This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04879628
Recruitment Status : Active, not recruiting
First Posted : May 10, 2021
Last Update Posted : February 21, 2024
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: SAR441344 IV Drug: placebo IV Drug: SAR441344 SC Drug: placebo SC Drug: MRI contrast-enhancing preparations Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Part A is a 12-week, double-blind, placebo-controlled part; Part B is an open-label SAR441344 treatment part.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 7, 2021
Actual Primary Completion Date : September 21, 2022
Estimated Study Completion Date : August 23, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Intravenous (IV) SAR441344
SAR441344 IV
 Drug: SAR441344 IV
Pharmaceutical form: Solution Route of administration: IV infusion

Drug: MRI contrast-enhancing preparations
gadolinium compound, including but not limited to Magnevist, Multihance, Prohance, or Elucirem
Placebo Comparator: IV Placebo
Placebo IV
 Drug: placebo IV
Pharmaceutical form: Solution Route of administration: IV infusion

Drug: MRI contrast-enhancing preparations
gadolinium compound, including but not limited to Magnevist, Multihance, Prohance, or Elucirem
Experimental: Subcutaneous (SC) SAR441344
SAR441344 SC
 Drug: SAR441344 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
Placebo Comparator: SC Placebo
Placebo SC
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of new Gadolinium (Gd)-enhancing T1-hyperintense (GdE T1) lesions [ Time Frame: At Week 12 ]
    measured by brain magnetic resonance imaging (MRI)


Secondary Outcome Measures :
  1. Number of new or enlarging T2 lesions [ Time Frame: At Week 12 ]
    measured by brain magnetic resonance imaging (MRI)

  2. Total number of GdE T1 lesions [ Time Frame: At Week 12 ]
    Total number of GdE T1 lesions at Week 12

  3. Adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Until Week 316 ]
    Number of participants with AEs and SAEs

  4. Antidrug antibodies (ADA) [ Time Frame: Until Week 316 ]
    Number of participants with ADA

  5. Pharmacokinetic (PK) parameters: Cmax [ Time Frame: Until Week 316 ]
    maximum concentration

  6. PK parameter: tmax [ Time Frame: Until Week 316 ]
    time to Cmax

  7. PK parameter: AUC0-tau [ Time Frame: Until Week 316 ]
    area under the curve over the dosing interval

  8. PK parameter: t1/2z [ Time Frame: Until Week 316 ]
    elimination half-life


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04879628


Locations
Show Show 38 study locations
Sponsors and Collaborators
Sanofi
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04879628    
Other Study ID Numbers: ACT16877
U1111-1260-3962 ( Registry Identifier: ICTRP )
2020-004785-19 ( EudraCT Number )
First Posted: May 10, 2021    Key Record Dates
Last Update Posted: February 21, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases