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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
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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
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Secondary ID [1]
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U1111-1280-7114
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Secondary ID [2]
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EFC17504
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Universal Trial Number (UTN)
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Trial acronym
FREVIVA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months
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Assessment method [1]
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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
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Timepoint [1]
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Until Week 204
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Secondary outcome [1]
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Time to onset of composite cCDP confirmed over 3 months
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Assessment method [1]
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Timepoint [1]
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Until Week 204
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Secondary outcome [2]
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Time to onset of individual components of the composite, confirmed over 3-months or 6-months
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Assessment method [2]
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Timepoint [2]
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Until Week 204
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Secondary outcome [3]
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Time to onset of confirmed disability improvement (CDI)
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Assessment method [3]
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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.
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Timepoint [3]
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Until Week 204
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Secondary outcome [4]
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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
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Assessment method [4]
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defined as the sum of the individual number of new and/or enlarging T2-hyperintense lesions at all scheduled visits starting after baseline up to and including the EOS visit
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Timepoint [4]
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Until Week 204
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Secondary outcome [5]
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Percent change in brain volume loss as detected by MRI scans at the end of study (EOS) compared to Month 6
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Assessment method [5]
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Timepoint [5]
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From Week 24 to Week 204
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Secondary outcome [6]
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Change in cognitive function at the EOS compared to baseline as assessed by symbol digit modalities test (SDMT)
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Assessment method [6]
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Timepoint [6]
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Baseline, Until Week 204
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Secondary outcome [7]
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Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time
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Assessment method [7]
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Timepoint [7]
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Baseline, Until Week 204
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Secondary outcome [8]
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Change from baseline in patient reported outcome measurement information system (PROMIS) Fatigue multiple sclerosis (MS)-8a over time
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Assessment method [8]
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Timepoint [8]
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Baseline, Until Week 204
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Secondary outcome [9]
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Annualized relapse rate during the study period assessed by protocol defined adjudicated relapses
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Assessment method [9]
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Timepoint [9]
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Until Week 204
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Secondary outcome [10]
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Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation and AE of special interests (AESIs)
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Assessment method [10]
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Timepoint [10]
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Until Week 204
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Secondary outcome [11]
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Number of participants with potentially clinically significant abnormalities (PCSAs) in laboratory tests, ECG, and vital signs during the study period
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Assessment method [11]
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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.
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Timepoint [11]
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Until Week 204
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Secondary outcome [12]
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Number of participants with antibody over time
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Assessment method [12]
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Timepoint [12]
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Until Week 204
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Secondary outcome [13]
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Change from baseline in serum Ig levels over time
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Assessment method [13]
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Timepoint [13]
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Until Week 204
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Secondary outcome [14]
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Change from baseline in plasma neurofilament light chain (NfL) levels over time
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Assessment method [14]
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Timepoint [14]
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Until Week 204
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Secondary outcome [15]
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Frexalimab plasma concentration over time
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Assessment method [15]
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Timepoint [15]
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Until Week 204
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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.
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Minimum age
18
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Maximum age
60
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/12/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
24/03/2028
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Actual
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Sample size
Target
858
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Investigational Site Number : 0360004 - Kogarah
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Recruitment hospital [2]
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Investigational Site Number : 0360001 - Woolloongabba
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Recruitment hospital [3]
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Investigational Site Number : 0360002 - Heidelberg
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment outside Australia
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United States of America
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Alabama
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Kent
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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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 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.
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Trial website
https://clinicaltrials.gov/study/NCT06141486
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
Name
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Trial Transparency email recommended (Toll free number for US & Canada)
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Address
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Phone
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800-633-1610
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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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