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Phase III Study of the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult 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

relapsing multiple sclerosis is a condition in which the immune system mistakenly attacks the protective covering of nerve fibers in the brain and spinal cord, causing episodes of new symptoms or worsening of old ones. This study compares two oral medicines: the experimental drug fenebrutinib and the approved therapy teriflunomide. Participants will receive either the active medication or a matching placebo so that the pills look the same, and they will not know which one they are taking.

The purpose of the study is to see whether fenebrutinib can reduce the number of relapses more effectively than teriflunomide. It is a large, randomized trial where participants are assigned by chance to one of the treatment groups, and both the participants and the study staff are unaware of the assignments (double‑blind). The trial lasts about a year, during which safety and overall health are monitored.

During the study, participants will take a daily film‑coated tablet and attend regular visits that include a simple blood draw, a quick heart test called an ECG, and a brain scan using MRI. The MRI uses a special dye called gadolinium to highlight areas of activity and looks at both T1-weighted and T2-weighted images, which are just different ways the scanner shows the brain. The scan also measures changes in brain volume. In addition, participants will fill out a questionnaire called MSIS-29 about how the disease affects daily life, take a short mental speed test known as the SDMT, and have a blood test for a protein called neurofilament light chain that can signal nerve damage. All of these steps are designed to track how well the medicines work and whether they are safe.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and start of medication

    After joining the study you are assigned to receive either fenebrutinib 400 mg or teriflunomide 14 mg. because the study uses a double‑dummy design, you will also receive matching placebo tablets so that the number of pills taken each day is the same for all participants.

    Both the active drug and the matching placebo are taken by mouth as a single film‑coated tablet each day.

  2. Step 2

    Baseline assessments

    On the first study day a series of assessments are performed before the first dose is taken. these include a physical examination, collection of blood samples, and magnetic resonance imaging (mri) of the brain to record the initial number of lesions.

    Questionnaires about the impact of multiple sclerosis on daily life are completed.

  3. Step 3

    Daily dosing period

    You take the assigned study medication and the matching placebo tablet every day, at the same time each day, for the duration of the trial. the treatment period lasts at least 48 weeks.

  4. Step 4

    Regular clinic visits

    Scheduled visits occur approximately every 4 to 12 weeks (for example at weeks 4, 12, 24, 36, and 48). during each visit a clinician checks for any side effects, measures vital signs, and records any relapses of multiple sclerosis.

    Blood is drawn at each visit to monitor safety and to measure the level of fenebrutinib in the blood for participants who receive it.

  5. Step 5

    Mid‑study magnetic resonance imaging

    At week 24 a second brain mri scan is performed to evaluate changes in the number of lesions and overall brain volume.

  6. Step 6

    Patient‑reported outcome questionnaires

    At designated visits (for example weeks 12, 24, 36, and 48) you complete the Multiple Sclerosis Impact Scale (MSIS‑29) to report physical effects of the disease.

  7. Step 7

    Final assessments

    At week 48 a final set of evaluations is performed. this includes a physical exam, blood tests, a third brain mri scan, and completion of the MSIS‑29 questionnaire.

    The occurrence of any relapses, side effects, or serious adverse events is recorded, and the study medication is stopped.

  8. Step 8

    Study completion

    After the final visit you are no longer required to take the study medication. study staff may provide information about post‑study follow‑up, but no further study procedures are required.

Who can join the trial?

6 criteria

  • Have an Expanded Disability Status Scale (EDSS) score between 0.0 and 5.5 at the screening visit. The EDSS is a simple scale that measures how much disability a person with MS has.
  • Have a diagnosis of relapsing multiple sclerosis (RMS) that meets the revised 2017 McDonald Criteria, which are the standard guidelines doctors use to confirm MS.
  • Be neurologically stable—meaning no new symptoms or worsening—for at least 30 days before being randomly assigned to a treatment and before baseline tests are done.
  • Be able to complete the 9‑Hole Peg Test (9‑HPT) for each hand in less than 240 seconds. This test checks how quickly you can place and remove small pegs, measuring hand dexterity.
  • Be able to finish the timed 25‑Foot Walk Test in under 150 seconds. This test measures how fast you can walk a short distance.
  • Have finished the study’s Double‑Blind Treatment (DBT) phase, remain on the study medication without taking any other Disease‑Modifying Therapy (DMT), and have a doctor who believes you may benefit from the study drug fenebrutinib.

Who cannot join the trial?

6 criteria

  • A diagnosis of primary progressive multiple sclerosis (PPMS) or non‑active secondary progressive multiple sclerosis (SPMS) means you cannot join the study.
  • If you have had multiple sclerosis for more than 10 years and your disability rating on the EDSS (Expanded Disability Status Scale) is less than 2.0 (very mild disability), you are excluded.
  • Any known or suspected active infection at the start of the study, or a serious infection that required a hospital stay or treatment with IV (intravenous) antibiotics within the past 8 weeks, or treatment with oral antibiotics within the past 2 weeks, will exclude you. A fungal nail infection (onychomycosis) is allowed only if you are not taking medicine that works throughout the whole body.
  • A history of cancer, including blood cancers (hematologic malignancies) or solid tumors, within the last 10 years prevents participation.
  • Having other brain or nerve disorders that could confuse the diagnosis of multiple sclerosis, or having serious heart, mental health, lung, kidney, liver, hormone, metabolism, or digestive system diseases, makes you ineligible.
  • If you have a condition that would likely require long‑term treatment with systemic corticosteroids (steroids taken by mouth or injection) or other immunosuppressant drugs during the study period, you cannot take part.
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Investigated drugs

  • Fenebrutinib

    is an oral medication taken as a film‑coated tablet. In this study it is being tested as a possible treatment for adults with relapsing multiple sclerosis. Participants receive Fenebrutinib to see if it can reduce the number of disease relapses compared with the standard therapy. The drug works by targeting specific pathways in the immune system that are thought to be involved in the inflammation and damage caused by multiple sclerosis.

  • Teriflunomide

    (commercially known as Aubagio) is also an oral, film‑coated tablet used to treat relapsing multiple sclerosis. In the trial it serves as the active comparator, meaning it is the standard medication against which Fenebrutinib’s effectiveness is measured. Patients taking Teriflunomide are monitored to determine how well it prevents relapses, providing a reference point for evaluating the new drug’s performance.

What is already known about the treatment

  • Fenebrutinib

    This drug is taken as a 400 mg film‑coated tablet taken by mouth once daily. It is an investigational Bruton’s tyrosine kinase (BTK) inhibitor currently in Phase III trials for relapsing multiple sclerosis and has not yet received market approval. Fenebrutinib is being studied to treat relapsing multiple sclerosis by blocking BTK, which reduces the activity of B‑cells and other immune cells that drive inflammation in the brain. It belongs to the pharmacological class of BTK inhibitors, a type of small‑molecule targeted therapy.

  • Teriflunomide

    This medication is provided as a 14 mg film‑coated tablet taken orally, usually once daily. It is an approved disease‑modifying drug for relapsing forms of multiple sclerosis and is widely used in clinical practice. Teriflunomide works by inhibiting the enzyme dihydroorotate dehydrogenase, which lowers the production of building blocks needed for rapidly dividing immune cells, thereby reducing inflammation. It is classified as an immunomodulator and a pyrimidine synthesis inhibitor.

Investigated diseases

Relapsing multiple sclerosis - Relapsing multiple sclerosis is a disease of the central nervous system where the immune system attacks the protective covering of nerve fibers. It causes episodes of new or worsening neurological symptoms that are followed by periods of partial or complete recovery. Over time, repeated attacks can lead to a gradual build‑up of damage in the brain and spinal cord. The condition often shows new lesions on MRI that appear during relapses and may increase even when symptoms are stable. This pattern of relapses and remissions distinguishes it from other forms of multiple sclerosis.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502618-95-00Protocol codeGN42272Estimated enrolment751 patientsSponsorF. Hoffmann-La Roche AG

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