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Active, not recruiting Phase 2

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

NCT06041269 · tracked via the Priya Life Science France tracker
Sponsor
AnaptysBio, Inc
Phase
Phase 2
Started
2023-08-31
Last updated
2024-11-25

Condition(s) studied

Rheumatoid Arthritis

Investigational drug(s) / intervention(s)

Rosnilimab →Placebo

Rosnilimab: PD-1 agonist antibody

Placebo: Placebo

Study summary

RENOIR Study: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe Rheumatoid Arthritis (RA)

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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

Primary outcome measure(s)

  • Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12 — Baseline to Week 12
    The DAS28-CRP is a validated composite assessment that assesses RA disease activity based on tender and swollen joint counts of 28 joints

Trial sites (92)

FacilityCityRegionStatus
AnaptysBio Investigative Site 10-132 Flagstaff Arizona
AnaptysBio Investigative Site 10-130 Glendale Arizona
AnaptysBio Investigative Site 10-129 Phoenix Arizona
AnaptysBio Investigative Site 10-131 Tucson Arizona
AnaptysBio Investigative Site 10-105 Covina California
Anaptys Bio Investigative Site 10-119 Rancho Mirage California
AnaptysBio Investigative Site 10-113 San Diego California
AnaptysBio Investigative Site 10-127 San Francisco California
AnaptysBio Investigative Site 10-136 Temecula California
AnaptysBio Investigative Site 10-133 Upland California
AnaptysBio Investigative Site 10-112 Whitter California
AnaptysBio Investigative Site 10-103 Aventura Florida
AnaptysBio Investigative Site 10-141 Avon Park Florida
AnaptysBio Investigative Site 10-118 Boynton Beach Florida
AnaptysBio Investigative Site 10-125 Daytona Beach Florida
AnaptysBio Investigative Site 10-122 Homestead Florida
Anaptys Bio Investigative Site 10-142 Miami Florida
AnaptysBio Investigative Site 10-140 Miami Florida
AnaptysBio Investigative Site 10-102 Miami Florida
AnaptysBio Investigative Site 10-124 Plantation Florida
AnaptysBio Investigative Site 10-139 West Palm Beach Florida
AnaptysBio Investigative Site 10-114 Chicago Illinois
AnaptysBio Investigative Site 10-145 Monroe Louisiana
AnaptysBio Investigative Site 10-143 Brookline Massachusetts
AnaptysBio Investigative Site 10-116 Albuquerque New Mexico
AnaptysBio Investigative Site 10-148 Smithfield North Carolina
AnaptysBio Investigative Site 10-146 Middleburg Heights Ohio
AnaptysBio Investigative Site 10-101 Jackson Tennessee
AnaptysBio Investigative Site 10-120 Allen Texas
AnaptysBio Investigative Site 10-107 Colleyville Texas
AnaptysBio Investigative Site 10-123 Katy Texas
AnaptysBio Investigative Site 10-108 Mesquite Texas
AnaptysBio Investigative Site 10-110 Plano Texas
AnaptysBio Investigative Site 10-106 The Woodlands Texas
AnaptysBio Investigative Site 10-121 Tomball Texas
AnaptysBio Investigative Site 10-117 Beckley West Virginia
AnaptysBio Investigative Site 13-102 Anderlecht Brussels Capital
AnaptysBio Investigative Site 13- 105 Liège Liège
AnaptysBio Investigative Site 13-104 Leuven Vlaams-Braba
AnaptysBio Investigative Site 13-103 Antwerp Belgium

+ 52 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06041269 on ClinicalTrials.gov ↗ ← All trials in France