Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 1 May 2023
• Main ID: NCT03996291
• Date of registration: 20/06/2019
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis
• Scientific title: Long-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple Sclerosis
• Date of first enrolment: September 23, 2019
• Target sample size: 125
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03996291
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada, Czechia, Estonia, France, Netherlands, Russian Federation, Spain, Ukraine, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria:

- Participants must have completed treatment in the DRI15928 study

- Female participants must continue to use an acceptable effective contraception method
of birth control from inclusion and until the last dose of study drug, 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.

- The participant must have given written informed consent prior to undertaking any
study related procedure.

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 treatment 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.

- The participant is receiving anticoagulant/antiplatelet therapies, including:

- Acetylsalicylic acid (aspirin)

- 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 experience. The 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 procedures

- The participant is pregnant or is a breastfeeding woman.

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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing Multiple Sclerosis

Intervention(s)

Drug: Tolebrutinib

Primary Outcome(s)

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Baseline to final follow-up visit ( Month 60 plus 8 weeks)]

Number of Participants with Potentially Clinically Significant Abnormalities [Time Frame: Baseline to final follow-up visit ( Month 60 plus 8 weeks)]

Secondary Outcome(s)

Number of new gadolinium (Gd)-enhancing T1 hyperintense lesions [Time Frame: Baseline to final follow-up visit ( Month 60 plus 8 weeks)]

Total number of Gd-enhancing T1-hyperintense lesions [Time Frame: Baseline to final follow-up visit ( Month 60 plus 8 weeks)]

Change in Expanded Disability Status Scale (EDSS) from baseline over time [Time Frame: Baseline to final follow-up visit ( Month 60 plus 8 weeks)]

Number of new or enlarging T2 lesions [Time Frame: Baseline to final follow-up visit ( Month 60 plus 8 weeks)]

Number of participants wih relapse (Annualized Relapse rate) [Time Frame: Baseline to Month 60]

Secondary ID(s)

2018-004731-76

U1111-1223-4256

LTS16004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors