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Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)

NCT04586023 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 751

Last updated 2026-03-16

No results posted yet for this study

Summary

A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized in a 1:1 ratio to receive either fenebrutinib or teriflunomide. At the end of the double-blind treatment (DBT) phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension (OLE) phase of the study.

Conditions

Interventions

DRUG

Teriflunomide

Participants will receive teriflunomide.

DRUG

Placebo

Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.

DRUG

Fenebrutinib

Participants will receive fenebrutinib.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-24
Primary Completion
2025-09-05
Completion
2027-07-09
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Brazil
  • Bulgaria
  • Canada
  • Denmark
  • France
  • Greece
  • Guatemala
  • India
  • Italy
  • Mexico
  • Poland
  • Russia
  • South Korea
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04586023 on ClinicalTrials.gov