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

Conditions

Relapsing multiple sclerosis (RMS)

Brief summary

1.Annualized relapse rate

Detailed description

1. Time to onset of cCDP12, 2. Time to onset of CDP12, 3. Time to onset of cCDP24, 4. Time to onset of CDP24, 5. Total number of gadolinium-enhancing lesions on T1-weighted MRI lesions as detected by MRI, 6. Total number of new and/or enlarging T2-weighted lesions as detected by MRI, 7. Rate of percent change in total brain volume from Week 24 as assessed by MRI, 8. Rate of change from baseline in patient-reported physical impacts of MS, as measured by the Multiple Sclerosis Impact Scale (29-Item), Version 2 (MSIS-29 v2) physical scale, 9. Time to onset of 12-week confirmed 4-point worsening in SDMT score, 10. Change from baseline to Week 48 in the concentration of bloodneurofilament light chain (NfL), 11. Composite 12-week confirmed progression independent of relapse activity (cPIRA12), 12. The nature, frequency, timing, and severity of adverse events; serious adverse events; and adverse events leading to study treatment discontinuation or dose interruptions, 13. Change from baseline in targeted vital signs, 14. Change from baseline in targeted ECG parameters, 15. Change from baseline in clinical laboratory results, 16. Proportion of patients with suicidal ideation or behavior, 17. Plasma concentration of fenebrutinib at specified timepoints

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGFenebrutinib Placebo

DRUGAUBAGIO 14 mg film-coated tablets

DRUGAubagio Placebo

DRUGFenebrutinib

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
1.Annualized relapse rate	—

Secondary

Measure	Time frame
1. Time to onset of cCDP12, 2. Time to onset of CDP12, 3. Time to onset of cCDP24, 4. Time to onset of CDP24, 5. Total number of gadolinium-enhancing lesions on T1-weighted MRI lesions as detected by MRI, 6. Total number of new and/or enlarging T2-weighted lesions as detected by MRI, 7. Rate of percent change in total brain volume from Week 24 as assessed by MRI, 8. Rate of change from baseline in patient-reported physical impacts of MS, as measured by the Multiple Sclerosis Impact Scale (29-Item), Version 2 (MSIS-29 v2) physical scale, 9. Time to onset of 12-week confirmed 4-point worsening in SDMT score, 10. Change from baseline to Week 48 in the concentration of bloodneurofilament light chain (NfL), 11. Composite 12-week confirmed progression independent of relapse activity (cPIRA12), 12. The nature, frequency, timing, and severity of adverse events; serious adverse events; and adverse events leading to study treatment discontinuation or dose interruptions, 13. Change from baseline	—

Measure

Time frame

1. Time to onset of cCDP12, 2. Time to onset of CDP12, 3. Time to onset of cCDP24, 4. Time to onset of CDP24, 5. Total number of gadolinium-enhancing lesions on T1-weighted MRI lesions as detected by MRI, 6. Total number of new and/or enlarging T2-weighted lesions as detected by MRI, 7. Rate of percent change in total brain volume from Week 24 as assessed by MRI, 8. Rate of change from baseline in patient-reported physical impacts of MS, as measured by the Multiple Sclerosis Impact Scale (29-Item), Version 2 (MSIS-29 v2) physical scale, 9. Time to onset of 12-week confirmed 4-point worsening in SDMT score, 10. Change from baseline to Week 48 in the concentration of bloodneurofilament light chain (NfL), 11. Composite 12-week confirmed progression independent of relapse activity (cPIRA12), 12. The nature, frequency, timing, and severity of adverse events; serious adverse events; and adverse events leading to study treatment discontinuation or dose interruptions, 13. Change from baseline

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Countries

Finland, Germany, Hungary, Italy, Poland, Portugal, Spain

Outcome results

None listed