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

Primary Purpose

Multiple Sclerosis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SAR441344 IV
placebo IV
SAR441344 SC
placebo SC
MRI contrast-enhancing preparations
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number :8400007
  • Investigational Site Number :8400001
  • Investigational Site Number :8400004
  • Investigational Site Number :8400002
  • Investigational Site Number :8400003
  • Investigational Site Number :8400006
  • Investigational Site Number :1000002
  • Investigational Site Number :1000003
  • Investigational Site Number :1000001
  • Investigational Site Number :1240001
  • Investigational Site Number :2030003
  • Investigational Site Number :2030002
  • Investigational Site Number :2030001
  • Investigational Site Number :2030005
  • Investigational Site Number :2030004
  • Investigational Site Number :2500007
  • Investigational Site Number :2500003
  • Investigational Site Number :2500006
  • Investigational Site Number :2500002
  • Investigational Site Number :2500004
  • Investigational Site Number :2760003
  • Investigational Site Number :2760001
  • Investigational Site Number :2760012
  • Investigational Site Number :2760004
  • Investigational Site Number :2760011
  • Investigational Site Number :2760005
  • Investigational Site Number :6430002
  • Investigational Site Number :6430007
  • Investigational Site Number :6430006
  • Investigational Site Number :6430001
  • Investigational Site Number :6430004
  • Investigational Site Number :6430003
  • Investigational Site Number :6430005
  • Investigational Site Number :6430008
  • Investigational Site Number :7240004
  • Investigational Site Number :7240003
  • Investigational Site Number :7240002
  • Investigational Site Number :7920004
  • Investigational Site Number :7920003
  • Investigational Site Number :7920001
  • Investigational Site Number :7920002
  • Investigational Site Number :8040006
  • Investigational Site Number :8040010
  • Investigational Site Number :8040008
  • Investigational Site Number :8040002
  • Investigational Site Number :8040004
  • Investigational Site Number :8040003
  • Investigational Site Number :8040005

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

IV SAR441344

IV Placebo

SC SAR441344

SC Placebo

Arm Description

SAR441344 IV

Placebo IV

SAR441344 SC

Placebo SC

Outcomes

Primary Outcome Measures

Number of new Gadolinium (Gd)-enhancing T1-hyperintense (GdE T1) lesions
measured by brain magnetic resonance imaging (MRI)

Secondary Outcome Measures

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

Full Information

First Posted
May 6, 2021
Last Updated
September 21, 2023
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT04879628
Brief Title
Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
September 21, 2022 (Actual)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 176 weeks in both parts of the study, including 4 weeks of screening, at maximum 148 weeks of treatment and 24 weeks of follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Part A is a 12-week, double-blind, placebo-controlled part; Part B is an open-label SAR441344 treatment part.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV SAR441344
Arm Type
Experimental
Arm Description
SAR441344 IV
Arm Title
IV Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo IV
Arm Title
SC SAR441344
Arm Type
Experimental
Arm Description
SAR441344 SC
Arm Title
SC Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo SC
Intervention Type
Drug
Intervention Name(s)
SAR441344 IV
Intervention Description
Pharmaceutical form: Solution Route of administration: IV infusion
Intervention Type
Drug
Intervention Name(s)
placebo IV
Intervention Description
Pharmaceutical form: Solution Route of administration: IV infusion
Intervention Type
Drug
Intervention Name(s)
SAR441344 SC
Intervention Description
Pharmaceutical form: Solution Route of administration: SC injection
Intervention Type
Drug
Intervention Name(s)
placebo SC
Intervention Description
Pharmaceutical form: Solution Route of administration: SC injection
Intervention Type
Drug
Intervention Name(s)
MRI contrast-enhancing preparations
Intervention Description
Pharmaceutical form: Solution Route of administration: IV injection
Primary Outcome Measure Information:
Title
Number of new Gadolinium (Gd)-enhancing T1-hyperintense (GdE T1) lesions
Description
measured by brain magnetic resonance imaging (MRI)
Time Frame
At Week 12
Secondary Outcome Measure Information:
Title
Number of new or enlarging T2 lesions
Description
measured by brain magnetic resonance imaging (MRI)
Time Frame
At Week 12
Title
Total number of GdE T1 lesions
Description
Total number of GdE T1 lesions at Week 12
Time Frame
At Week 12
Title
Adverse events (AEs) and serious adverse events (SAEs)
Description
Number of participants with AEs and SAEs
Time Frame
Until Week 172
Title
Antidrug antibodies (ADA)
Description
Number of participants with ADA
Time Frame
Until Week 172
Title
Pharmacokinetic (PK) parameters: Cmax
Description
maximum concentration
Time Frame
Until Week 172
Title
PK parameter: tmax
Description
time to Cmax
Time Frame
Until Week 172
Title
PK parameter: AUC0-tau
Description
area under the curve over the dosing interval
Time Frame
Until Week 172
Title
PK parameter: t1/2z
Description
elimination half-life
Time Frame
Until Week 172

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number :8400007
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Investigational Site Number :8400001
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Investigational Site Number :8400004
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Investigational Site Number :8400002
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Investigational Site Number :8400003
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Investigational Site Number :8400006
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Investigational Site Number :1000002
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Investigational Site Number :1000003
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Investigational Site Number :1000001
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Investigational Site Number :1240001
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 1W2
Country
Canada
Facility Name
Investigational Site Number :2030003
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
Investigational Site Number :2030002
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Investigational Site Number :2030001
City
Jihlava
ZIP/Postal Code
58633
Country
Czechia
Facility Name
Investigational Site Number :2030005
City
Ostrava - Poruba
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Investigational Site Number :2030004
City
Teplice
ZIP/Postal Code
415 29
Country
Czechia
Facility Name
Investigational Site Number :2500007
City
Ars-Laquenexy
ZIP/Postal Code
57085
Country
France
Facility Name
Investigational Site Number :2500003
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Investigational Site Number :2500006
City
Calais
ZIP/Postal Code
62107
Country
France
Facility Name
Investigational Site Number :2500002
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Investigational Site Number :2500004
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
Investigational Site Number :2760003
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Investigational Site Number :2760001
City
Gießen
ZIP/Postal Code
35385
Country
Germany
Facility Name
Investigational Site Number :2760012
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Investigational Site Number :2760004
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Investigational Site Number :2760011
City
Sande
ZIP/Postal Code
26452
Country
Germany
Facility Name
Investigational Site Number :2760005
City
Würzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Investigational Site Number :6430002
City
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
Investigational Site Number :6430007
City
Moscow
ZIP/Postal Code
117556
Country
Russian Federation
Facility Name
Investigational Site Number :6430006
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Investigational Site Number :6430001
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
Investigational Site Number :6430004
City
Saint-Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Investigational Site Number :6430003
City
St-Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Investigational Site Number :6430005
City
St-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Investigational Site Number :6430008
City
Tyumen
ZIP/Postal Code
625000
Country
Russian Federation
Facility Name
Investigational Site Number :7240004
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Facility Name
Investigational Site Number :7240003
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Investigational Site Number :7240002
City
Vigo
State/Province
Pontevedra [Pontevedra]
ZIP/Postal Code
36312
Country
Spain
Facility Name
Investigational Site Number :7920004
City
Eskisehir
Country
Turkey
Facility Name
Investigational Site Number :7920003
City
Istanbul
Country
Turkey
Facility Name
Investigational Site Number :7920001
City
Izmit
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Investigational Site Number :7920002
City
Mersin
ZIP/Postal Code
33070
Country
Turkey
Facility Name
Investigational Site Number :8040006
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Investigational Site Number :8040010
City
Dnipro
ZIP/Postal Code
49069
Country
Ukraine
Facility Name
Investigational Site Number :8040008
City
Ivano-Frankivsk
ZIP/Postal Code
76493
Country
Ukraine
Facility Name
Investigational Site Number :8040002
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
Investigational Site Number :8040004
City
Lviv
ZIP/Postal Code
79013
Country
Ukraine
Facility Name
Investigational Site Number :8040003
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Investigational Site Number :8040005
City
Vinnytsia
ZIP/Postal Code
21050
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

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

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