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Bruton's Tyrosine Kinase (BTK) Inhibitor

Tolebrutinib for Multiple Sclerosis

Phase 3
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Participant is at risk for or has a persistent chronic, active, or recurring systemic infection
Abnormal liver function tests
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until the end of study approximately 3 years per participant
Awards & highlights

Summary

This trial is studying the long-term safety and tolerability of a drug called tolebrutinib in adults with certain types of multiple sclerosis. Participants in this trial were previously enrolled in other studies

Who is the study for?
This trial is for adults with Relapsing Multiple Sclerosis (RMS), Primary Progressive MS (PPMS), or Non-Relapsing Secondary Progressive MS (NRSPMS) who were part of earlier Phase 2b or Phase 3 tolebrutinib studies. It's not open to new patients; only those who completed previous trials on the medication, including during emergencies.
What is being tested?
The study is testing the long-term safety and tolerability of a drug called Tolebrutinib in people with different types of Multiple Sclerosis. Participants from prior related studies continue treatment to see how they do over time. Some may receive Teriflunomide or a placebo as comparisons.
What are the potential side effects?
Tolebrutinib might cause liver issues, infections due to weakened immune responses, high blood pressure, and possibly other unknown long-term side effects since this study aims to discover them.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am at risk for or currently have a long-lasting infection.
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My liver tests are not normal.
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I do not have any liver diseases like cirrhosis or chronic liver disease.
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I have a bleeding disorder or a history of significant bleeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until the end of study approximately 3 years per participant
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until the end of study approximately 3 years per participant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Potentially clinically significant abnormalities (PCSAs)
Secondary outcome measures
Annualized Relapse Rate (ARR) for RMS only
Time to onset of 6-month confirmed disability worsening (CDW for RMS) or confirmed disability progression (CDP for PPMS and NRSPMS) for participants from pivotal studies

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TolebrutinibExperimental Treatment2 Interventions
* Participants will receive OL tolebrunitib 60 mg once daily. * RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment as per their randomization from the parent study.
Group II: TeriflunomideActive Control2 Interventions
* participants will receive teriflunomide 14 mg daily * RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment (either tolebrutinib or teriflunomide) as per their randomization from the parent study. If unblinded to teriflunomide parent study treatment assignment, these RMS participants will continue teriflunomide in the LTS17043 study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Tolebrutinib
2020
Completed Phase 1
~110

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Who is running the clinical trial?

SanofiLead Sponsor
2,187 Previous Clinical Trials
3,977,278 Total Patients Enrolled
41 Trials studying Multiple Sclerosis
14,263 Patients Enrolled for Multiple Sclerosis
~1667 spots leftby Apr 2029
Unbiased ResultsWe believe in providing patients with all the options.
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