Active not recruitingPHASE3INTERVENTIONAL

Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)

This research study is testing a new medication called fenebrutinib for adults who have a form of multiple sclerosis known as relapsing MS. This type of MS involves periods where symptoms get worse, followed by recovery. The study aims to find out if fenebrutinib is effective at slowing down the progression of disability and reducing the number of MS relapses, and to check if it's safe to use. Half of the participants will receive fenebrutinib, while the other half will receive teriflunomide, an approved MS treatment. After the first part of the study, there might be an option for participants to continue receiving fenebrutinib in an extended phase.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

751

Start

24 Mar 2021

Estimated completion

09 Jul 2027

Relapsing Multiple Sclerosis

What is this study about?

This study is focusing on adults who have relapsing multiple sclerosis, often shortened to RMS. RMS is a condition where the body's immune system mistakenly attacks its own brain and spinal cord, leading to a range of symptoms. These symptoms can come and go, or get better and worse over time. The main goal of this research is to see if a new medicine, fenebrutinib, can help people with RMS.

Researchers want to understand two key things. First, they want to know if fenebrutinib can help to slow down how much the MS progresses and affects a person's abilities. Second, they're looking to see if it can reduce the number of 'relapses' – periods when MS symptoms flare up or get worse. They will also be carefully checking how safe fenebrutinib is and if it causes any unwanted side effects.

To do this, the study is comparing fenebrutinib with an existing MS treatment called teriflunomide. Participants will be randomly chosen to receive one of these medications. This helps make sure the comparison is fair. After the main part of the study, if it looks like fenebrutinib is promising, there might be a chance for participants to continue taking it in an open-label extension phase, meaning everyone would know they are receiving fenebrutinib.

Key takeaways

This study is testing a new MS drug, fenebrutinib, for relapsing multiple sclerosis.
It compares fenebrutinib to an existing treatment, teriflunomide.
The main goals are to see if fenebrutinib reduces relapses and slows disability progression.
Safety and side effects of fenebrutinib will also be carefully monitored.
Participants will be randomly assigned to one of the two medicines and monitored closely.
There might be an option to continue treatment with fenebrutinib after the main study.

Who may be eligible?

To be able to join this study, you would need to be between 18 and 55 years old and have a diagnosis of relapsing multiple sclerosis (RMS). Your MS should not be too advanced, meaning your disability score (EDSS) needs to be under a certain level.

You also need to be able to complete some short physical tests, like moving pegs into holes and walking a certain distance, within a set time. If you are female and could become pregnant, you must agree to use effective birth control or avoid sex during the study. The same applies to male participants who could father a child.

You cannot join if you have very long-standing MS with a low disability score, or if you have other types of MS like primary progressive or non-active secondary progressive MS. You also can't be pregnant, breastfeeding, or planning to get pregnant or father a child during the study. If you have an active infection, including certain types of hepatitis, you also wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 55 years old?
Do you have a diagnosis of relapsing multiple sclerosis?
Are you able to do simple physical tasks like peg tests and walking a short distance?
Are you not pregnant, breastfeeding, or planning to become so during the study (or father a child)?
Do you not have other specific MS types (like primary progressive)?
Are you free from certain active infections?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to receive either the new medicine (fenebrutinib) or an existing MS medicine (teriflunomide). You won't know which one you are getting, and neither will your study doctor, for the initial part of the study. This is called a "double-blind" phase.

During this time, you will have regular visits to the clinic where the study team will carry out various assessments. These will include check-ups, questions about your health, and tests to see how your MS is developing and if the medicine is having an effect. You'll also have blood tests and other examinations to monitor your health and safety. You'll take your assigned study medication as directed.

After this main part of the study, if the results are good, there might be an option to continue into an "open-label extension" phase. In this phase, everyone would know they are receiving fenebrutinib. If you were on teriflunomide in the first phase, you might need a special procedure to clear that medicine from your system before starting fenebrutinib. The total duration of your involvement in the study will depend on how long these phases last.

Potential risks and benefits

Participating in a clinical trial like this could offer potential benefits, such as gaining access to a new treatment before it's widely available, and receiving close medical monitoring throughout the study. However, there are also potential risks. The new medicine might not work for you, or you could experience side effects that range from mild to serious. The existing medication (teriflunomide) also has known side effects, and some procedures like blood tests carry small risks. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (108)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

North Central Neurology Associates
Verified postcode
Cullman, United States
Xenoscience
Verified postcode
Phoenix, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA
Verified postcode
Torrance, United States
KI Health Partners, LLC
Verified postcode
Stamford, United States
Georgetown University Medical Center
Verified postcode
Washington D.C., United States
University of South Florida
Verified postcode
Tampa, United States
American Health Network Institute, LLC
Verified postcode
Avon, United States
University of Kansas Medical Center
Verified postcode
Kansas City, United States
Neuro Institute of New England P.C.
Verified postcode
Foxborough, United States
University of Cincinnati
Verified postcode
Cincinnati, United States
Hope Neurology
Verified postcode
Knoxville, United States
Integrated Neurology Services PLLC
Verified postcode
Falls Church, United States

Common questions

What is Relapsing Multiple Sclerosis (RMS)?

RMS is a type of MS where you have clear attacks or 'relapses' of symptoms, followed by periods of recovery. Symptoms can include problems with vision, balance, or numbness.

What is fenebrutinib?

Fenebrutinib is a new medicine being tested to see if it can help control RMS by reducing relapses and slowing down MS progression.

What does 'randomized' mean in a study?

It means you're put into a treatment group (either fenebrutinib or teriflunomide) by chance, like flipping a coin. This ensures the study is fair.

Can I stop participating in the study if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, and it won't affect your future medical care.

Why do they compare fenebrutinib to teriflunomide?

Teriflunomide is an approved treatment for MS. Comparing the new medicine to an existing one helps researchers understand if the new one is better or safer.