A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple Sclerosis

Conditions

Primary Progressive Multiple Sclerosis (PPMS)

Brief summary

1. Time to onset of composite 12-week confirmed disability progression (cCDP12)

Detailed description

1. Time to onset of composite 24 week CDP (cCDP24), 2. Time to onset of 12-week CDP (CDP12), 3. Time to onset of 24 week CDP (CDP24), 4. Percent change in total brain volume from Week 24 as assessed by MRI scan, 5. Percent change from screening to Week 120 in serum neurofilament light chain (NfL) levels, 6. Change patient-reported physical impacts of MS (as measured by Multiple Sclerosis Impact Scale, 29-Item [MSIS-29] physical scale), 7. Time to onset of 12 week confirmed 4 point worsening in Symbol Digit Modality Test (SDMT) score, 8. The nature, frequency, timing, and severity of adverse events; serious adverse events; and adverse events leading to study treatment withdrawal, 9. Change from baseline in targeted vital signs, 10. Change from baseline in targeted ECG parameters, 11. Change from baseline in clinical laboratory results following study treatment administration, 12. Change from baseline in the proportion of patients with suicidal ideation or behavior, as assessed by Columbia Suicide Severity Rating Scale (C-SSRS), 13. Plasma concentration of fenebrutinib at specified timepoints

Related papers

No related papers found yet.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Time to onset of composite 12-week confirmed disability progression (cCDP12)	—

Secondary

Measure	Time frame
1. Time to onset of composite 24 week CDP (cCDP24), 2. Time to onset of 12-week CDP (CDP12), 3. Time to onset of 24 week CDP (CDP24), 4. Percent change in total brain volume from Week 24 as assessed by MRI scan, 5. Percent change from screening to Week 120 in serum neurofilament light chain (NfL) levels, 6. Change patient-reported physical impacts of MS (as measured by Multiple Sclerosis Impact Scale, 29-Item [MSIS-29] physical scale), 7. Time to onset of 12 week confirmed 4 point worsening in Symbol Digit Modality Test (SDMT) score, 8. The nature, frequency, timing, and severity of adverse events; serious adverse events; and adverse events leading to study treatment withdrawal, 9. Change from baseline in targeted vital signs, 10. Change from baseline in targeted ECG parameters, 11. Change from baseline in clinical laboratory results following study treatment administration, 12. Change from baseline in the proportion of patients with suicidal ideation or behavior, as assessed by Columb	—

Measure

Time frame

1. Time to onset of composite 24 week CDP (cCDP24), 2. Time to onset of 12-week CDP (CDP12), 3. Time to onset of 24 week CDP (CDP24), 4. Percent change in total brain volume from Week 24 as assessed by MRI scan, 5. Percent change from screening to Week 120 in serum neurofilament light chain (NfL) levels, 6. Change patient-reported physical impacts of MS (as measured by Multiple Sclerosis Impact Scale, 29-Item [MSIS-29] physical scale), 7. Time to onset of 12 week confirmed 4 point worsening in Symbol Digit Modality Test (SDMT) score, 8. The nature, frequency, timing, and severity of adverse events; serious adverse events; and adverse events leading to study treatment withdrawal, 9. Change from baseline in targeted vital signs, 10. Change from baseline in targeted ECG parameters, 11. Change from baseline in clinical laboratory results following study treatment administration, 12. Change from baseline in the proportion of patients with suicidal ideation or behavior, as assessed by Columb

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Countries

Austria, Bulgaria, Denmark, France, Germany, Greece, Hungary, Italy, Poland, Portugal, Spain

Outcome results