746 Participants Needed

Fenebrutinib for Relapsing Multiple Sclerosis

(FENhance Trial)

Recruiting at 261 trial locations
RS
RS
Overseen ByReference Study ID Number: GN41851 https://forpatients.roche.com/
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. At the end of the DBT phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension phase of the study.

Will I have to stop taking my current medications?

The trial protocol 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). It's best to discuss your current medications with the study team.

Is Fenebrutinib safe for humans?

The research articles focus on the safety of Teriflunomide (Aubagio) for treating multiple sclerosis, showing it is generally well tolerated with no new safety concerns over long-term use. However, they do not provide specific safety data for Fenebrutinib.12345

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

Fenebrutinib is unique because it is being studied as a potential treatment for relapsing multiple sclerosis, whereas Teriflunomide is already an established oral drug for this condition, known for its anti-inflammatory properties and ability to reduce relapses and disease activity.23456

Research Team

CT

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

Adults with Relapsing Multiple Sclerosis (RMS) who meet specific criteria like an EDSS score of 0-5.5, can complete certain physical tests within set times, and agree to use contraception or abstain from sex. Excluded are those with disease duration over 10 years and low disability, pregnant or breastfeeding women, individuals with recent cancer history, active infections including hepatitis B/C and TB, significant blood disorders or immunodeficiency.

Inclusion Criteria

My condition meets the 2017 McDonald Criteria for RMS.
I can complete a manual dexterity test in less than 4 minutes with each hand.
I can walk 25 feet in less than 150 seconds.
See 7 more

Exclusion Criteria

I have a rare genetic issue with digesting certain sugars.
Hypoproteinemia.
I have kidney, liver problems, or Gilbert's Syndrome.
See 15 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-Blind Treatment

Participants are randomized to receive either fenebrutinib or teriflunomide in a double-blind fashion

96 weeks
Visits at Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, and 96

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Open-label Extension (optional)

Participants may opt into continuation of treatment long-term after the double-blind phase

Treatment Details

Interventions

  • Fenebrutinib
  • Placebo
  • Teriflunomide
Trial OverviewThe trial is testing the effectiveness of Fenebrutinib compared to Teriflunomide in managing RMS by looking at disability progression and relapse rate. Participants will be randomly assigned to either drug in a direct comparison study design.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: FenebrutinibExperimental Treatment2 Interventions
Participants will receive oral fenebrutinib with teriflunomide-matching placebo.
Group II: TeriflunomideActive Control2 Interventions
Participants will receive oral teriflunomide with fenebrutinib-matching placebo in a blinded fashion.

Find a Clinic Near You

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 profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Findings from Research

Teriflunomide (Aubagio®) is an effective once-daily oral treatment for relapsing forms of multiple sclerosis (RMS), approved in multiple regions including Europe and North America.
The review discusses teriflunomide's safety and efficacy based on extensive clinical trials, while also exploring its therapeutic mechanism of action, which is still being researched through various studies.
Teriflunomide (Aubagio®) for the treatment of multiple sclerosis.Bar-Or, A.[2021]
In a study of 1128 patients with relapsing-remitting multiple sclerosis, teriflunomide significantly reduced the annualized relapse rate from 0.87 to 0.35 over 24 months, indicating its effectiveness in managing the disease.
Patient satisfaction with teriflunomide was high, with significant improvements in effectiveness, convenience, and overall satisfaction reported after 24 months, while the safety profile was consistent with previous clinical trials, with 35.8% experiencing adverse events.
Real-life outcomes of teriflunomide treatment in patients with relapsing multiple sclerosis: TAURUS-MS observational study.Kallmann, BA., Tiel-Wilck, K., Kullmann, JS., et al.[2022]
Teriflunomide (Aubagio®) is an effective oral treatment for relapsing multiple sclerosis (MS), showing significant improvements in clinical outcomes and MRI measures compared to placebo and similar efficacy to interferon β-1a, based on extensive randomized controlled trials and real-world evidence.
The drug is generally well tolerated, with long-term treatment (≥ 10 years) showing sustained benefits and no new safety concerns, making it a convenient option for managing relapsing-remitting MS.
Teriflunomide: A Review in Relapsing-Remitting Multiple Sclerosis.Scott, LJ.[2021]

References

Teriflunomide (Aubagio®) for the treatment of multiple sclerosis. [2021]
Real-life outcomes of teriflunomide treatment in patients with relapsing multiple sclerosis: TAURUS-MS observational study. [2022]
Teriflunomide: A Review in Relapsing-Remitting Multiple Sclerosis. [2021]
Teriflunomide: Pediatric First Approval. [2021]
Real-world study of relapsing-remitting multiple sclerosis patients treated with Teriflunomide in Nordic countries: Quality-Of-Life, efficacy, safety and adherence outcomes. [2022]
A randomized trial of teriflunomide added to glatiramer acetate in relapsing multiple sclerosis. [2020]