Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04879628
PHASE2

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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

Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

129

Start Date

2021-06-07

Completion Date

2027-08-23

Last Updated

2025-09-30

Healthy Volunteers

No

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

Locations (37)

Center for Neurology and Spine- Site Number : 8400007

Phoenix, Arizona, United States

University of South Florida Site Number : 8400001

Tampa, Florida, United States

The Neurological Institute Site Number : 8400004

Charlotte, North Carolina, United States

Medical College of Wisconsin- Site Number : 8400006

Milwaukee, Wisconsin, United States

Investigational Site Number : 1000002

Pleven, Bulgaria

Investigational Site Number : 1000003

Sofia, Bulgaria

Investigational Site Number : 1000001

Sofia, Bulgaria

Investigational Site Number : 1240001

Gatineau, Quebec, Canada

Investigational Site Number : 2030003

Brno, Czechia

Investigational Site Number : 2030002

Hradec Králové, Czechia

Investigational Site Number : 2030001

Jihlava, Czechia

Investigational Site Number : 2030005

Ostrava - Poruba, Czechia

Investigational Site Number : 2030004

Teplice, Czechia

Investigational Site Number : 2500006

Calais, France

Investigational Site Number : 2760012

Leipzig, Germany

Investigational Site Number : 2760004

Münster, Germany

Investigational Site Number : 6430002

Kazan', Russia

Investigational Site Number : 6430007

Moscow, Russia

Investigational Site Number : 6430006

Moscow, Russia

Investigational Site Number : 6430001

Moscow, Russia

Investigational Site Number : 6430003

Saint Petersburg, Russia

Investigational Site Number : 6430005

Saint Petersburg, Russia

Investigational Site Number : 6430004

Saint Petersburg, Russia

Investigational Site Number : 6430008

Tyumen, Russia

Investigational Site Number : 7240004

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240002

Vigo, Spain

Investigational Site Number : 7920004

Eskişehir, Turkey (Türkiye)

Investigational Site Number : 7920003

Istanbul, Turkey (Türkiye)

Investigational Site Number : 7920001

İzmit, Turkey (Türkiye)

Investigational Site Number : 7920002

Mersin, Turkey (Türkiye)

Investigational Site Number : 8040010

Dnipro, Ukraine

Investigational Site Number : 8040006

Dnipro, Ukraine

Investigational Site Number : 8040008

Ivano-Frankivsk, Ukraine

Investigational Site Number : 8040002

Kyiv, Ukraine

Investigational Site Number : 8040004

Lviv, Ukraine

Investigational Site Number : 8040003

Odesa, Ukraine

Investigational Site Number : 8040005

Vinnytsia, Ukraine