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

NCT04879628 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2025-09-30

Study results available
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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

Conditions

Interventions

DRUG

SAR441344 IV

Pharmaceutical form: Solution Route of administration: IV infusion

DRUG

placebo IV

Pharmaceutical form: Solution Route of administration: IV infusion

DRUG

SAR441344 SC

Pharmaceutical form: Solution Route of administration: SC injection

DRUG

placebo SC

Pharmaceutical form: Solution Route of administration: SC injection

DRUG

MRI contrast-enhancing preparations

gadolinium compound, including but not limited to Magnevist, Multihance, Prohance, or Elucirem

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-07
Primary Completion
2022-09-21
Completion
2027-08-23
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • Czechia
  • France
  • Germany
  • Russia
  • Spain
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04879628 on ClinicalTrials.gov