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Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis
Sponsor: Sanofi
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
Conditions
Interventions
SAR441344 IV
Pharmaceutical form: Solution Route of administration: IV infusion
placebo IV
Pharmaceutical form: Solution Route of administration: IV infusion
SAR441344 SC
Pharmaceutical form: Solution Route of administration: SC injection
placebo SC
Pharmaceutical form: Solution Route of administration: SC injection
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