Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis

Investigating the Effects of an Investigational Medication on MS

Not Recruiting
18 years - 55 years
All
Phase 2
129 participants needed

Study Overview

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

Study Details

The duration of each participant will be no longer than 320weeks in both parts of the study, including 4 weeks of screening, at maximum 292 weeks of treatment and 24 weeks of follow-up.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Multiple Sclerosis
  • Age: 18 years - 55 years
  • Gender: All

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.

Updated on 15 Aug 2024. Study ID: NCT04879628

This study investigates the effects of an investigational medication on people with certain types of Multiple Sclerosis (MS). Multiple Sclerosis is a disease where the immune system attacks the protective covering of nerves, causing communication problems between the brain and the rest of the body. The study aims to see if the medication can reduce new active brain lesions, which are areas of damage in the brain, and assess its impact on overall disease activity.

Participants in the study will undergo various procedures including MRI scans to measure brain lesions and other disease activities. The study will also evaluate the safety and tolerability of the investigational medication, which means checking for side effects and how well participants can manage them. Additionally, the study will look at how the medication is processed in the body, known as pharmacokinetics.

  • Who can participate: Adults aged 18 to 55 years with relapsing forms of MS and a recent history of relapses or active brain lesions can participate. Participants must weigh between 45 to 120 kg and have a body mass index between 18.0 to 35.0 kg/m2. They should not have primary progressive MS or other medical conditions that affect study participation.
  • Study details: Participants will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will include regular assessments to monitor disease activity and medication effects.
  • Study timelines: The study will last 320 weeks.