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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
Fully vaccinated against SARS-CoV-2 by Day 0
Has a prior 7-tesla MRI scan, no more than 1 year prior to enrollment, demonstrating at least one white matter lesion with a paramagnetic rim
Must not have
Is receiving potent and moderate inducers and inhibitors of cytochrome P450 3A (CYP3A) or potent inhibitors of CYP2C8 hepatic enzymes
Bleeding disorder or known platelet dysfunction at any time prior to the first screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline vs. 96 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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 fully vaccinated against COVID-19.
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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 not to receive any anti-CD20 antibody treatments during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking strong drugs that affect liver enzymes CYP3A or CYP2C8.
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I have a history of bleeding disorders or platelet problems.
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I am HIV-positive.
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I have not had a fever or needed antibiotics, antivirals, or antifungals for an infection in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 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
Disappearance of Paramagnetic Rim Lesions at 48 Weeks of 60 mg of Tolebrutinib.
Secondary study objectives
Repair of Chronically Inflamed White Matter Lesions
Safety and Tolerability of Tolebrutinib.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: tolebrutinib (initial cohort)Experimental Treatment1 Intervention
Tolebrutinib 60 mg daily
Group II: Tolebrutinib (cohort B)Experimental Treatment1 Intervention
Tolebrutinib 120 mg daily
Group III: Tolebrutinib (Cohort A)Experimental Treatment2 Interventions
Tolebrutinib 60 mg/day for 48 weeks, Tolebrutinib 120 mg/day for 96 weeks

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,381 Previous Clinical Trials
652,238 Total Patients Enrolled
37 Trials studying Multiple Sclerosis
9,748 Patients Enrolled for Multiple Sclerosis
Daniel S Reich, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
11 Previous Clinical Trials
4,422 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
4,321 Patients Enrolled for Multiple Sclerosis

Media Library

Tolebrutinib (Bruton's Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04742400 — Phase 2
Multiple Sclerosis Research Study Groups: Tolebrutinib (cohort B), Tolebrutinib (Cohort A), tolebrutinib (initial cohort)
Multiple Sclerosis Clinical Trial 2023: Tolebrutinib Highlights & Side Effects. Trial Name: NCT04742400 — Phase 2
Tolebrutinib (Bruton's Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04742400 — Phase 2
~3 spots leftby Dec 2025
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