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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
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 belowSelect...
I am fully vaccinated against COVID-19.
Select...
I had a 7-tesla MRI scan within the last year showing at least one specific type of brain lesion.
Select...
I agree not to receive any anti-CD20 antibody treatments during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline vs. 96 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline vs. 96 weeks
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.
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
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Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,342 Previous Clinical Trials
650,341 Total Patients Enrolled
36 Trials studying Multiple Sclerosis
9,298 Patients Enrolled for Multiple Sclerosis
Daniel S Reich, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
10 Previous Clinical Trials
4,321 Total Patients Enrolled
10 Trials studying Multiple Sclerosis
4,321 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking strong drugs that affect liver enzymes CYP3A or CYP2C8.I am willing and able to follow all study requirements.Your lymphocyte count is less than 1000 cells per microliter at the screening visit.I have not had a live vaccine in the last 2 months.I have been diagnosed with multiple sclerosis and my MRI scans show no new lesions in the last 6 months.I have a history of bleeding disorders or platelet problems.I tested negative for tuberculosis.I have taken certain medications within the required time before my initial evaluation.Your blood platelet count is lower than 150,000 per microliter at the screening visit.I am HIV-positive.I am fully vaccinated against COVID-19.I have been on anti-CD20 antibody treatment for at least 6 months, with my last dose within the past 6 months.I had a 7-tesla MRI scan within the last year showing at least one specific type of brain lesion.I agree to use effective birth control and not donate sperm until 12 weeks after my last dose.I agree not to receive any anti-CD20 antibody treatments during the study.I have not had a fever or needed antibiotics, antivirals, or antifungals for an infection in the last 4 weeks.I am 18 years old or older.I have had an MS flare-up within the last 6 months.Your screening tests or ECG results show values that are not normal and are considered important by the study doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Tolebrutinib (cohort B)
- Group 2: Tolebrutinib (Cohort A)
- Group 3: tolebrutinib (initial cohort)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
When will tolebrutinib likely receive FDA approval?
"While tolebrutinib has shown some efficacy in Phase 2 trials, there is currently no data supporting its use, so it received a score of 2."
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