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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

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.