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

Phase 2

Active, not recruiting

• Conditions: Multiple Sclerosis
• Interventions: Drug: placebo IV; Drug: SAR441344 IV; Drug: placebo SC; Drug: SAR441344 SC; Drug: MRI contrast-enhancing preparations

• Registration Number: NCT04879628
• Lead Sponsor: Sanofi

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-10
• Study Start: 2021-06-07
• Primary Completion: 2022-09-21
• Disposition First Submitted: 2023-09-21
• Disposition First Posted: 2023-09-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Study Completion: 2027-08-23

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous (IV) SAR441344	MRI contrast-enhancing preparations	SAR441344 IV
IV Placebo	placebo IV	Placebo IV
IV Placebo	MRI contrast-enhancing preparations	Placebo IV
Intravenous (IV) SAR441344	SAR441344 IV	SAR441344 IV
SC Placebo	placebo SC	Placebo SC
SC Placebo	MRI contrast-enhancing preparations	Placebo SC
Subcutaneous (SC) SAR441344	SAR441344 SC	SAR441344 SC
Subcutaneous (SC) SAR441344	MRI contrast-enhancing preparations	SAR441344 SC

Primary Outcome Measures

Name	Time	Method
Number of new Gadolinium (Gd)-enhancing T1-hyperintense (GdE T1) lesions	At Week 12	measured by brain magnetic resonance imaging (MRI)

Secondary Outcome Measures

Name	Time	Method
PK parameter: tmax	Until Week 316	time to Cmax
PK parameter: t1/2z	Until Week 316	elimination half-life
PK parameter: AUC0-tau	Until Week 316	area under the curve over the dosing interval
Total number of GdE T1 lesions	At Week 12	Total number of GdE T1 lesions at Week 12
Adverse events (AEs) and serious adverse events (SAEs)	Until Week 316	Number of participants with AEs and SAEs
Number of new or enlarging T2 lesions	At Week 12	measured by brain magnetic resonance imaging (MRI)
Antidrug antibodies (ADA)	Until Week 316	Number of participants with ADA
Pharmacokinetic (PK) parameters: Cmax	Until Week 316	maximum concentration

Trial Locations

Locations (38)

Investigational Site Number : 1000002; 🇧🇬 Pleven, Bulgaria

Investigational Site Number : 6430008; 🇷🇺 Tyumen, Russian Federation

Investigational Site Number : 6430001; 🇷🇺 Moscow, Russian Federation

Investigational Site Number : 7920001; 🇹🇷 Izmit, Turkey

Investigational Site Number : 8040006; 🇺🇦 Dnipro, Ukraine

Investigational Site Number : 6430003; 🇷🇺 St-Petersburg, Russian Federation

Investigational Site Number : 7920003; 🇹🇷 Istanbul, Turkey

Investigational Site Number : 8040002; 🇺🇦 Kyiv, Ukraine

Investigational Site Number : 8040005; 🇺🇦 Vinnytsia, Ukraine

Investigational Site Number : 2030004; 🇨🇿 Teplice, Czechia

Investigational Site Number : 7240002; 🇪🇸 Vigo, Spain

Investigational Site Number : 2030001; 🇨🇿 Jihlava, Czechia

Investigational Site Number : 1000003; 🇧🇬 Sofia, Bulgaria

Investigational Site Number : 1000001; 🇧🇬 Sofia, Bulgaria

Investigational Site Number : 2500006; 🇫🇷 Calais, France

Investigational Site Number : 2030005; 🇨🇿 Ostrava - Poruba, Czechia

Investigational Site Number : 2760001; 🇩🇪 Gießen, Germany

Investigational Site Number : 6430004; 🇷🇺 Saint-Petersburg, Russian Federation

Investigational Site Number : 8040004; 🇺🇦 Lviv, Ukraine

Investigational Site Number : 2760012; 🇩🇪 Leipzig, Germany

Investigational Site Number : 6430002; 🇷🇺 Kazan, Russian Federation

Investigational Site Number : 6430005; 🇷🇺 St-Petersburg, Russian Federation

Investigational Site Number : 7920004; 🇹🇷 Eskisehir, Turkey

Investigational Site Number : 8040008; 🇺🇦 Ivano-Frankivsk, Ukraine

Investigational Site Number : 6430006; 🇷🇺 Moscow, Russian Federation

Investigational Site Number : 7920002; 🇹🇷 Mersin, Turkey

Investigational Site Number : 8040003; 🇺🇦 Odesa, Ukraine

Investigational Site Number : 7240004; 🇪🇸 Barcelona, Barcelona [Barcelona], Spain

Center for Neurology and Spine Site Number : 8400007; 🇺🇸 Phoenix, Arizona, United States

University of South Florida Site Number : 8400001; 🇺🇸 Tampa, Florida, United States

Medical College of Wisconsin Site Number : 8400006; 🇺🇸 Milwaukee, Wisconsin, United States

The Neurological Institute Site Number : 8400004; 🇺🇸 Charlotte, North Carolina, United States

Investigational Site Number : 2030002; 🇨🇿 Hradec Kralove, Czechia

Investigational Site Number : 2030003; 🇨🇿 Brno, Czechia

Investigational Site Number : 1240001; 🇨🇦 Gatineau, Quebec, Canada

Investigational Site Number : 2760004; 🇩🇪 Münster, Germany

Investigational Site Number : 6430007; 🇷🇺 Moscow, Russian Federation

Investigational Site Number : 8040010; 🇺🇦 Dnipro, Ukraine