fenebrutinib for Sclerosis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Sclerosis+2 More
fenebrutinib - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a new drug, fenebrutinib, is better than the current standard of care, teriflunomide, at slowing disability progression and relapse rate in people with RMS.

Eligible Conditions
  • Sclerosis
  • Multiple Sclerosis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Sclerosis

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: Up to 3.5 years

Week 12
Multiple Sclerosis
Change in Participant-Reported Physical Impacts of Multiple Sclerosis (MS)
Week 12
Total Number of T1Gd+ lesions, new and/or enlarging T2-weighted lesions as detected by MRI
Week 96
Percentage Change in Total Brain Volume from Week 24 as assessed by MRI
Minimum of 96 weeks
Annualized Relapse Rate (ARR)
Time to onset of 12-week confirmed 4-point worsening in Symbol Digit Modality Test (SDMT) score
Time to onset of 12-week confirmed disability progression (CDP12)
Time to onset of 24-week confirmed disability progression (CDP24)
Time to onset of composite 12-week confirmed disability progression (cCDP12)
Time to onset of composite 24-week confirmed disability progression (cCDP24)
Up to 3.5 years
Percentage of Participants with Adverse Events (AEs)
Plasma Concentrations of fenebrutinib at specified timepoints
Up to 48 weeks
Change from Baseline to Week 48 in the Concentration of Serum Neurofilament Light chain (NfL)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Sclerosis

Trial Design

2 Treatment Groups

teriflunomide
1 of 2
fenebrutinib
1 of 2
Active Control
Experimental Treatment

736 Total Participants · 2 Treatment Groups

Primary Treatment: fenebrutinib · Has Placebo Group · Phase 3

fenebrutinibExperimental Group · 2 Interventions: fenebrutinib, placebo · Intervention Types: Drug, Drug
teriflunomideActiveComparator Group · 2 Interventions: teriflunomide, placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
placebo
2010
Completed Phase 4
~6450

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3.5 years

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,351 Previous Clinical Trials
1,093,355 Total Patients Enrolled
33 Trials studying Sclerosis
17,532 Patients Enrolled for Sclerosis
Clinical TrialsStudy DirectorHoffmann-La Roche
2,131 Previous Clinical Trials
900,930 Total Patients Enrolled
36 Trials studying Sclerosis
17,713 Patients Enrolled for Sclerosis

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have an expanded disability status scale (EDSS) score of 0 - 5.5 at screening.
You have a diagnosis of RMS in accordance with the revised 2017 McDonald Criteria.
You are able to complete the 9-Hole Peg Test for each hand in < 240 seconds.
You are able to walk 25 feet in less than 150 seconds.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: October 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Missouri100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Kansas Medical Center100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%