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

Sanofi

Status and phase: Active, not recruiting; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: SAR441344 SC; Drug: SAR441344 IV; Drug: placebo IV; Drug: MRI contrast-enhancing preparations; Drug: placebo SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04879628

U1111-1260-3962 (Registry Identifier)

2020-004785-19 (EudraCT Number)

2024-513527-17-00 (Registry Identifier)

ACT16877

Details and patient eligibility

About

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

Full description

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.

Enrollment: 129 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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129 participants in 4 patient groups, including a placebo group

Intravenous (IV) SAR441344

Experimental group

Description:

SAR441344 IV

Treatment:

Drug: MRI contrast-enhancing preparations

Drug: SAR441344 IV

IV Placebo

Placebo Comparator group

Description:

Placebo IV

Treatment:

Drug: MRI contrast-enhancing preparations

Drug: placebo IV

Subcutaneous (SC) SAR441344

Experimental group

Description:

SAR441344 SC

Treatment:

Drug: MRI contrast-enhancing preparations

Drug: SAR441344 SC

SC Placebo

Placebo Comparator group

Description:

Placebo SC

Treatment:

Drug: MRI contrast-enhancing preparations

Drug: placebo SC