GN41791 Fenebrutinib compared with Ocrelizumab in patients with PP MS
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 OCRELIZUMAB IN ADULT PATIENTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS
IRAS ID
281231
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division, PDR
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2019-003919-53
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
7 years, 2 months, 31 days
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.
Progressive forms of MS (PMS) are associated with a chronic and slow accumulation of T cells and B cells.
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 Primary Progressive Multiple Scelerosis (PPMS). 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.
Mutations in the gene for Bruton’s tyrosine kinase (BTK) can affect the activity of B cells during a normal adaptive immune response. Fenebrutinib is a highly selective, orally administered, reversible inhibitor of BTK that is being developed as a potential therapeutic agent for MS and other autoimmune diseases.Cell-based experiments suggest that antagonism of BTK with fenebrutinib leads to inhibition of BCR-dependent B-cell proliferation and a reduction of inflammatory cytokine production from myeloid cells.
This Phase III study will explore the efficacy and safety of fenebrutinib compared with ocrelizumab in adult patients with PPMS.
There will be approximately 35 patients recruited at 9 UK sites
The study is sponsored by F. Hoffman La Roche
Research Summary; Version Number 1 dated 5th March 2020;
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0277
Date of REC Opinion
3 Aug 2020
REC opinion
Favourable Opinion