GN42272 - STUDY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN PATIENTS WITH RMS
Research type
Research Study
Full title
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
IRAS ID
1003570
Contact name
Nazar Sharaf
Contact email
Sponsor organisation
Genentech, Inc
Eudract number
2020-001168-28
Research summary
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating, and degenerative
disease of the CNS that affects approximately 2.3 million worldwide. It is primarily a
disease of young adults, with 70%−80% of patients having an age of onset between 20
and 40 years with approximately up to 64%−70% of diagnosed patients being women.
The symptoms of MS worsen over time and the progression of the results are a slow loss
of the patients motor and sensory functions as well as cognitive decline and autonomic
dysfunctions.
Even though there are many drugs currently available that target the inflammation
associated with relapses and relapse associated worsening, to date, only ocrelizumab is
indicated for Relapsing Multiple Sclerosis (RMS). As a result, the progression in all
forms of MS remains under addressed, and treatments that can stop or delay MS disease
progression represent a serious unmet medical need
The purpose of this study is to compare the effects, good or bad, of fenebrutinib versus
teriflunomide in adult patients with RRMS and active secondary progressive MS,
collectively referred to as RMS. All eligible patients will be randomized to either one of
two arms:
- Fenebrutinib treatment arm: fenebrutinib (200 mg by mouth twice a day) with
teriflunomide-matching placebo
- Teriflunomide treatment arm: teriflunomide (14 mg by mouth 4 times a day) with
fenebrutinib-matching placebo in a blinded fashion
A placebo looks like a drug but has no active ingredient
Patients will be on the study for approximately three and half years
In total, about 1468 people will take part in this study and in the identical sister study
(GN41851). Approximately 16 participants will take part in the UK
The study is sponsored by F. Hoffman La Roche
Research Summary; Version Number 1 and 09-Dec-2020;REC name
East of Scotland Research Ethics Service REC 2
REC reference
21/ES/0009
Date of REC Opinion
24 Feb 2021
REC opinion
Further Information Favourable Opinion