Multiple Sclerosis Clinical Trial

Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis

Summary

Primary Objective:

To determine the dose-response relationship for SAR442168 to reduce the number of new active brain lesions.

Secondary Objectives:

To evaluate efficacy of SAR442168 on disease activity as assessed by imaging measures.
To evaluate the safety and tolerability of SAR442168.

View Full Description

Full Description

The total study duration was 24 weeks which included a screening period of 4 weeks, a treatment period of 16 weeks, and a follow-up period of up to 4 weeks. Participants who completed the Week 16 visit were proposed to be enrolled in a long-term extension safety and efficacy study to assess safety, tolerability and efficacy of SAR442168.

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
Participant was diagnosed with relapsing multiple sclerosis (RMS) according to the 2017 revision of the McDonald diagnostic criteria.
Participant must had at least 1 documented relapse within the previous year, OR greater than or equal to (>=) 2 documented relapses within the previous 2 years, OR >=1 active Gadolinium (Gd) enhancing brain lesion on an MRI scan in the past 6 months and prior to screening.
A female participant must had used a double contraception method including a highly effective method of birth control from inclusion and up to 2 months after the last study dose, except if she had undergone sterilization at least 3 months earlier or was postmenopausal. Menopause was defined as being amenorrheic for >=12 months with serum follicle-stimulating hormone (FSH) level greater than (>) 30 International Units per liters.
Male participants, whose partners were of childbearing potential (including breastfeeding women), must had accepted to use, during sexual intercourse, a double contraceptive method according to the following algorithm: (condom) plus (intrauterine device or hormonal contraceptive) from inclusion up to 3 months after the last dose.
Male participants whose partners were pregnant must had used, during sexual intercourse, a condom from inclusion up to 3 months after the last dose.
Male participants had agreed not to donate sperm from the inclusion up to 3 months after the last dose.
Participant had given written informed consent prior to undertaking any study-related procedure.

Exclusion criteria:

The participant had been diagnosed with primary progressive multiple sclerosis according to the 2017 revision of the McDonald diagnostic criteria or with non relapsing secondary progressive multiple sclerosis.
Requirement for concomitant treatment that could bias the primary evaluation.
Contraindication for MRI.
Contraindications to use MRI Gd contrast-enhancing preparations.
History of infection with the human immunodeficiency virus (HIV).
History of active or latent tuberculosis.
Any other active infections that would adversely affect participation or investigational medicinal product administration in this study, as judged by the Investigator.
Presence of any screening laboratory or electrocardiogram values outside normal limits that were considered in the Investigator's judgment to be clinically significant.
Presence of liver injury.
At screening, the participant was positive for hepatitis B surface antigen and/or hepatitis B core antibody and/or was positive for hepatitis C antibody.
Bleeding disorder or known platelet dysfunction at any time prior to screening visit.
Participant had received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) within 2 months before first treatment visit.
Participant was receiving strong inducers or inhibitors of cytochrome P450 3A (CYP3A) or CYP2C8 hepatic enzymes.
Participant was receiving anticoagulant/antiplatelet therapies.
Participant had taken other investigational drugs within 3 months or 5 half lives, whichever was longer, before screening visit.
Participant had an Expanded Disability Status Scale score >5.5 at first screening visit.
Participant had a relapse in the 30 days prior to randomization.
Participant was pregnant or a breastfeeding woman.
History or presence of significant other concomitant illness.
The participant had received medications/treatments for multiple sclerosis within a specified time frame.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

130

Study ID:

NCT03889639

Recruitment Status:

Completed

Sponsor:

Sanofi

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 47 Locations for this study

See Locations Near You

Investigational Site Number 8400005
Cullman Alabama, 35058, United States
Investigational Site Number 8400002
Maitland Florida, 32761, United States
Investigational Site Number 8400004
Sunrise Florida, 33351, United States
Investigational Site Number 8400009
Tampa Florida, 33612, United States
Investigational Site Number 8400007
Savannah Georgia, 31406, United States
Investigational Site Number 8400001
Northbrook Illinois, 60062, United States
Investigational Site Number 8400008
Dayton Ohio, 45417, United States
Investigational Site Number 8400006
Westerville Ohio, 43081, United States
Investigational Site Number 8400003
Knoxville Tennessee, 37922, United States
Investigational Site Number 1240002
Gatineau , J8Y 1, Canada
Investigational Site Number 1240001
Greenfield Park , J4V 2, Canada
Investigational Site Number 1240003
Vancouver , V6T 2, Canada
Investigational Site Number 2030007
Brno , 62500, Czechia
Investigational Site Number 2030004
Hradec Kralove , 50005, Czechia
Investigational Site Number 2030003
Jihlava , 58633, Czechia
Investigational Site Number 2030005
Ostrava - Poruba , 70852, Czechia
Investigational Site Number 2030006
Pardubice , 53203, Czechia
Investigational Site Number 2030001
Praha 2 , 12808, Czechia
Investigational Site Number 2030002
Praha 5 - Motol , 15006, Czechia
Investigational Site Number 2330001
Tallinn , 11315, Estonia
Investigational Site Number 2500004
Nancy Cedex , 54035, France
Investigational Site Number 2500001
Nantes Cedex 1 , 44093, France
Investigational Site Number 2500002
Strasbourg Cedex , 67098, France
Investigational Site Number 2500003
Toulouse Cedex 9 , 31059, France
Investigational Site Number 5280001
Amsterdam , 1081 , Netherlands
Investigational Site Number 5280002
Sittard-Geleen , 6162 , Netherlands
Investigational Site Number 6430006
Kazan , 42002, Russian Federation
Investigational Site Number 6430003
Moscow , 12536, Russian Federation
Investigational Site Number 6430002
Moscow , 12701, Russian Federation
Investigational Site Number 6430001
Saint-Petersburg , 19711, Russian Federation
Investigational Site Number 6430005
St-Petersburg , 19404, Russian Federation
Investigational Site Number 6430004
St-Petersburg , 19702, Russian Federation
Investigational Site Number 6430007
Tyumen , 62500, Russian Federation
Investigational Site Number 7030001
Bratislava , 82606, Slovakia
Investigational Site Number 7030002
Martin , 03659, Slovakia
Investigational Site Number 7240006
Barakaldo , 48903, Spain
Investigational Site Number 7240002
Barcelona , 08035, Spain
Investigational Site Number 7240001
Madrid , 28007, Spain
Investigational Site Number 7240004
Murcia , 30120, Spain
Investigational Site Number 7240005
Salt , 17190, Spain
Investigational Site Number 7240003
Sevilla , 41071, Spain
Investigational Site Number 8040002
Chernivtsi , 58018, Ukraine
Investigational Site Number 8040005
Dnipro , 49005, Ukraine
Investigational Site Number 8040001
Lviv , 79010, Ukraine
Investigational Site Number 8040006
Lviv , 79013, Ukraine
Investigational Site Number 8040009
Odesa , 65025, Ukraine
Investigational Site Number 8040003
Vinnytsya , 21005, Ukraine
Investigational Site Number 8040007
Zhytomyr , 10002, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 2

Estimated Enrollment:

130

Study ID:

NCT03889639

Recruitment Status:

Completed

Sponsor:


Sanofi

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.