A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS

A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS - Fenhance - GN41851

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54410

Enrollment

Registered

2020-11-16

Start date

2022-10-31

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Multiple Sclerosis RMS

Interventions

This study will consist of the following phases: * Screening phase * Double-blind treatment (DBT) phase * Post-DBT*safety follow-up (post-DBT*SFU) phase * Optional open-label extension (OLE) phase *

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • Age 18-55 years • Expanded Disability Status Scale score (EDSS) of 0.0-5.5 at screening • A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria • Neurologically stable for at least 30 days prior to randomization and baseline assessments • Ability to complete the 9-HPT for each hand in

Exclusion criteria

Exclusion criteria: • A diagnosis of PPMS or non-active SPMS • Disease duration of > 10 years from the onset of symptoms and an EDSS score at screening

Design outcomes

Primary

Measure	Time frame
The primary efficacy objective for this study is to evaluate the efficacy of fenebrutinib compared with teriflunomide on the basis of the primary endpoint of Annualized Relapse Rate (see Section 4.5.11 for protocol-defined relapse). A detailed description of the primary estimands is provided in Sections 2.1.1 and 6.4.1.	—

Secondary

Measure	Time frame
The secondary efficacy objective for this study is to evaluate the efficacy of fenebrutinib treatment compared with teriflunomide on the basis of the following endpoints: * Time to onset of composite 12-week confirmed disability progression (cCDP12), defined as the time from baseline to the first occurrence of a progression event according to at least one of the following three criteria; must be confirmed at a regularly scheduled visit that is at least 12 weeks after the initial disability progression: - An increase from baseline in EDSS score of >=1.0 point in patients with a baseline EDSS score of = 0.5 points in patients with a baseline EDSS score of > 5.5 (confirmed disability progression [CDP]) - >= 20% increase from baseline in the T25FWT - >= 20% increase from baseline in time to complete the 9-HPT * Time to onset of 24-week CDP (CDP24) * Total number of T1Gd+ lesions as detected by MRI * Total number of new and/or enlarging T2-weighted lesions as detected by MRI * Rate of percent change in total brain volume from Week 24 as assessed by MRI * Change in patient-reported physical impacts of MS, as measured by the Multiple Sclerosis Impact Scale (29-Item), Version 2 (MSIS-29 v2) physical scale) * Time to onset of 12-week confirmed 4-point worsening in Symbol Digit Modalities Test (SDMT) score * Change from baseline to Week 48 in the concentration of serum neurofilament light chain (NfL) The secondary endpoints above do not reflect order of statistical hierarchy.	—

Measure

Time frame

The secondary efficacy objective for this study is to evaluate the efficacy of fenebrutinib treatment compared with teriflunomide on the basis of the following endpoints: * Time to onset of composite 12-week confirmed disability progression (cCDP12), defined as the time from baseline to the first occurrence of a progression event according to at least one of the following three criteria; must be confirmed at a regularly scheduled visit that is at least 12 weeks after the initial disability progression: - An increase from baseline in EDSS score of >=1.0 point in patients with a baseline EDSS score of = 0.5 points in patients with a baseline EDSS score of > 5.5 (confirmed disability progression [CDP]) - >= 20% increase from baseline in the T25FWT - >= 20% increase from baseline in time to complete the 9-HPT * Time to onset of 24-week CDP (CDP24) * Total number of T1Gd+ lesions as detected by MRI * Total number of new and/or enlarging T2-weighted lesions as detected by MRI * Rate of percent change in total brain volume from Week 24 as assessed by MRI * Change in patient-reported physical impacts of MS, as measured by the Multiple Sclerosis Impact Scale (29-Item), Version 2 (MSIS-29 v2) physical scale) * Time to onset of 12-week confirmed 4-point worsening in Symbol Digit Modalities Test (SDMT) score * Change from baseline to Week 48 in the concentration of serum neurofilament light chain (NfL) The secondary endpoints above do not reflect order of statistical hierarchy.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)