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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06141486




Registration number
NCT06141486
Ethics application status
Date submitted
9/11/2023
Date registered
21/11/2023
Date last updated
10/06/2024

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
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
Timepoint [1] 0 0
Until Week 204
Secondary outcome [1] 0 0
Time to onset of composite cCDP confirmed over 3 months
Timepoint [1] 0 0
Until Week 204
Secondary outcome [2] 0 0
Time to onset of individual components of the composite, confirmed over 3-months or 6-months
Timepoint [2] 0 0
Until Week 204
Secondary outcome [3] 0 0
Time to onset of confirmed disability improvement (CDI)
Timepoint [3] 0 0
Until Week 204
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 month
Timepoint [4] 0 0
Until Week 204
Secondary outcome [5] 0 0
Percent change in brain volume loss as detected by MRI scans at the end of study (EOS) compared to Month 6
Timepoint [5] 0 0
From Week 24 to Week 204
Secondary outcome [6] 0 0
Change in cognitive function at the EOS compared to baseline as assessed by symbol digit modalities test (SDMT)
Timepoint [6] 0 0
Baseline, Until Week 204
Secondary outcome [7] 0 0
Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time
Timepoint [7] 0 0
Baseline, Until Week 204
Secondary outcome [8] 0 0
Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue multiple sclerosis (MS)-8a over time
Timepoint [8] 0 0
Baseline, Until Week 204
Secondary outcome [9] 0 0
Annualized relapse rate during the study period assessed by protocol defined adjudicated relapses
Timepoint [9] 0 0
Until Week 204
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
Until Week 204
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
Until Week 204
Secondary outcome [12] 0 0
Number of participants with antibody over time
Timepoint [12] 0 0
Until Week 204
Secondary outcome [13] 0 0
Change from baseline in serum Ig levels over time
Timepoint [13] 0 0
Until Week 204
Secondary outcome [14] 0 0
Change from baseline in plasma neurofilament light chain (NfL) levels over time
Timepoint [14] 0 0
Until Week 204
Secondary outcome [15] 0 0
Frexalimab plasma concentration over time
Timepoint [15] 0 0
Until Week 204

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.
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.

- 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
858
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Investigational Site Number : 0360004 - Kogarah
Recruitment hospital [2] 0 0
Investigational Site Number : 0360002 - Heidelberg
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
China
State/province [24] 0 0
Guangzhou
Country [25] 0 0
Japan
State/province [25] 0 0
Kyoto
Country [26] 0 0
Korea, Republic of
State/province [26] 0 0
Seoul-teukbyeolsi
Country [27] 0 0
Puerto Rico
State/province [27] 0 0
Guaynabo
Country [28] 0 0
Turkey
State/province [28] 0 0
Kocaeli
Country [29] 0 0
Turkey
State/province [29] 0 0
Mersin
Country [30] 0 0
Turkey
State/province [30] 0 0
Samsun
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Kent

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

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06141486
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06141486