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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06141486




Registration number
NCT06141486
Ethics application status
Date submitted
9/11/2023
Date registered
21/11/2023

Titles & IDs
Public title
Efficacy and Safety Study of Frexalimab (SAR441344) in Adults With Nonrelapsing Secondary Progressive Multiple Sclerosis
Scientific 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
Secondary ID [1] 0 0
U1111-1280-7114
Secondary ID [2] 0 0
EFC17504
Universal Trial Number (UTN)
Trial acronym
FREVIVA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Frexalimab
Treatment: Drugs - Placebo
Treatment: Drugs - MRI contrast-enhancing agents

Experimental: Frexalimab - Frexalimab IV administration

Placebo comparator: Placebo - Matching placebo


Treatment: Drugs: Frexalimab
SAR441344 Solution for IV infusion

Treatment: Drugs: Placebo
Solution for IV infusion

Treatment: Drugs: MRI contrast-enhancing agents
IV, as per respective label
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months in the double-blind treatment period
Timepoint [1] 0 0
Up to 36 months
Secondary outcome [1] 0 0
Time to onset of composite cCDP confirmed over 3 months in the double-blind treatment period
Timepoint [1] 0 0
Up to 36 months
Secondary outcome [2] 0 0
Time to onset of individual components of the composite, confirmed over 3-months or 6 months in the double-blind treatment period
Timepoint [2] 0 0
Up to 36 months
Secondary outcome [3] 0 0
Time to onset of confirmed disability improvement (CDI) in the double-blind treatment period
Timepoint [3] 0 0
Up to 36 months
Secondary outcome [4] 0 0
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 scan as detected by MRI
Timepoint [4] 0 0
Up to 36 months
Secondary outcome [5] 0 0
Percent change in brain volume loss as detected by MRI scans at the end of double-blind treatment period compared to Month 6
Timepoint [5] 0 0
Up to 36 months
Secondary outcome [6] 0 0
Change in cognitive function at the end of double-blind treatment period compared to baseline as assessed by symbol digit modalities test (SDMT)
Timepoint [6] 0 0
Baseline, Up to 36 months
Secondary outcome [7] 0 0
Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time in the double-blind treatment period
Timepoint [7] 0 0
Baseline, Up to 36 months
Secondary outcome [8] 0 0
Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue multiple sclerosis (MS)-8a over time in the double-blind treatment period
Timepoint [8] 0 0
Baseline, Up to 36 months
Secondary outcome [9] 0 0
Annualized relapse rate during the double-blind treatment period assessed by protocol defined adjudicated relapses
Timepoint [9] 0 0
Up to 36 months
Secondary outcome [10] 0 0
Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation and AE of special interests (AESIs)
Timepoint [10] 0 0
Up to 36 months
Secondary outcome [11] 0 0
Number of participants with potentially clinically significant abnormalities (PCSAs) in laboratory tests, ECG, and vital signs during the study period
Timepoint [11] 0 0
Up to 36 months
Secondary outcome [12] 0 0
Number of participants with antibody over time
Timepoint [12] 0 0
Up to 36 months
Secondary outcome [13] 0 0
Change from baseline in serum Ig levels over time
Timepoint [13] 0 0
Up to 36 months
Secondary outcome [14] 0 0
Change from baseline in plasma neurofilament light chain (NfL) levels over time in the double-blind treatment period
Timepoint [14] 0 0
Up to 36 months
Secondary outcome [15] 0 0
Frexalimab plasma concentration over time in the double-blind treatment period
Timepoint [15] 0 0
Up to 36 months

Eligibility
Key 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.
* For patients eligible to be treated with siponimod: 1) does not tolerate it due to side effects or safety reasons, or 2) has failed siponimod treatment due to perceived lack of efficacy, or 3) has declined siponimod treatment.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/03/2028
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360005 - Saint Leonards
Recruitment hospital [2] 0 0
Investigational Site Number : 0360001 - Woolloongabba
Recruitment hospital [3] 0 0
Investigational Site Number : 0360002 - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3084 - Melbourne
Recruitment outside Australia
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United States of America
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VAN
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Ivano-Frankivsk
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Kyiv
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Newcastle Upon Tyne
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Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free number for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06141486