An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants with Rheumatoid Arthritis
Research type
Research Study
Full title
An Adaptive Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants with Moderately-to-Severely Active Rheumatoid Arthritis.
IRAS ID
1007444
Contact name
EU Clinical Trials
Contact email
Sponsor organisation
Eli Lilly and Company Limited
Eudract number
2022-502994-40
Research summary
Rheumatoid arthritis (RA) is a common, autoimmune inflammatory disease characterised by inflammation leading to pain, swelling, stiffness, and progressive destruction and deformity of small and large joints. Patients experience impaired physical function, social participation, and health-related quality of life.
Current expert recommendations for treatment of RA include prompt initiation and dosage modifications of specific therapies to bring patients to a level of low disease activity (LDA) or disease remission. Achieving these targets improves short- and long-term patient health outcomes, including prevention of progressive, irreversible structural joint damage. Low disease activity can be met in most patients with the therapeutic options that are currently available. However, 20% to 30% of patients with RA fail to respond to current therapies, and for these patients, new treatment options are needed.
LY3871801 is a medicine that helps to block the inflammation that can lead to certain diseases. It is being developed as an oral option for the potential treatment of autoimmune and inflammatory disorders, such as psoriasis, RA, and inflammatory bowel disease. This study is taking place internationally and there will be about 100 participants in the 2a portion and 280 in the subsequent 2b portion.
Approximately 8 patients will be from the UK, and participation will last 38 weeks. In this study we are trying to understand the safety and efficacy of different doses of LY3871801 to treat moderately-to-severely active RA in patients, compared with a placebo.
Participants in this study may benefit by receiving personal health information and other routine safety assessments performed in this study.REC name
East Midlands - Derby Research Ethics Committee
REC reference
23/EM/0126
Date of REC Opinion
17 Oct 2023
REC opinion
Further Information Favourable Opinion