Proof-of-concept Study for SAR441344 in Relapsing Multiple Sclerosis

  • STATUS
    Recruiting
  • End date
    Dec 13, 2023
  • participants needed
    120
  • sponsor
    Sanofi
Updated on 13 May 2022
body mass index
MRI
disease or disorder
relapsing multiple sclerosis

Summary

Primary Objective:

To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions

Secondary Objective:

  • To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures
  • To evaluate the safety and tolerability of SAR441344
  • To evaluate pharmacokinetics of SAR441344

Description

The duration of each participant will be no longer than 116 weeks in both parts of the study, including 4 weeks of screening, at maximum 88 weeks of treatment and 24 weeks of follow-up.

Details
Condition Multiple Sclerosis
Treatment Placebo SC, Placebo IV, SAR441344 IV, SAR441344 SC, MRI contrast-enhancing preparations
Clinical Study IdentifierNCT04879628
SponsorSanofi
Last Modified on13 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent
The participant must have been diagnosed with RMS (relapsing-remitting MS and secondary progressive MS participants with relapses) according to the 2017 revision of the McDonald diagnostic criteria
The participant must have at least 1 documented relapse within the previous year, or ≥2 documented relapses within the previous 2 years, or ≥1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months and prior to screening
Body weight within 45 to 120 kg (inclusive) and body mass index (BMI) within the range 18.0 to 35.0 kg/m2 (inclusive) at Screening
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Capable of giving signed informed consent

Exclusion Criteria

The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS
The participant has conditions or situations that would adversely affect participation in this study
The participant has a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study
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
Allergies to humanized monoclonal antibodies or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule
The participant has received any of the forbidden medications/treatments within the specified time frame before any baseline assessment
The participant has taken other investigational drug within 3 months or 5-half-live, whichever is longer, before the screening visit
The participant has an EDSS score >5.5 at the first screening visit
The participant has had a relapse in the 30 days prior to randomization
Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission
Abnormal laboratory test(s) at Screening
Presence of Hepatitis B surface antigen (HBsAg) or anti-Hepatitis B core antibodies (anti-HBc Ab) at screening or within 3 months prior to first dose of study intervention
Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study intervention
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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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