Fenebrutinib for Multiple Sclerosis

(FENopta Trial)

Not currently recruiting at 23 trial locations

Overseen By Reference Study ID Number: GN43271 https://forpatients.roche.com/

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Must not be taking: Systemic corticosteroids, Immunosuppressants

Disqualifiers: Cancer, Neurological disorders, Cardiovascular, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called fenebrutinib for individuals with relapsing multiple sclerosis (RMS). The main goal is to assess fenebrutinib's effects on brain scans, its safety, and how the body processes it. Participants will be randomly assigned to receive either fenebrutinib or a placebo (a pill with no active drug) during the trial. Individuals diagnosed with RMS, excluding those with primary progressive or non-active secondary progressive forms, might be suitable for this study. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it mentions that any previous treatment with immunomodulatory or immunosuppressive medication requires an appropriate washout period (time without taking certain medications).

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that fenebrutinib is generally safe for people with relapsing multiple sclerosis. Studies have found that those taking fenebrutinib experienced fewer relapses and no new brain lesions after nearly two years, suggesting the treatment might be effective with minimal issues.

Another study found that fenebrutinib was safe and positively affected the brain, with most participants not experiencing serious side effects. While more research is needed, these findings suggest that fenebrutinib is safe for people with multiple sclerosis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple sclerosis?

Fenebrutinib is unique because it targets Bruton’s tyrosine kinase (BTK), a key player in the immune system involved in inflammation and nerve damage. Unlike current multiple sclerosis treatments that generally modulate the immune response, fenebrutinib precisely inhibits BTK, potentially reducing side effects and improving outcomes. Researchers are excited because this targeted approach could offer a new avenue for managing multiple sclerosis, especially for patients who don't respond well to existing therapies.

What evidence suggests that fenebrutinib might be an effective treatment for multiple sclerosis?

Research has shown that fenebrutinib, which participants in this trial may receive, may help treat relapsing multiple sclerosis (RMS). Studies found that patients taking fenebrutinib experienced fewer relapses, meaning they had fewer symptom flare-ups. The treatment also reduced new brain lesions, which are damaged areas in the brain. Over nearly two years, patients showed no new active brain lesions or worsening of their condition. This suggests that fenebrutinib effectively reduces disease activity and protects the brain in people with RMS. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for people with Relapsing Multiple Sclerosis (RMS) who meet the 2017 McDonald Criteria, have an EDSS score of 0-5.5, and agree to use birth control. It's not for those with a disease duration over 10 years and low disability, pregnant or planning pregnancy, non-active SPMS, certain infections like TB or hepatitis B/C, cancer in the last decade, recent steroid therapy or vaccines, untreated drug abuse within a year.

Inclusion Criteria

My RMS diagnosis follows the 2017 McDonald Criteria.

Female participants of childbearing potential must agree to remain abstinent or use contraceptive measures, and refrain from donating eggs

I am a man and agree to not have unprotected sex or donate sperm.

Exclusion Criteria

I haven't taken any corticosteroid medicines in the last 4 weeks.

You are not able to have an MRI scan.

I do not have any major heart, lung, kidney, liver, hormone, metabolism, or stomach conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either fenebrutinib or placebo, with MRI scans at Weeks 4, 8, and 12 to evaluate lesion rates

12 weeks

MRI scans at Weeks 4, 8, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term, with monitoring for adverse events

Up to 192 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fenebrutinib
• Placebo

Trial Overview The study tests Fenebrutinib's effects on brain MRI results in RMS patients compared to a placebo. Participants will be randomly assigned to receive either Fenebrutinib or a dummy pill without any active medication.

How Is the Trial Designed?

Group I: Fenebrutinib Experimental Treatment 1 Intervention

Participants will receive oral fenebrutinib.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive oral placebo.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Citations

1. roche.com roche.com/media/releases/med-cor-2025-05-30

Roche's fenebrutinib maintains near-complete suppression ... Patients on fenebrutinib had low relapse rates with data showing no active brain lesions or disability progression after nearly two years of ...

2. gene.com gene.com/media/press-releases/15064/2025-05-29/genentechs-fenebrutinib-maintains-near-c

Phase III studies for fenebrutinib in relapsing and primary ... Patients on fenebrutinib had low relapse rates with data showing no active brain lesions or disability progression after nearly two years of ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40683275/

Safety and efficacy of fenebrutinib in relapsing multiple ... Interpretation: Fenebrutinib was well tolerated and exerted an early, robust, and sustained effect of limiting new focal brain lesions. Further studies are ...

4. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(25)00174-7/abstract

Safety and efficacy of fenebrutinib in relapsing multiple ... Fenebrutinib was well tolerated and exerted an early, robust, and sustained effect of limiting new focal brain lesions. Further studies are needed to better ...

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000209016

Fenebrutinib Maintains Low Disease Activity in Relapsing ... Fenebrutinib reduced disease activity in relapsing multiple sclerosis (RMS) and demonstrated central nervous system penetrance.

6. neurology.org neurology.org/doi/10.1212/WNL.0000000000205291

The Safety Profile of Fenebrutinib in Patients with Multiple ... To compare the safety and tolerability of fenebrutinib in people with multiple sclerosis (MS) and those with autoimmune indications (AIs).