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Bruton's Tyrosine Kinase (BTK) Inhibitor

Tolebrutinib for Multiple Sclerosis

Phase 2

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

The participant is receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to final follow-up visit ( month 60 plus 8 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug for safety and effectiveness in treating RMS.

Who is the study for?

This trial is for people with relapsing multiple sclerosis who completed the DRI15928 study. Women must use effective birth control, and menopause should be confirmed by specific criteria. Participants need to consent in writing before any procedures.

What is being tested?

The long-term safety and effectiveness of Tolebrutinib (SAR442168) are being tested on participants with relapsing multiple sclerosis, focusing on how well it controls disease activity through clinical assessments and imaging techniques.

What are the potential side effects?

While not explicitly listed here, potential side effects may include those typical of MS treatments such as flu-like symptoms, injection site reactions, allergic reactions, or liver problems. Specific side effects will be monitored throughout the trial.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am taking medication that strongly affects liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to final follow-up visit ( month 60 plus 8 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to final follow-up visit ( month 60 plus 8 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to final follow-up visit ( month 60 plus 8 weeks) 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 Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of Participants with Potentially Clinically Significant Abnormalities

Secondary study objectives

Change in Expanded Disability Status Scale (EDSS) from baseline over time

Number of new gadolinium (Gd)-enhancing T1 hyperintense lesions

Number of new or enlarging T2 lesions

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SAR442168Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tolebrutinib

2020

Completed Phase 3

~3110

0 / 1Eligibility criteria met