Active not recruitingPHASE3INTERVENTIONAL

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

This research study is investigating a new medication, fenebrutinib, for adults living with relapsing multiple sclerosis (RMS). The main goal is to find out if fenebrutinib is both safe and effective. Researchers will compare it to an already approved medicine called teriflunomide. We want to see if fenebrutinib can help reduce disability worsening and the number of MS relapses or flare-ups. Participants will be randomly assigned to receive either fenebrutinib or teriflunomide. After the initial treatment period, there might be an option to continue receiving fenebrutinib in a longer-term part of the study. This trial helps doctors understand if fenebrutinib could be a good new treatment option for RMS.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

746

Start

17 Mar 2021

Estimated completion

30 Nov 2027

Relapsing Multiple Sclerosis

What is this study about?

This study is a clinical trial looking at a new medication called fenebrutinib. It's for adults who have a type of multiple sclerosis (MS) called relapsing multiple sclerosis, often shortened to RMS. RMS is a condition where symptoms can come and go, with periods of new or worsening symptoms called relapses.

The main aim of this study is to see how well fenebrutinib works compared to another medicine, teriflunomide, which is already used to treat RMS. We want to find out if fenebrutinib can help slow down the progression of MS and reduce the number of relapses people experience. The study also carefully checks for any side effects of fenebrutinib, making sure it’s safe for people to use.

Taking part in studies like this is really important. It helps doctors and researchers learn more about MS and find new and better ways to treat it, ultimately improving the lives of people living with the condition.

Key takeaways

This study is testing a new MS medicine called fenebrutinib.
It aims to see if fenebrutinib can reduce MS relapses and disability.
You'll be compared to another MS medicine, teriflunomide.
Participation involves regular clinic visits and health checks.
Strict rules apply regarding pregnancy and family planning.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, participants need to be between 18 and 55 years old and have a diagnosis of relapsing multiple sclerosis (RMS). Your MS should cause some disability, but not be too severe, meaning you can still perform certain physical tasks fairly well, like walking a set distance or using your hands for a peg test.

There are also some important criteria about family planning. Women who could become pregnant and men who could father a child must agree to use effective contraception throughout the study. This is to protect any potential pregnancies from the study medicines.

You wouldn't be able to join if you have a different type of MS, such as primary progressive MS, or if you have certain other serious health issues, like an active infection. Women who are pregnant or breastfeeding, or planning to become pregnant soon, cannot participate, and the same applies to men planning to father a child during the study.

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?
Have you been diagnosed with relapsing multiple sclerosis (RMS)?
Are you able to walk a short distance and use your hands for small tasks?
Are you able to use reliable contraception throughout the study if you could become pregnant or father a child?
Do you not have active infections or other complicating health conditions?
Are you not pregnant, breastfeeding, or planning to conceive soon?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance to receive either fenebrutinib or teriflunomide. You won't know which one you're getting, and neither will your study doctor, for the initial part of the study. You'll have regular visits to the clinic where you'll have check-ups, answer questions about how you're feeling, and have tests like blood samples or neurological exams to see how your MS is progressing. You'll also complete some physical tests, like walking and hand coordination tasks.

After a certain period, once the initial results are reviewed, there might be an option to continue taking fenebrutinib in a longer-term part of the study, if the researchers decide to open it. If you were on teriflunomide during the first part and wish to join the longer-term part, you might need a special procedure to help remove teriflunomide from your system first. The total duration of your participation will depend on the study design and whether you continue into the longer-term phase.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is receiving treatment for your MS and being closely monitored by medical professionals. If fenebrutinib proves effective, you could be among the first to benefit from a new treatment option. However, as with any medication, fenebrutinib or teriflunomide could cause side effects, some of which might be severe or unexpected. Your study team will explain all known risks. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (160)

University of Alabama Birmingham
Verified postcode
Birmingham, United States
Alabama Neurology Associates
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Homewood, United States
Center for Neurology and Spine - Phoenix - Hunt - PPDS
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Phoenix, United States
Profound Research, LLC
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Carlsbad, United States
University of California Irvine
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Irvine, United States
Quantum Clinical Research, Inc
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Pasadena, United States
University of Colorado Denver
Verified postcode
Aurora, United States
Mountain View Clinical Research
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Denver, United States
Advanced Neurology of Colorado, LLC
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Fort Collins, United States
Neurology Associates, PA; Research Department
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Maitland, United States
NorthShore University HealthSystem
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Highland Park, United States
Fort Wayne Neurological Center
Verified postcode
Fort Wayne, United States

Common questions

What is relapsing multiple sclerosis (RMS)?

RMS is a type of MS where symptoms come and go. You might have periods of new or worsening symptoms (relapses) followed by times when symptoms improve or disappear (remission).

What are fenebrutinib and teriflunomide?

Fenebrutinib is an experimental medicine being tested in this study. Teriflunomide is a medicine already approved and used to treat RMS.

Will I know which medicine I'm getting?

For the first part of the study, neither you nor your study doctor will know if you're taking fenebrutinib or teriflunomide. This is common in studies to ensure fair results.

What if I get pregnant or want to have children during the study?

Women who could become pregnant and men who could father a child must use contraception and cannot try for a baby during the study. This is to protect any potential pregnancies from the study medications.

Can I stop participating if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your standard medical care.