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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04879628
• Other study ID #: ACT16877
• Secondary ID: U1111-1260-39622
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 7, 2021
• Est. completion date: August 23, 2027

Study information

• Verified date: February 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 129
• Est. completion date: August 23, 2027
• Est. primary completion date: September 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• 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

Country	Name	City	State
Bulgaria	Investigational Site Number : 1000002	Pleven
Bulgaria	Investigational Site Number : 1000001	Sofia
Bulgaria	Investigational Site Number : 1000003	Sofia
Canada	Investigational Site Number : 1240001	Gatineau	Quebec
Czechia	Investigational Site Number : 2030003	Brno
Czechia	Investigational Site Number : 2030002	Hradec Kralove
Czechia	Investigational Site Number : 2030001	Jihlava
Czechia	Investigational Site Number : 2030005	Ostrava - Poruba
Czechia	Investigational Site Number : 2030004	Teplice
France	Investigational Site Number : 2500006	Calais
Germany	Investigational Site Number : 2760001	Gießen
Germany	Investigational Site Number : 2760012	Leipzig
Germany	Investigational Site Number : 2760004	Münster
Russian Federation	Investigational Site Number : 6430002	Kazan
Russian Federation	Investigational Site Number : 6430001	Moscow
Russian Federation	Investigational Site Number : 6430006	Moscow
Russian Federation	Investigational Site Number : 6430007	Moscow
Russian Federation	Investigational Site Number : 6430004	Saint-Petersburg
Russian Federation	Investigational Site Number : 6430003	St-Petersburg
Russian Federation	Investigational Site Number : 6430005	St-Petersburg
Russian Federation	Investigational Site Number : 6430008	Tyumen
Spain	Investigational Site Number : 7240004	Barcelona	Barcelona [Barcelona]
Spain	Investigational Site Number : 7240002	Vigo
Turkey	Investigational Site Number : 7920004	Eskisehir
Turkey	Investigational Site Number : 7920003	Istanbul
Turkey	Investigational Site Number : 7920001	Izmit
Turkey	Investigational Site Number : 7920002	Mersin
Ukraine	Investigational Site Number : 8040006	Dnipro
Ukraine	Investigational Site Number : 8040010	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
United States	The Neurological Institute Site Number : 8400004	Charlotte	North Carolina
United States	Medical College of Wisconsin Site Number : 8400006	Milwaukee	Wisconsin
United States	Center for Neurology and Spine Site Number : 8400007	Phoenix	Arizona
United States	University of South Florida Site Number : 8400001	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  France,  Germany,  Russian Federation,  Spain,  Turkey,  Ukraine, 

Outcome

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