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Clinical Trials/2022-502609-14-00
2022-502609-14-00
Active, not recruiting
Phase 3

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

F. Hoffmann-La Roche AG51 sites in 7 countries214 target enrollmentStarted: July 18, 2024Last updated:
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Overview

Phase
Phase 3
Status
Active, not recruiting
Enrollment
214
Locations
51
Primary Endpoint
1.Annualized relapse rate
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To evaluate the efficacy of fenebrutinib compared with teriflunomide on the basis of annualized relapse rate (ARR)

Eligibility Criteria

Ages
18 years to 64 years (18-64 Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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 < 240 seconds
  • •Ability to perform the timed 25-Foot Walk Test in <150 seconds
  • •OLE Inclusion Criteria: Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the opinion of the investigator, may benefit from treatment with fenebrutinib

Exclusion Criteria

  • •A diagnosis of PPMS or non-active secondary progressive Multiple sclerosis (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. Onychomycosis is not exclusionary unless it is being treated with systemic therapy
  • •History of cancer including hematologic malignancy and solid tumors within 10 years of screening
  • •Known presence of other neurological disorders that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study, clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease
  • •Any concomitant disease that may require chronic treatment with systemic corticosteroids, or immunosuppressants during the course of the study

Outcomes

Primary Outcomes

1.Annualized relapse rate

1.Annualized relapse rate

Secondary Outcomes

  • 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

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Trial Information System - TISL

Scientific

F. Hoffmann-La Roche AG

Study Sites (51)

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