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

Phase 2

Active, not recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Rosnilimab; Drug: Placebo

• Registration Number: NCT06041269
• Lead Sponsor: AnaptysBio, Inc.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2023-08-31
• Study First Submitted: 2023-09-11
• Study First Submitted QC: 2023-09-11
• Study First Posted: 2023-09-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2024-11-29
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 420

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosnilimab SC Dose 1	Rosnilimab	This arm will receive treatment SC
Placebo	Placebo	This arm will receive Placebo
Rosnilimab SC Dose 2	Rosnilimab	This arm will receive treatment SC
Rosnilimab SC Dose 3	Rosnilimab	This arm will receive treatment SC

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
American College of Rheumatology 20% Improvement Criteria (ACR20) response rate at Week 12	Baseline to Week 12
American College of Rheumatology 50% and 70% Improvement Criteria (ACR50 and ACR70) response rates at Week 12	Baseline to Week 12

Trial Locations

Locations (92)

AnaptysBio Investigative Site 20-106; 🇮🇹 Milan, Lombardy, Italy

AnaptysBio Investigative Site 20-110; 🇮🇹 Milan, Italy

AnaptysBio Investigative Site 10-132; 🇺🇸 Flagstaff, Arizona, United States

AnaptysBio Investigative Site 10-130; 🇺🇸 Glendale, Arizona, United States

AnaptysBio Investigative Site 10-129; 🇺🇸 Phoenix, Arizona, United States

AnaptysBio Investigative Site 10-131; 🇺🇸 Tucson, Arizona, United States

AnaptysBio Investigative Site 10-105; 🇺🇸 Covina, California, United States

Anaptys Bio Investigative Site 10-119; 🇺🇸 Rancho Mirage, California, United States

AnaptysBio Investigative Site 10-113; 🇺🇸 San Diego, California, United States

AnaptysBio Investigative Site 10-127; 🇺🇸 San Francisco, California, United States

AnaptysBio Investigative Site 10-136; 🇺🇸 Temecula, California, United States

AnaptysBio Investigative Site 10-133; 🇺🇸 Upland, California, United States

AnaptysBio Investigative Site 10-112; 🇺🇸 Whitter, California, United States

AnaptysBio Investigative Site 10-103; 🇺🇸 Aventura, Florida, United States

AnaptysBio Investigative Site 10-141; 🇺🇸 Avon Park, Florida, United States

AnaptysBio Investigative Site 10-118; 🇺🇸 Boynton Beach, Florida, United States

AnaptysBio Investigative Site 10-125; 🇺🇸 Daytona Beach, Florida, United States

AnaptysBio Investigative Site 10-122; 🇺🇸 Homestead, Florida, United States

Anaptys Bio Investigative Site 10-142; 🇺🇸 Miami, Florida, United States

AnaptysBio Investigative Site 10-140; 🇺🇸 Miami, Florida, United States

AnaptysBio Investigative Site 10-102; 🇺🇸 Miami, Florida, United States

AnaptysBio Investigative Site 10-124; 🇺🇸 Plantation, Florida, United States

AnaptysBio Investigative Site 10-139; 🇺🇸 West Palm Beach, Florida, United States

AnaptysBio Investigative Site 10-114; 🇺🇸 Chicago, Illinois, United States

AnaptysBio Investigative Site 10-145; 🇺🇸 Monroe, Louisiana, United States

AnaptysBio Investigative Site 10-143; 🇺🇸 Brookline, Massachusetts, United States

AnaptysBio Investigative Site 10-116; 🇺🇸 Albuquerque, New Mexico, United States

AnaptysBio Investigative Site 10-148; 🇺🇸 Smithfield, North Carolina, United States

AnaptysBio Investigative Site 10-146; 🇺🇸 Middleburg Heights, Ohio, United States

AnaptysBio Investigative Site 10-101; 🇺🇸 Jackson, Tennessee, United States

AnaptysBio Investigative Site 10-120; 🇺🇸 Allen, Texas, United States

AnaptysBio Investigative Site 10-107; 🇺🇸 Colleyville, Texas, United States

AnaptysBio Investigative Site 10-123; 🇺🇸 Katy, Texas, United States

AnaptysBio Investigative Site 10-108; 🇺🇸 Mesquite, Texas, United States

AnaptysBio Investigative Site 10-110; 🇺🇸 Plano, Texas, United States

AnaptysBio Investigative Site 10-106; 🇺🇸 The Woodlands, Texas, United States

AnaptysBio Investigative Site 10-121; 🇺🇸 Tomball, Texas, United States

AnaptysBio Investigative Site 10-117; 🇺🇸 Beckley, West Virginia, United States

AnaptysBio Investigative Site 13-102; 🇧🇪 Anderlecht, Bruxelles, Belgium

AnaptysBio Investigative Site 13-104; 🇧🇪 Leuven, Vlaams-Braba, Belgium

AnaptysBio Investigative Site 13-103; 🇧🇪 Antwerp, Belgium

AnaptysBio Investigative Site 13- 105; 🇧🇪 Liège, Belgium

AnaptysBio Investigative Site 11-104; 🇨🇦 Niagara Falls, Ontario, Canada

AnaptysBio Investigative Site 11-101; 🇨🇦 Windsor, Ontario, Canada

AnaptysBio Investigative Site 11-103; 🇨🇦 Trois-Rivières, Quebec, Canada

AnaptysBio Investigative Site 71-103; 🇪🇪 Tartu, Tartumaa, Estonia

AnaptysBio Investigative Site 71-102; 🇪🇪 Tallinn, Estonia

AnaptysBio Investigative Site 71-101; 🇪🇪 Tallinn, Estonia

AnaptysBio Investigative Site 16-105; 🇫🇷 Cahors, France

AnaptysBio Investigative Site 16-101; 🇫🇷 Montpellier, France

AnaptysBio Investigative Site 16-102; 🇫🇷 Toulouse cedex 9, France

AnaptysBio Investigative Site 59-101; 🇬🇪 Tbilisi, Georgia

AnaptysBio Investigative Site 59-106; 🇬🇪 Tbilisi, Georgia

AnaptysBio Investigative Site 59-105; 🇬🇪 Tbilisi, Georgia

AnaptysBio Investigative Site 59-104; 🇬🇪 Tbilisi, Georgia

AnaptysBio Investigative Site 59-102; 🇬🇪 Tbilisi, Georgia

AnaptysBio Investigative Site 59-103; 🇬🇪 Tbilisi, Georgia

AnaptysBio Investigative Site 17-103; 🇩🇪 Berlin, Germany

AnaptysBio Investigative Site 17-102; 🇩🇪 Hamburg, Germany

AnaptysBio Investigative Site 17-107; 🇩🇪 Hanover, Germany

AnaptysBio Investigative Site 17-105; 🇩🇪 Herne, Germany

AnaptysBio Investigative Site 28-103; 🇭🇺 Debrecen, Hajdu-Bihar, Hungary

AnaptysBio Investigative Site 28-101; 🇭🇺 Budapest, Pest, Hungary

Anaptys Bio Investigative Site 28-106; 🇭🇺 Budapest, Hungary

AnaptysBio Investigative Site 28-104; 🇭🇺 Budapest, Hungary

AnaptysBio Investigative Site 20-101; 🇮🇹 Pavia, PV, Italy

AnaptysBio Investigative Site 20-104; 🇮🇹 Bari, Italy

AnaptysBio Investigative Site 20-105; 🇮🇹 Novara, Italy

AnaptysBio Investigative Site 20-108; 🇮🇹 Roma, Italy

AnaptysBio Investigative Site73-101; 🇲🇩 Chisinau, Kishinev, Moldova, Republic of

AnaptysBio Investigative Site 30-104; 🇵🇱 Toruń, Kuj-pom, Poland

AnaptysBio Investigative Site 30-103; 🇵🇱 Nowa Sól, Lubuskie, Poland

AnaptysBio Investigative Site 30-107; 🇵🇱 Warsaw, Mazowieckie, Poland

AnaptysBio Investigative Site 30-106; 🇵🇱 Opole, Opolskie, Poland

AnaptysBio Investigative Site 30-112; 🇵🇱 Poznań, Wielkopolskie, Poland

AnaptysBio Investigative Site 30-105; 🇵🇱 Poznań, Wielkopolskie, Poland

AnaptysBio Investigative Site 30-101; 🇵🇱 Poznań, Wielkopolskie, Poland

AnaptysBio Investigative Site 30-102; 🇵🇱 Bytom, Woj.Slaskie, Poland

AnaptysBio Investigative Site 30-111; 🇵🇱 Białystok, Poland

AnaptysBio Investigative Site 30-109; 🇵🇱 Bydgoszcz, Poland

AnaptysBio Investigative Site 30-108; 🇵🇱 Warsaw, Poland

AnaptysBio Investigative Site 67-101; 🇸🇰 Košice, Slovakia

AnaptysBio Investigative Site 67-102; 🇸🇰 Martin, Slovakia

AnaptysBio Investigative Site 67-103; 🇸🇰 Piešťany, Slovakia

AnaptysBio Investigative Site 24-101; 🇪🇸 Bilbao, Bizkaia, Spain

AnaptysBio Investigative Site 24-102; 🇪🇸 Santiago de Compostela, Coruna, Spain

AnaptysBio Investigative Site 24-105; 🇪🇸 Córdoba, Spain

AnaptysBio Investigative Site 24-104; 🇪🇸 Santiago De Compostela, Spain

AnaptysBio Investigative Site 24-103; 🇪🇸 Santiago De Compostela, Spain

AnaptysBio Investigative Site 34-101; 🇺🇦 Kyiv, Ukraine

AnaptysBio Investigative Site 27-101; 🇬🇧 London, United Kingdom

AnaptysBio Investigative Site 27-102; 🇬🇧 Manchester, United Kingdom