Fenebrutinib for Multiple Sclerosis

(FENopta Trial)

Recruiting at 19 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

109 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing fenebrutinib, a medication, to see its effects on the brain in people with relapsing multiple sclerosis (RMS). Researchers will use MRI scans to observe any changes. They will also check if the drug is safe and how it is processed by the body. Participants will either receive fenebrutinib or a non-active substance.

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).

How is the drug Fenebrutinib different from other multiple sclerosis treatments?

Fenebrutinib is unique because it is a noncovalent, oral, and highly selective inhibitor of Bruton's tyrosine kinase (BTK), which is different from other MS treatments like alemtuzumab and cladribine that are administered as short courses and work by reconstituting the immune system. ^{1 2 3 4 5}

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. England pubmed.ncbi.nlm.nih.gov

Antibody response to SARS-CoV-2 vaccines in patients with relapsing multiple sclerosis treated with evobrutinib: A Bruton's tyrosine kinase inhibitor. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Determination of a clinically effective evobrutinib dose: Exposure-response analyses of a phase II relapsing multiple sclerosis study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Double immune reconstitution therapy: Cladribine after alemtuzumab in the treatment of multiple sclerosis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy, Safety, and Pharmacodynamic Effects of the Bruton's Tyrosine Kinase Inhibitor Fenebrutinib (GDC-0853) in Systemic Lupus Erythematosus: Results of a Phase II, Randomized, Double-Blind, Placebo-Controlled Trial. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A real-world single-centre analysis of alemtuzumab and cladribine for multiple sclerosis. [2021]