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Tolebrutinib, a Brain-penetrant Bruton's Tyrosine Kinase Inhibitor, for the Modulation of Chronically Inflamed White Matter Lesions in Multiple Sclerosis

NCT04742400 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-08-13

Study results available
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Summary

Background:

Some multiple sclerosis (MS) lesions stay inflamed for very long periods of time. This type of inflammation is not affected by any MS medications. These lesions can lead to slow worsening of MS symptoms. Researchers want to see if a new drug can help.

Objective:

To see if tolebrutinib can help clear inflammation in MS brain lesions.

Eligibility:

Adults ages 18 and older with MS who are on an anti-CD20 therapy.

Design:

Participants will be screened under protocol #89-N-0045.

Participants will have a medical history. They will have physical and neurological exams. They will have blood and urine tests. The progression of their MS will be assessed.

Participants will have MRIs of the brain. The MRI scanner is shaped like a cylinder. It uses a magnetic field and radio waves to take pictures of the body. During the MRIs, participants will lie on a table that slides in and out of the scanner. Soft padding or a coil will be placed around their head.

Participants may have electrocardiograms to measure the heart s electrical activity.

Participants may have lumbar punctures ( spinal taps ). A small needle will be inserted into the spinal canal in the lower back. Fluid will be collected.

Some participants will take tolebrutinib pills by mouth once a day for at least 96 weeks. They will stop their anti-CD20 therapy. They will have at least 10 study visits.

Some participants will not take tolebrutinib. They will stay on their anti-CD20 therapy. They will have 5 study visits.

Participation will last at least 96 weeks.

Conditions

Interventions

DRUG

tolebrutinib 60mg

60 mg orally

DRUG

tolebrutinib 120mg

120 mg orally

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    lead NIH

Principal Investigators

  • Daniel S Reich, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2023-06-15
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04742400 on ClinicalTrials.gov