Relapsing multiple sclerosis (RMS) MedDRA version: 20.0 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0 Level: PT Classification code 10080700 Term: Relapsing multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: fenebrutinib
Product Code: RO7010939
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: FENEBRUTINIB
Current Sponsor code: RO7010939
Concentration unit: mg milligram(s)
Concent
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
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 =65 years) no F.1.3.1 Number of subjects for this age range
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 < 2.0 • Any known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti-microbials within 8 weeks prior to and during screening or treatment with oral anti-microbials within 2 weeks prior to and during screening • History of cancer including hematologic malignancy and solid tumors within 10 years of screening. • Known presence of other neurological disorders, clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease • Any concomitant disease that may require chronic treatment with systemic corticosteroids, immunosuppressants during the course of the study • History of alcohol or other drug abuse within 12 months prior to screening • Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period • Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization • Female participants who are pregnant or breastfeeding or intending to become pregnant during the study or 8 weeks (with ATEP) after final dose of study drug • Male participants intending to father a child during the study or 8 weeks (with ATEP) after final dose of study drug • Severe hepatic disease impairment (Child-Pugh Class C) or Gilbert's Syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of fenebrutinib compared with teriflunomide on the basis of time to onset of composite 12-week confirmed disability progression (cCDP12) and annualized relapse rate (ARR);Secondary Objective: • To evaluate the efficacy of fenebrutinib treatment compared with teriflunomide on the basis of time to onset of composite 24-week confirmed composite disability progression (cCDP24), time to onset of composite 12-week confirmed disability progression (cCDP12), time to onset of 12-week confirmed disability progression (CDP12), time to onset of 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, 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) • To evaluate the safety of fenebrutinib compared with teriflunomide • To characterize the fenebrutinib pharmacokinetics profile;Primary end point(s): 1. Annualized relapse rate ;Timepoint(s) of evaluation of this end point: 1. 96 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 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 serum neurofilament light chain (NfL) 11. The nature, frequency, timing, and severity of adverse events; serious adverse events; and adverse events leading to study treatment discontinuation or dose interruptions 12. Change from baseline in targeted vital signs 13. Change from baseline in targeted ECG parameters 14. Change from baseline in clinical laboratory results 15. Proportion of patients with suicidal ideation or behavior 16. Plasma concentration of fenebrutinib at specified timepoints;Timepoint(s) of evaluation of this end point: 1-2. Time from baseline to the first occurrence of a progression event and must be confirmed at least 12 weeks after the initial disability progression 3-4. Time from baseline to first occurrence of a progression event and must be confirmed at least 24 weeks after initial disability progression 5-6. Timepoints up to primary analysis 7. Week 24 to Week 96 8. At baseline, Week 12, 24, 36, 48, 60, 72, 84, 96 9. Time from baseline to first occurrence of 4-point worsening in SDMT event and must be confirmed at least 12 weeks after the initial event 10. Baseline to Week 48 11. Baseline to primary analysis 12-15. From baseline to primary analysis 16. Week 4, 12, 24, 48, 72, 96 and at treatment discontinuation, unscheduled visit | — |
Countries
Finland, France, Germany, Hungary, Italy, Netherlands, Portugal, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed