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HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

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Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

A Study to Evaluate the Effect of SAR443820 on Serum Neurofilament Levels in Male and Female Adult Participants With Multiple Sclerosis

Study Purpose

This is a Phase 2, randomized, double-blind, placebo-controlled 2 parallel-arm study to assess the effect on serum neurofilament light chain (sNfL), safety and tolerability of oral SAR443820 compared to placebo in male and female participants aged 18 to 60 years with relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) (relapsing or non-relapsing), or primary progressive multiple sclerosis (PPMS) followed by an open-label long-term extension period. The total study duration is approximately 100 weeks and includes the following: 4-week screening period 48-week double-blind treatment period (Part A) 48-week open-label long-term extension period (Part B)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male or female, 18 to 60 years (inclusive) of age, at the time of signing the informed consent.
  • - Participants with diagnosis of RRMS, SPMS (relapsing or non-relapsing) or primary progressive subtype according to the 2017 revision of the McDonald diagnostic criteria (SPMS diagnostic criteria according to initial relapsing remitting disease course followed by progression with or without occasional relapses, minor remissions, and plateaus; progression denotes the continuous worsening of neurological impairment over at least 6 months).
  • - Participants with Expanded Disability Status Scale (EDSS) score of 26 inclusive at screening.
  • - Participants who are either untreated or in the opinion of the Investigator are stable on an allowed disease-modifying therapy (DMT) (interferons, glatiramer acetate, fumarates, or teriflunomide) for at least the past 3 months, AND not anticipated to require a change in multiple sclerosis (MS) treatment for the duration of Part A and Part B (through Week 96); in Part B changes in dose of allowed DMTs or transition to other allowed DMTs is permitted).
  • - Participants with body weight at least 45 kg and body mass index (BMI) at least 18.0 kg/m^2.
  • - 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:

  • - Participants with immunodeficiency syndromes or other autoimmune diseases requiring immunosuppressive therapy.
  • - Participants with a history of seizures or epilepsy (history of febrile seizure during childhood is allowed).
  • - Participants with known clinical relapse (acute or subacute episodes of new or increasing neurological dysfunction followed by full or partial recovery, in absence of fever or infection) within 8 weeks of screening.
  • - Participants with neurological disease history other than MS, eg, head trauma within 3 months, cerebrovascular disease, and vascular dementia.
  • - Participants with a history of recent serious infection (eg, pneumonia, septicemia) within 4 weeks of screening; an infection requiring hospitalization or intravenous antibiotics, antivirals, or antifungals within 4 weeks of screening; or chronic bacterial infections (such as tuberculosis) deemed unacceptable, as per Investigator's judgment.
  • - Participants who have significant cognitive impairment, psychiatric disease, other neurodegenerative disorders (eg, Parkinson disease or Alzheimer disease), substance abuse, or any other conditions that would make the participants unsuitable for participating in the study or could interfere with assessment or completing the study in the opinion of the Investigator.
  • - Participants with a documented history of attempted suicide over the 24 weeks prior to the Screening Visit, presents with suicidal ideation of category 4 or 5 on the Columbia Suicide Severity Rating Scale (CSSRS), or if in the Investigator's judgment, the participant is at risk for a suicide attempt.
  • - Participants with a history of unstable or severe cardiac, pulmonary, oncological, hepatic, or renal disease or another medically significant illness other than MS precluding their safe participation in this study.
  • - Participants who received a live vaccine within 14 days before the Screening Visit.
  • - Participants with a known history of allergy to any ingredients of SAR443820 (mannitol, lactose monohydrate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and microcrystalline cellulose).
  • - Participants with a current use of any medications that are moderate or strong inhibitors or strong inducers of cytochrome P450 3A4 (CYP3A4).
  • - Participants with a current use of any of the following medications/treatments: fampridine/dalfampridine, ofatumumab, fingolimod, cladribine, siponimod, ponesimod, ozanimod, alemtuzumab, mitoxantrone, ocrelizumab, natalizumab, or similar approved compounds but with different trade names and any unapproved treatments or therapies for MS; any DMTs newly approved after January 2023 that are marketed at any time during the course of the double-blind study period.
These medications are not allowed within 5 half-lives before the Screening Visit and for the duration of Part A and Part B.
  • - Participants who have prior/concurrent clinical study enrollment, ie, the participant has taken other investigational drugs within 4 weeks or 5 half-lives, whichever is longer, before the first Screening Visit; concurrent or recent participation in non-interventional studies may be permitted.
Participants with abnormal laboratory test(s) at the Screening Visit:
  • - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3.0 x upper limit of normal (ULN) - Bilirubin more than 1.5 x ULN; unless the participant has documented Gilbert syndrome (isolated bilirubin more than 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%) - Serum albumin less than 3.5 g/dL.
  • - Estimated Glomerular filtration rate less than 60 mL/min/1.73 m^2 (Modification of Diet in Renal Disease [MDRD]) - Other abnormal laboratory values or electrocardiogram (ECG) changes that are deemed clinically significant as per Investigator's judgment.
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05630547
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sanofi
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Clinical Sciences & Operations
Principal Investigator Affiliation Sanofi
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, Canada, China, France, Italy, Poland, Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Sclerosis
Additional Details

Approximately 100 weeks

Arms & Interventions

Arms

Experimental: SAR443820

Oral SAR443820

Placebo Comparator: Placebo

Oral placebo

Interventions

Drug: - SAR443820

Tablet by oral administration

Other: - Placebo

Tablet by oral administration

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Investigational Site Number :0560001, Bruxelles, Belgium

Status

Recruiting

Address

Investigational Site Number :0560001

Bruxelles, , BE-1200

Site Contact

[email protected]

800-633-1610

Investigational Site Number :1240002, Ottawa, Ontario, Canada

Status

Recruiting

Address

Investigational Site Number :1240002

Ottawa, Ontario, K1H 8L6

Site Contact

[email protected]

800-633-1610

Investigational Site Number :1240001, Gatineau, Quebec, Canada

Status

Recruiting

Address

Investigational Site Number :1240001

Gatineau, Quebec, J8Y 1W2

Site Contact

[email protected]

800-633-1610

Investigational Site Number :1240003, Levis, Quebec, Canada

Status

Recruiting

Address

Investigational Site Number :1240003

Levis, Quebec, G6W 0M5

Site Contact

[email protected]

800-633-1610

Investigational Site Number :1560003, Chengdu, China

Status

Recruiting

Address

Investigational Site Number :1560003

Chengdu, , 610041

Site Contact

[email protected]

800-633-1610

Investigational Site Number :1560002, Shanghai, China

Status

Recruiting

Address

Investigational Site Number :1560002

Shanghai, , 200040

Site Contact

[email protected]

800-633-1610

Investigational Site Number :1560004, Xi'an, China

Status

Recruiting

Address

Investigational Site Number :1560004

Xi'an, , 710038

Site Contact

[email protected]

800-633-1610

Investigational Site Number :2500004, Caen, France

Status

Recruiting

Address

Investigational Site Number :2500004

Caen, , 14033

Site Contact

[email protected]

800-633-1610

Investigational Site Number :2500002, Nice, France

Status

Recruiting

Address

Investigational Site Number :2500002

Nice, , 06001

Site Contact

[email protected]

800-633-1610

Investigational Site Number :2500001, Paris, France

Status

Recruiting

Address

Investigational Site Number :2500001

Paris, , 75013

Site Contact

[email protected]

800-633-1610

Investigational Site Number :2500003, Strasbourg, France

Status

Recruiting

Address

Investigational Site Number :2500003

Strasbourg, , 67098

Site Contact

[email protected]

800-633-1610

Investigational Site Number :3800001, Pozzilli, Isernia, Italy

Status

Recruiting

Address

Investigational Site Number :3800001

Pozzilli, Isernia, 86077

Site Contact

[email protected]

800-633-1610

Investigational Site Number :6160002, Katowice, Slaskie, Poland

Status

Recruiting

Address

Investigational Site Number :6160002

Katowice, Slaskie, 40-571

Site Contact

[email protected]

800-633-1610

Investigational Site Number :6160005, Katowice, Slaskie, Poland

Status

Recruiting

Address

Investigational Site Number :6160005

Katowice, Slaskie, 40-686

Site Contact

[email protected]

800-633-1610

Investigational Site Number :6160004, Plewiska, Wielkopolskie, Poland

Status

Recruiting

Address

Investigational Site Number :6160004

Plewiska, Wielkopolskie, 62-064

Site Contact

[email protected]

800-633-1610

Investigational Site Number :7240002, Sevilla, Andalucia, Spain

Status

Recruiting

Address

Investigational Site Number :7240002

Sevilla, Andalucia, 41009

Site Contact

[email protected]

800-633-1610

Investigational Site Number :7240001, Barcelona, Barcelona [Barcelona], Spain

Status

Recruiting

Address

Investigational Site Number :7240001

Barcelona, Barcelona [Barcelona], 08035

Site Contact

[email protected]

800-633-1610

Investigational Site Number :7240004, Madrid, Comunidad De Madrid, Spain

Status

Recruiting

Address

Investigational Site Number :7240004

Madrid, Comunidad De Madrid, 28007

Site Contact

[email protected]

800-633-1610

Investigational Site Number :7240003, Madrid, Madrid, Comunidad De, Spain

Status

Recruiting

Address

Investigational Site Number :7240003

Madrid, Madrid, Comunidad De, 28040

Site Contact

[email protected]

800-633-1610

Investigational Site Number :7240006, Madrid, Spain

Status

Recruiting

Address

Investigational Site Number :7240006

Madrid, , 28034

Site Contact

[email protected]

800-633-1610

Investigational Site Number :7240005, Murcia, Spain

Status

Recruiting

Address

Investigational Site Number :7240005

Murcia, , 30120

Site Contact

[email protected]

800-633-1610

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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