010	Maitland	Florida
United States	Neuroscience Institute Center Site Number : 8400053	Merrillville	Indiana
United States	Wheaton Franciscan Healthcare Site Number : 8400034	Milwaukee	Wisconsin
United States	Icahn School of Medicine at Mount Sinai Site Number : 8400011	New York	New York
United States	Hoag Memorial Hospital Site Number : 8400031	Newport Beach	California
United States	Riverside Hampton Roads Neurology Site Number : 8400132	Newport News	Virginia
United States	Consultants In Neurology Site Number : 8400020	Northbrook	Illinois
United States	Oklahoma Medical Research Foundation Site Number : 8400039	Oklahoma City	Oklahoma
United States	College Park Family Care Center Site Number : 8400032	Overland Park	Kansas
United States	Memorial Healthcare Institute for Neuroscience Site Number : 8400123	Owosso	Michigan
United States	Sharlin Health & Neurology Site Number : 8400016	Ozark	Missouri
United States	Velocity Clinical Research, Inc Site Number : 8400014	Raleigh	North Carolina
United States	Washington University School of Medicine Site Number : 8400076	Saint Louis	Missouri
United States	Savannah Neurology Specialists Site Number : 8400061	Savannah	Georgia
United States	Imaging EndPoints Site Number : 8400050	Scottsdale	Arizona
United States	Perseverance Research Center Site Number : 8400138	Scottsdale	Arizona
United States	Texas Institute for Neuroogical Disorders-Sherman Site Number : 8400018	Sherman	Texas
United States	Springfield Clinic, LLP Site Number : 8400043	Springfield	Illinois
United States	Axiom Clinical Research of Florida Site Number : 8400049	Tampa	Florida
United States	The Elliot Lewis Center for Multiple Sclerosis Care Site Number : 8400033	Wellesley	Massachusetts
United States	Regina Berkovich, MD, PhD Site Number : 8400005	West Hollywood	California
United States	Premiere Research Institute at Palm Beach Neurology Site Number : 8400105	West Palm Beach	Florida
United States	Atrium Health Wake Forest Baptist Site Number : 8400040	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  Japan,  Korea, Republic of,  Puerto Rico,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months	Defined as Increase from the baseline expanded disability status scale (EDSS) score of =1.0 point when the baseline is <5.5, or =0.5 point when the baseline is =5.5, OR Increase of =20% from the baseline time in the 9 hole peg test (9HPT),OR Increase of =20% from the baseline time in the timed 25 foot walk (T25FW) test	Until Week 204
Secondary	Time to onset of composite cCDP confirmed over 3 months		Until Week 204
Secondary	Time to onset of individual components of the composite, confirmed over 3-months or 6-months		Until Week 204
Secondary	Time to onset of confirmed disability improvement (CDI)	defined as decrease from the baseline EDSS score of =1.0 or = 0.5 points when baseline is =5.5 or >5.5 points, respectively, confirmed over 6 months.	Until Week 204
Secondary	Number of new and/or enlarging T2hyperintense lesions per scan as detected by MRI, and number of new and/or enlarging T2-hyperintense lesions per month		Until Week 204
Secondary	Percent change in brain volume loss as detected by MRI scans at the end of study (EOS) compared to Month 6		From Week 24 to Week 204
Secondary	Change in cognitive function at the EOS compared to baseline as assessed by symbol digit modalities test (SDMT)		Baseline, Until Week 204
Secondary	Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time		Baseline, Until Week 204
Secondary	Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue multiple sclerosis (MS)-8a over time		Baseline, Until Week 204
Secondary	Annualized relapse rate during the study period assessed by protocol defined adjudicated relapses		Until Week 204
Secondary	Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation and AE of special interests (AESIs)		Until Week 204
Secondary	Number of participants with potentially clinically significant abnormalities (PCSAs) in laboratory tests, ECG, and vital signs during the study period	12-lead ECG (electrocardiogram) will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals.	Until Week 204
Secondary	Number of participants with antibody over time		Until Week 204
Secondary	Change from baseline in serum Ig levels over time		Until Week 204
Secondary	Change from baseline in plasma neurofilament light chain (NfL) levels over time		Until Week 204
Secondary	Frexalimab plasma concentration over time		Until Week 204

External Links

•   Multiple Sclerosis Website