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Study on Fenebrutinib and Teriflunomide for Adults with Relapsing Multiple Sclerosis

Fast replyRegistered drugNo placebo

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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 a condition known as Relapsing Multiple Sclerosis (RMS). RMS is a type of multiple sclerosis where patients experience episodes of new or worsening symptoms, known as relapses, followed by periods of recovery. The study aims to evaluate the effectiveness and safety of a medication called Fenebrutinib compared to another medication called Teriflunomide. Fenebrutinib is taken in the form of film-coated tablets and is being tested to see how well it works in reducing the frequency of relapses in patients with RMS.

Participants in the study will be randomly assigned to receive either Fenebrutinib, Teriflunomide, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drugs being tested. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving which treatment, to ensure unbiased results. The trial will last for a period of time during which participants will take the medication orally, and their health will be monitored regularly to assess the impact of the treatment on their condition.

The main goal of the study is to determine how well Fenebrutinib works in reducing the annualized relapse rate, which is the average number of relapses a patient experiences in a year. Additionally, the study will look at other factors such as changes in brain volume, the number of new or enlarging lesions detected by MRI scans, and any side effects experienced by participants. This research is important for understanding the potential benefits and risks of Fenebrutinib as a treatment option for people living with RMS.

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
Randomization
Upon joining the study, you will be randomly assigned to one of two groups. One group will receive fenebrutinib, and the other will receive teriflunomide. This process is called randomization and ensures that the study results are unbiased.
Step 2
Medication administration
If assigned to the fenebrutinib group, you will take fenebrutinib in the form of a film-coated tablet orally. The dosage and frequency will be determined by the study protocol.
If assigned to the teriflunomide group, you will take AUBAGIO 14 mg film-coated tablets orally. The dosage and frequency will be determined by the study protocol.
Step 3
Double-blind treatment phase
During this phase, neither you nor the study team will know which medication you are receiving. This is to ensure that the results are not influenced by expectations or bias.
Step 4
Monitoring and assessments
Throughout the study, regular assessments will be conducted to monitor your health and the effects of the medication. These assessments may include physical exams, blood tests, and imaging studies such as MRI scans.
You will also be asked to complete questionnaires about your symptoms and quality of life.
Step 5
End of treatment phase
At the end of the treatment phase, you will undergo final assessments to evaluate the effects of the medication on your condition.
The study team will review all collected data to determine the efficacy and safety of the medications.
Step 6
Follow-up
After completing the treatment phase, you may be asked to participate in follow-up visits to monitor your health and any long-term effects of the medication.

Who can join the trial?

7 criteria

The patient must have a score between 0.0 and 5.5 on the Expanded Disability Status Scale (EDSS), which is a way to measure how much multiple sclerosis affects a person's ability to move and function.
The patient must have a diagnosis of Relapsing Multiple Sclerosis (RMS) according to the 2017 McDonald Criteria, which are guidelines used by doctors to diagnose this type of multiple sclerosis.
The patient must be neurologically stable, meaning their condition should not have changed, for at least 30 days before starting the study and before any initial tests.
The patient must be able to complete the 9-Hole Peg Test (9-HPT) for each hand in less than 240 seconds. This test checks how well a person can use their hands and fingers.
The patient must be able to perform the Timed 25-Foot Walk Test in less than 150 seconds. This test measures how quickly a person can walk a short distance.
If the patient has completed the Double-Blind Treatment phase of the study and has not received any other Disease-Modifying Therapy (DMT), they may be included if the study doctor believes they could benefit from the treatment being tested.
Both male and female patients are eligible to participate in the study.

Who cannot join the trial?

4 criteria

Patients who do not have a diagnosis of relapsing multiple sclerosis (RMS) cannot participate. RMS is a type of multiple sclerosis where symptoms come and go.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population may not be eligible. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.
Patients who do not meet other specific health criteria set by the study may be excluded. These criteria are not detailed here but are important for safety and accuracy.

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Verified sites

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

Responsive
Azienda Ospedaliero Universitaria Parma
Parma, Italy
Responsive
Azienda Ospedaliero-Universitaria Sant Andre
Rome, Italy
Responsive
Centrum Neurologii Krzysztof Selmaj
Lodz, Poland

Trial locations

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Investigated drugs

Fenebrutinib
is a medication being studied for its potential to help people with relapsing multiple sclerosis. It works by targeting specific proteins in the body that are involved in the immune response, which may help reduce the frequency of relapses in patients.
Teriflunomide
is a medication already used to treat relapsing multiple sclerosis. It helps to reduce the number of relapses by modulating the immune system, which can help slow down the progression of the disease.

What is already known about the treatment

Fenebrutinib
Fenebrutinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating relapsing multiple sclerosis (RMS). It is not yet widely available in medical practice as it is still under investigation. The main therapeutic indication for fenebrutinib is to reduce the frequency of relapses in patients with RMS. At the molecular level, fenebrutinib works by inhibiting Bruton's tyrosine kinase (BTK), which plays a role in the immune response that contributes to the progression of multiple sclerosis. It is classified pharmacologically as a BTK inhibitor.
Teriflunomide
Teriflunomide is an oral medication that is already approved and used in the treatment of relapsing multiple sclerosis (RMS). It is well-documented in medical literature and is commonly prescribed to help reduce the frequency of relapses in RMS patients. Teriflunomide works by inhibiting the enzyme dihydroorotate dehydrogenase, which is involved in the synthesis of pyrimidine, thereby reducing the proliferation of activated T and B lymphocytes. It is classified as an immunomodulatory agent.

Investigated diseases

Relapsing Multiple Sclerosis – Relapsing multiple sclerosis (RMS) is a chronic disease affecting the central nervous system, characterized by episodes of new or worsening neurological symptoms, known as relapses. These relapses are followed by periods of partial or complete recovery, called remissions. The disease involves an immune-mediated process where the body's immune system mistakenly attacks the protective covering of nerve fibers, leading to communication problems between the brain and the rest of the body. Over time, RMS can lead to physical and cognitive disabilities. The progression of the disease varies among individuals, with some experiencing frequent relapses and others having long periods of remission. RMS is one of the most common forms of multiple sclerosis, primarily affecting young adults.