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

Phase 2

Completed

• Conditions: Relapsing Multiple Sclerosis
• Interventions: Drug: Tolebrutinib

• Registration Number: NCT03996291
• Lead Sponsor: Sanofi

Brief 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

Detailed Description

Approximately 62 months including the 8 weeks post-treatment visit

Study Timeline

• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-06-20
• Study First Posted: 2019-06-24
• Study Start: 2019-09-23
• Primary Completion: 2024-11-26
• Study Completion: 2024-11-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SAR442168	Tolebrutinib	SAR442168 : Experimental - Part A: Double-blind period of continued treatment with the respective SAR442168 dose administered in the DRI15928 study until selection of Phase 3 dose. Part B: Open-label period of a single-group treatment with SAR442168 selected Phase 3 dose of 60 mg. All participants will be switched to this 60 mg dose.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline to final follow-up visit ( Month 60 plus 8 weeks)	Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants with Potentially Clinically Significant Abnormalities	Baseline to final follow-up visit ( Month 60 plus 8 weeks)	Potentially clinically significant abnormalities (PCSAs) determined by laboratory tests, electrocardiogram (ECG), or vital signs during the study period.

Secondary Outcome Measures

Name	Time	Method
Number of new gadolinium (Gd)-enhancing T1 hyperintense lesions	Baseline to final follow-up visit ( Month 60 plus 8 weeks)	New gadolinium (Gd)-enhancing T1 hyperintense lesions determined by brain Magnetic Resonance Imaging (MRI)
Number of new or enlarging T2 lesions	Baseline to final follow-up visit ( Month 60 plus 8 weeks)	T2 lesions, a marker of inflammatory activity and brain tissue destruction in RMS will be evaluated by MRI
Number of participants wih relapse (Annualized Relapse rate)	Baseline to Month 60	Annualized Relapse rate is defined as the number of participants with relapse during the study period.
Total number of Gd-enhancing T1-hyperintense lesions	Baseline to final follow-up visit ( Month 60 plus 8 weeks)	Total number of Gd-enhancing T1-hyperintense lesions
Change in Expanded Disability Status Scale (EDSS) from baseline over time	Baseline to final follow-up visit ( Month 60 plus 8 weeks)	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.

Trial Locations

Locations (37)

North Central Neurology Associates, PC Site Number : 8400005; 🇺🇸 Cullman, Alabama, United States

Neurology Associates, PA Site Number : 8400002; 🇺🇸 Maitland, Florida, United States

University of South Florida Site Number : 8400009; 🇺🇸 Tampa, Florida, United States

Velocity Clinical Research Site Number : 8400007; 🇺🇸 Savannah, Georgia, United States

Consultants In Neurology Site Number : 8400001; 🇺🇸 Northbrook, Illinois, United States

UC Health, LLC Site Number : 8400008; 🇺🇸 Dayton, Ohio, United States

MDH Research LLC Site Number : 8400006; 🇺🇸 Westerville, Ohio, United States

Neurology PC Site Number : 8400003; 🇺🇸 Knoxville, Tennessee, United States

Investigational Site Number : 1240003; 🇨🇦 Vancouver, British Columbia, Canada

Investigational Site Number : 1240001; 🇨🇦 Greenfield Park, Quebec, Canada

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, Czechia

Investigational Site Number : 2330001; 🇪🇪 Tallinn, Estonia

Investigational Site Number : 2500004; 🇫🇷 Nancy, France

Investigational Site Number : 5280001; 🇳🇱 Amsterdam, Netherlands

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, Russian Federation

Investigational Site Number : 7240003; 🇪🇸 Sevilla, Andalucia, Spain

Investigational Site Number : 7240002; 🇪🇸 Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240005; 🇪🇸 Salt, Girona [Gerona], Spain

Investigational Site Number : 7240001; 🇪🇸 Madrid, Spain

Investigational Site Number : 7240004; 🇪🇸 Murcia, Spain

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, Ukraine