A study to assess if Fenebrutinib compared with Teriflunomide is safe and effective in adult patients with relapsing multiple sclerosis.

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/031904

Enrollment

736

Registered

2021-03-11

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G00-G09- Inflammatory diseases of the central nervous system

Interventions

Intervention1: Fenebrutinib: 200 mg by mouth [PO] BID for minimum 96 weeks Intervention2: Teriflunomide: 14 mg PO QD for minimum 96 weeks Control Intervention1: Placebo of teriflunomide: 14 mg PO QD f

Eligibility

Inclusion criteria

Inclusion criteria: Informed Consent Age 18-55 years inclusive Ability to comply with the study protocol EDSS score of 0-5.5 at screening Neurologically stable for at least 30 days prior to randomization and baseline assessments Ability to complete the 9-HPT for each hand in Ability to perform the T25FWT in <150 seconds

Exclusion criteria

Exclusion criteria: Disease duration of >10 years from the onset of symptoms and an EDSS score at screening Pregnant or breastfeeding A diagnosis of PPMS or non-active SPMS History of confirmed or suspected progressive multifocal leukoencephalopathy (PML) History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening Adds explicit exclusion for patients at risk of suicide

Design outcomes

Primary

Measure	Time frame
The primary efficacy objective for this study is to evaluate the efficacy of fenebrutinib compared with teriflunomideTimepoint: Annualized relapse rate (ARR)	—

Secondary

Measure	Time frame
evaluate the efficacy of fenebrutinib treatment compared with teriflunomideTimepoint: 1. Time to onset of composite 12-week confirmed disability progression (cCDP12), defined as the time from baseline to the first occurrence of a progression event 2. Time to onset of composite 24-week confirmed disability progression (cCDP24)	—

Countries

Austria, Belgium, Brazil, Bulgaria, Canada, Denmark, France, Greece, India, Italy, Mexico, Poland, Republic of Korea, Russian Federation, Turkey, United Kingdom, United States of America

Contacts

Public ContactRashmin Shukla

Roche Products (India) Pvt. Ltd.

jyotii.poddaar@roche.com9136064373

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026