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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

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline until the end of study approximately 3 years per participant

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Potentially clinically significant abnormalities (PCSAs)

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 3

~3110