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

Relapsing Multiple Sclerosis Clinical Trial

Official title:

Long-term Extension Safety and Efficacy Study of SAR442168 in Participants With Relapsing Multiple Sclerosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03996291
• Other study ID #: LTS16004
• Secondary ID: 2018-004731-76U1
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 23, 2019
• Est. completion date: November 29, 2024

Study information

• Verified date: April 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

To determine the long-term safety and tolerability of SAR442168 in RMS participants

Secondary Objective:

To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging methods

Description:

Approximately 62 months including the 8 weeks post-treatment visit

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: November 29, 2024
• Est. primary completion date: November 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Tolebrutinib
Pharmaceutical form: Film coated tablet Route of administration: Oral

Locations

Country	Name	City	State
Canada	Investigational Site Number 1240001	Greenfield Park
Canada	Investigational Site Number 1240003	Vancouver
Czechia	Investigational Site Number 2030007	Brno
Czechia	Investigational Site Number 2030004	Hradec Kralove
Czechia	Investigational Site Number 2030003	Jihlava
Czechia	Investigational Site Number 2030005	Ostrava - Poruba
Czechia	Investigational Site Number 2030006	Pardubice
Czechia	Investigational Site Number 2030001	Praha 2
Czechia	Investigational Site Number 2030002	Praha 5 - Motol
Estonia	Investigational Site Number 2330001	Tallinn
France	Investigational Site Number 2500004	Nancy Cedex
Netherlands	Investigational Site Number 5280001	Amsterdam
Russian Federation	Investigational Site Number 6430006	Kazan
Russian Federation	Investigational Site Number 6430003	Moscow
Russian Federation	Investigational Site Number 6430001	Saint-Petersburg
Russian Federation	Investigational Site Number 6430005	St-Petersburg
Russian Federation	Investigational Site Number 6430007	Tyumen
Spain	Investigational Site Number 7240002	Barcelona
Spain	Investigational Site Number 7240001	Madrid
Spain	Investigational Site Number 7240004	Murcia
Spain	Investigational Site Number 7240005	Salt
Spain	Investigational Site Number 7240003	Sevilla
Ukraine	Investigational Site Number 8040002	Chernivtsi
Ukraine	Investigational Site Number 8040005	Dnipro
Ukraine	Investigational Site Number 8040001	Lviv
Ukraine	Investigational Site Number 8040006	Lviv
Ukraine	Investigational Site Number 8040009	Odesa
Ukraine	Investigational Site Number 8040003	Vinnytsya
Ukraine	Investigational Site Number 8040007	Zhytomyr
United States	Investigational Site Number 8400005	Cullman	Alabama
United States	Investigational Site Number 8400008	Dayton	Ohio
United States	Investigational Site Number 8400003	Knoxville	Tennessee
United States	Investigational Site Number 8400002	Maitland	Florida
United States	Investigational Site Number 8400001	Northbrook	Illinois
United States	Investigational Site Number 8400007	Savannah	Georgia
United States	Investigational Site Number 8400009	Tampa	Florida
United States	Investigational Site Number 8400006	Westerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline to final follow-up visit ( Month 60 plus 8 weeks)
Primary	Number of Participants with Potentially Clinically Significant Abnormalities	Potentially clinically significant abnormalities (PCSAs) determined by laboratory tests, electrocardiogram (ECG), or vital signs during the study period.	Baseline to final follow-up visit ( Month 60 plus 8 weeks)
Secondary	Number of new gadolinium (Gd)-enhancing T1 hyperintense lesions	New gadolinium (Gd)-enhancing T1 hyperintense lesions determined by brain Magnetic Resonance Imaging (MRI)	Baseline to final follow-up visit ( Month 60 plus 8 weeks)
Secondary	Number of new or enlarging T2 lesions	T2 lesions, a marker of inflammatory activity and brain tissue destruction in RMS will be evaluated by MRI	Baseline to final follow-up visit ( Month 60 plus 8 weeks)
Secondary	Total number of Gd-enhancing T1-hyperintense lesions	Total number of Gd-enhancing T1-hyperintense lesions	Baseline to final follow-up visit ( Month 60 plus 8 weeks)
Secondary	Number of participants wih relapse (Annualized Relapse rate)	Annualized Relapse rate is defined as the number of participants with relapse during the study period.	Baseline to Month 60
Secondary	Change in Expanded Disability Status Scale (EDSS) from baseline over time	Standard EDSS assessments of neurological symptoms in each of 7 functional domains (visual, brainstem, pyramidal [motor], cerebellar [coordination], sensory, cerebral and bowel/bladder) will be performed. Ambulation will also be scored as part of the evaluation.	Baseline to final follow-up visit ( Month 60 plus 8 weeks)