Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Rheumatoid Arthritis
Research type
Research Study
Full title
A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate\nto Severe Rheumatoid Arthritis
IRAS ID
1008151
Contact name
Frances Humby
Contact email
Sponsor organisation
AnaptysBio, Inc.
Eudract number
2023-504564-42
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to evaluate if the study drug, rosnilimab is effective, tolerable and safe as an add-on therapy in participants with moderate to severe rheumatoid arthritis (RA) who did not get better from prior treatment(s).\nAbout 1 in every 200 adults are affected by RA worldwide. Untreated RA can seriously affect one’s work and life, and possibly lead to serious outcomes such as joint surgery and even death. Rosnilimab is a new treatment under investigation for people who didn’t feel better with the standard therapies.\nThe study comprises of screening period up to 35 days, first treatment period of 12 weeks, second treatment period of 12 weeks followed by a follow-up period of 12 weeks. So, in total your participation in the study may last up to 43 weeks (about 10.75 months). Approximately 420 people aged 18 and over with RA will participate in the study.\nDuring the trial participants undergo chest x-ray, ECG, physical examination, blood and urine samples collection to conduct tests as described in the information sheet.
REC name
London - City & East Research Ethics Committee
REC reference
24/LO/0203
Date of REC Opinion
17 Apr 2024
REC opinion
Further Information Favourable Opinion