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Bruton's Tyrosine Kinase Inhibitor

Tolebrutinib for Multiple Sclerosis

Phase 2

Waitlist Available

Led By Daniel S Reich, M.D.

Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility Criteria Checklist

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

Must have

Willingness to comply with all study procedures and availability for the duration of the study

Diagnosed with multiple sclerosis according to the 2017 revision of the McDonald diagnostic criteria, with no new lesion formation by comparison of baseline MRI scan with a historical MRI scan at least 6 months prior

Timeline

Screening 3 weeks

Treatment Varies

Follow Up each patient visit

Awards & highlights

Study Summary

This trial is studying tolebrutinib to see if it can help clear inflammation in MS brain lesions.

Who is the study for?

Adults over 18 with Multiple Sclerosis (MS) who have been on anti-CD20 therapy for at least 6 months are eligible. They must have a specific type of MS lesion visible on an MRI, be vaccinated against COVID-19, and agree to not receive any other MS treatments during the trial. Women must use effective contraception, and men should ensure they do not father children or donate sperm during and after the study.Check my eligibility

What is being tested?

The trial is testing Tolebrutinib pills in two doses (60mg and 120mg) taken daily to see if it can reduce inflammation in chronic brain lesions caused by MS. Participants will either take Tolebrutinib or continue their current anti-CD20 therapy for at least 96 weeks while undergoing regular MRIs, neurological exams, blood tests, heart activity measurements, and possibly spinal taps.See study design

What are the potential side effects?

Potential side effects of Tolebrutinib may include changes in blood counts leading to increased infection risk or bleeding problems. Other possible side effects could involve liver function alterations due to drug interactions with enzymes that process medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing and able to follow all study requirements.

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I have been diagnosed with multiple sclerosis and my MRI scans show no new lesions in the last 6 months.

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I tested negative for tuberculosis.

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I am fully vaccinated against COVID-19.

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I have been on anti-CD20 antibody treatment for at least 6 months, with my last dose within the past 6 months.

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I had a 7-tesla MRI scan within the last year showing at least one specific type of brain lesion.

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I agree to use effective birth control and not donate sperm until 12 weeks after my last dose.

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I agree not to receive any anti-CD20 antibody treatments during the study.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline vs. 96 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline vs. 96 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline vs. 96 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the effects of 48 weeks of tolebrutinib 60 mg treatment on the paramagnetic rim of chron-ically inflamed white matter lesions, as seen on 7-tesla MRI.

Secondary outcome measures

To assess safety and tolerability of 96 weeks of tolebrutinib 60 mg (initialcohort), or 48 weeks of treatment with tolebrutinib 60 mg and 96 weeks oftreatment with tolebrutinib 120 mg (Cohort A), all following anti-CD20antibody...

To assess the possible repair of chronically inflamed white matter lesions in which inflammation at the lesion edge has been modulated by tolebrutinib.