Clinical Trials in France / NCT06041269
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More AnaptysBio, Inc. trials in France
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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