*LY3462817 in Participants with moderate to severe Rheumatoid Arthritis
Research type
Research Study
Full title
A Phase 2 Study to Evaluate the Efficacy and Safety of LY3462817 in Participants with Moderately to Severely Active Rheumatoid Arthritis
IRAS ID
290481
Contact name
Paul Emery
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2020-002673-10
Duration of Study in the UK
1 years, 6 months, 19 days
Research summary
Rheumatoid Arthritis is an auto-immune disease. It is a condition that causes pain, swelling and stiffness in the joints, which can lead to the destruction and deformity of small and large joints.
Current treatment for RA involves the modification of disease-modifying antirheumatic drugs (DMARDs) to bring patients to a target of low disease activity (LDA) or remission. Patient treatment usually begins with oral conventional synthetic DMARDs (csDMARDs) but if LDA is not achieved, patients receive additional therapy with biologic DMARDs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs). However, 20 to 30% of RA patients are still resistant to these therapies.
LY3462817 is a humanized immunoglobulin (Ig) G1 monoclonal antibody that binds to and is an agonist to human programmed cell death protein 1 (PD-1). LY3462817 binding to PD-1 is expected to stimulate the physiological immune inhibitory pathway to restore immune regulation; this constitutes a novel approach to treat patients with autoimmune or auto-inflammatory diseases.This study will evaluate the efficacy of LY3462817 in adult patients with moderately to severely active RA who have had a poor response to either csDMARDs or to bDMARDs/tsDMARDs.
Participation in the study will be 9 to 10 months. There will be about 80 patients around the world taking part, including 11 from the UK.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
22/NE/0148
Date of REC Opinion
8 Mar 2021
REC opinion
Further Information Favourable Opinion