Dose-finding study for SAR442168 in relapsing multiple sclerosis

Phase 1

Conditions: Relapsing Multiple Sclerosis
MedDRA version: 20.0 Level: PT Classification code 10067063 Term: Progressive relapsing multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2018-003927-12-SK

Lead Sponsor: Genzyme Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

- Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
- Participant must have been diagnosed with relapsing multiple sclerosis (RMS) according to the 2017 revision of the McDonald diagnostic criteria.
- Participant must have at least 1 documented relapse within the previous year, =2 documented relapses within the previous 2 years, or =1 active Gadolinium (Gd)-enhancing brain lesion on an magnetic resonance imaging (MRI) scan in the past 6 months and prior to screening.
- A female participant must use a double contraception method including a highly effective method of birth control, except if she has undergone sterilization at least 3 months earlier or is postmenopausal.
- Male participants, whose partners are of childbearing potential (including breastfeeding women), must accept 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 are pregnant must use, during sexual intercourse, a condom from inclusion up to 3 months after the last dose.
- Male participants must have agreed not to donate sperm from the inclusion up to 3 months after the last dose.
- Participant must have given written informed consent prior to undertaking any study-related procedure.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- The participant has been diagnosed with primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with non relapsing secondary progressive multiple sclerosis (SPMS).
- 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 (IMP) administration in this study, as judged by the Investigator.
- Presence of any screening laboratory or ECG values outside normal limits that are considered in the Investigator’s judgment to be clinically significant.
- Presence of liver injury.
- At screening, the participant is positive for hepatitis B surface antigen and/or hepatitis B core antibody and/or is positive for hepatitis C antibody.
- Bleeding disorder or known platelet dysfunction at any time prior to screening visit.
- Participant has 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 is receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes.
- Participant is receiving anticoagulant/antiplatelet therapies.
- Participant has taken other investigational drugs within 3 months or 5 half lives, whichever is longer, before screening visit.
- Participant has an Expanded Disability Status Scale (EDSS) score >5.5 at screening visit.
- Participant has had a relapse in the 30 days prior to randomization.
- Participant is pregnant or a breastfeeding woman.
- History or presence of significant other concomitant illness.
- The participant has received medications/treatments for MS within a specified time frame.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the dose-response relationship for SAR442168 to reduce the number of new active brain lesions;<br> Secondary Objective: - To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging measures<br> - To evaluate the safety and tolerability of SAR442168<br> ;Primary end point(s): Number of new Gd-enhancing T1 hyperintense lesions : Number of new Gd-enhancing T1 hyperintense lesions at the end of 12 weeks of SAR442168 treatment as detected by brain MRI;Timepoint(s) of evaluation of this end point: Week 12 for Arms 1-4, Week 4 and Week 16 for Arms 5-8

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1 - Number of new or enlarging T2 lesions : Number of new or enlarging T2 lesions at the end of 12 weeks of SAR442168 treatment<br> 2 - Total number of Gd-enhancing T1 hyperintense lesions : Total number of Gd-enhancing T1-hyperintense lesions at the end of 12 weeks of SAR442168 treatment<br> 3 - Adverse events : Number (n) and percentage (%) of participants experiencing an adverse event (AE)/Serious<br> Adverse Event (SAE) or potentially clinically significant abnormalities in laboratory tests, electrocardiogram (ECG), or vital signs<br> ;<br> Timepoint(s) of evaluation of this end point: 1, 2 : Week 12 for Arms 1-4, Week 4 and Week 16 for Arms 5-8<br> 3 : From baseline to the end of study (approximately 20 weeks)<br>

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