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Study on Fenebrutinib for Patients with Relapsing Multiple Sclerosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Relapsing Multiple Sclerosis, a condition where the immune system mistakenly attacks the protective covering of nerves, causing communication problems between the brain and the rest of the body. The study will evaluate the effectiveness of a medication called Fenebrutinib, which is taken as a film-coated tablet. Participants in the study will either receive Fenebrutinib or a placebo, which looks like the medication but does not contain the active substance.

The purpose of the study is to assess how well Fenebrutinib works in reducing the number of new lesions in the brain, which are areas of damage that can be seen on an MRI scan. These lesions are a sign of disease activity in multiple sclerosis. The study will involve regular MRI scans at specific intervals to monitor the development of these lesions over time.

Participants will be monitored for any side effects and changes in their health throughout the study. The trial will also measure the concentration of Fenebrutinib in the blood at certain times to understand how the body processes the medication. The study aims to provide valuable information on the potential benefits of Fenebrutinib for people with relapsing multiple sclerosis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of relapsing multiple sclerosis, and other health conditions.
Participants must agree to certain conditions regarding contraception and donation of reproductive cells during the study period.
Step 2
Randomization and initial assessment
Participants are randomly assigned to receive either fenebrutinib or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.
Initial assessments include a magnetic resonance imaging (MRI) scan to establish a baseline for comparison throughout the study.
Step 3
Medication administration
Participants take the assigned medication orally in the form of a film-coated tablet. The dosage and frequency are determined by the study protocol.
The treatment period continues until the study's estimated end date in December 2026.
Step 4
Regular monitoring and assessments
MRI scans are conducted at weeks 4, 8, and 12 to monitor the number of new gadolinium-enhancing T1 lesions and T2-weighted lesions.
Participants' health is monitored through regular assessments of vital signs, laboratory tests, and evaluation of any adverse events.
Step 5
Evaluation of outcomes
The primary outcome is the total number of new gadolinium-enhancing T1 lesions observed on MRI scans.
Secondary outcomes include the number of new or enlarging T2-weighted lesions, the incidence of adverse events, and changes in vital signs and laboratory test results.
Step 6
Completion of the study
Upon completion of the study, participants undergo a final assessment to evaluate the overall effects of the treatment.
Participants are informed of the study results and their individual treatment allocation after the study concludes.

Who can join the trial?

7 criteria

Participants must be between 18 and 55 years old when they sign the consent form.
Participants must have a diagnosis of relapsing multiple sclerosis (RMS), which is a type of multiple sclerosis where symptoms come and go. This diagnosis should follow specific guidelines known as the 2017 McDonald Criteria.
Participants should have experienced at least two flare-ups of their condition in the last two years, or one flare-up in the last year, but not within 30 days before the study starts.
Participants should have evidence of at least one new lesion, which is a damaged area, on an MRI scan in the six months before joining the study. An MRI is a type of scan that uses magnets and radio waves to create pictures of the inside of the body.
Participants should have a score between 0 and 5.5 on the Expanded Disability Status Scale (EDSS), which is a method used to measure the level of disability in people with multiple sclerosis.
Women who can have children must agree to either not have sexual intercourse or use birth control during the study and for 28 days after the last dose of the study medication. They must also agree not to donate eggs during this time.
Men must agree to either not have sexual intercourse or use a condom during the study and for 28 days after the last dose of the study medication. They must also agree not to donate sperm during this time to prevent any risk to an embryo.

Who cannot join the trial?

8 criteria

Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to the study medication or similar drugs are excluded.
Patients with other serious health conditions that could interfere with the study are not eligible.
Patients who have participated in another clinical trial within the last 30 days are not allowed.
Patients with a history of drug or alcohol abuse in the past year are excluded.
Patients who are unable to comply with the study procedures or follow-up visits cannot participate.
Patients with certain types of infections, such as active tuberculosis, are not eligible.
Patients who have received certain treatments for multiple sclerosis within a specific time frame before the study are excluded.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Fakultni Nemocnice Hradec Kralove
Verified
Novy Hradec Kralove, Czechia
Fakultni Nemocnice U Sv Anny V Brne
Verified
Brno-Stred, Czechia
KBC Zagreb
Responsive
Zagreb, Croatia

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Investigated drugs

Fenebrutinib is a medication being studied for its potential to help people with relapsing multiple sclerosis. It is being tested to see if it can reduce the number of new lesions in the brain, which are detected using MRI scans. These lesions are a sign of disease activity in multiple sclerosis, and reducing them could mean the medication is effective in managing the condition.

What is already known about the treatment

Fenebrutinib – Fenebrutinib is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating relapsing multiple sclerosis. The main therapeutic indication for fenebrutinib is to reduce the number of new lesions in the brain, as seen on MRI scans, in patients with this condition. At the molecular level, fenebrutinib works by inhibiting a specific enzyme called Bruton's tyrosine kinase, which plays a role in the immune system's activity. It is classified as a kinase inhibitor in pharmacology.

Investigated diseases

Relapsing Multiple Sclerosis – This is a chronic disease affecting the central nervous system, characterized by episodes of new or increasing neurological symptoms. These episodes, known as relapses, are followed by periods of partial or complete recovery. The disease involves an immune-mediated process where the body's immune system attacks the protective covering of nerve fibers, causing inflammation and damage. Over time, this can lead to the formation of scar tissue and permanent damage to the nerves. The progression of the disease can vary greatly among individuals, with some experiencing frequent relapses and others having long periods of stability. Symptoms can include fatigue, difficulty walking, numbness, and problems with coordination and balance.