ong-term safety and efficacy study of SAR442168 in relapsing multiple sclerosis

Phase 1

• Conditions: Relapsing multiple sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-004731-76-ES
• Lead Sponsor: Genzyme Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-12
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 105

Inclusion Criteria

- Participants must have completed treatment in the DRI15928 study
- Female participants must continue to use 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 has undergone sterilization at least 3 months earlier or is postmenopausal. Menopause is defined as being amenorrheic for =12 months with plasma follicle stimulating hormone (FSH) level >30 UI/L.
- 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.
- The 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 105
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- The participant has a confirmed concomitant laboratory or ECG abnormality or medical condition deemed by the investigator incompatible with continuation of SAR442168 treatment.
- The participant has received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) between the last DRI15928 visit and the first treatment visit in the LTS16004 study.
- The participant has received a non-study MS disease modifying treatment between the last IMP treatment in Study DRI15928 and inclusion in Study LTS16004, which by judgement of the Investigator may add unjustified risk to switching back and continuing trreatment with SAR442168.
- Washout periods after treatment with non-study DMTs should be respected except for interferons or glatiramer acetate treatment.
- The participant is receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes.
Note: Such drugs need to be stopped at least 5 half-lives before study drug administration.
- The participant is receiving anticoagulant/antiplatelet therapies, including:
• Acetylsalicylic acid (aspirin) (if more than 81 mg/day)
• Antiplatelet drugs (eg, clopidogrel)
• Warfarin (vitamin K antagonist)
• Heparin, including low molecular weight heparin (antithrombin agents)
• Dabigatran (direct thrombin inhibitor)
• Apixaban, edoxaban, rivaroxaban (direct factor Xa inhibitors)
Note: All above drugs need to be stopped at least 5 half-lives before study drug administration except for aspirin, which needs to be stopped at least 8 days beforehand.
- Prior/concurrent clinical study experienceThe participant is taking part in another interventional clinical trial of another drug substance.
- Uncooperative behavior or any condition that could make the participant potentially non-adherent with the study procédures
- The participant is pregnant or is a breastfeeding woman.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified