Last updated 2 years ago

A Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Rheumatoid Arthritis (RENOIR)

420 patients around the world

Available in United States, Mexico, Peru, Argentina

This study is a Phase 2 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis.

AnaptysBio, Inc.

420Patients around the world

This study is for people with

Arthritis

Rheumatoid arthritis

Requirements for the patient

To 65 Years

All Gender

Medical requirements

: Aged 18 years or older
A diagnosis of Rheumatoid Arthritis based on ACR/EULAR 2010 classification criteria, for at least 3 months before participating in the trial
Must be receiving treatment with at least 1, but not more than 2 csDMARDs for at least 3 months and be on stable dosages for at least 8 weeks prior to joining and throughout the trial
Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD (bDMARD), or targeted synthetic DMARD (tsDMARD) treatment

: History of an inflammatory joint disease other than Rheumatoid Arthritis
Prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator
History of cancer within the last 5 years (except for some skin cancers)
Any known or suspected condition that would compromise immune status
Pregnant or breastfeeding women

SponsorAnaptysBio, Inc.

Conditions

Rheumatoid arthritis

Requirements

To 65 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06041269