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

NCT06041269 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: ANB030-203
• Study Type: interventional
• Target: 420
• Locations: 14 countries
• Sites: 89

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

PD-1 Agonist; ANB030; RENOIR; Rosnilimab

Outcome Measures

Primary Outcomes (1)

• Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at 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

  Baseline to Week 12

Secondary Outcomes (2)

• 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

Study Arms (4)

Rosnilimab SC Dose 1

EXPERIMENTAL

This arm will receive treatment SC

Drug: Rosnilimab

Rosnilimab SC Dose 2

EXPERIMENTAL

This arm will receive treatment SC

Drug: Rosnilimab

Rosnilimab SC Dose 3

EXPERIMENTAL

This arm will receive treatment SC

Drug: Rosnilimab

Placebo

PLACEBO COMPARATOR

This arm will receive Placebo

Drug: Placebo

Interventions

Rosnilimab DRUG

PD-1 agonist antibody

Also known as: ANB030

Rosnilimab SC Dose 1; Rosnilimab SC Dose 2; Rosnilimab SC Dose 3

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AnaptysBio, Inc.: lead

Study Sites (92)

AnaptysBio Investigative Site 10-132

Flagstaff, Arizona, 86001, United States

Location

AnaptysBio Investigative Site 10-130

Glendale, Arizona, 85306, United States

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AnaptysBio Investigative Site 10-129

Phoenix, Arizona, 85037, United States

Location

AnaptysBio Investigative Site 10-131

Tucson, Arizona, 85704, United States

Location

AnaptysBio Investigative Site 10-105

Covina, California, 91722, United States

Location

Anaptys Bio Investigative Site 10-119

Rancho Mirage, California, 92270, United States

Location

AnaptysBio Investigative Site 10-113

San Diego, California, 92108, United States

Location

AnaptysBio Investigative Site 10-127

San Francisco, California, 94123, United States

Location

AnaptysBio Investigative Site 10-136

Temecula, California, 92592, United States

Location

AnaptysBio Investigative Site 10-133

Upland, California, 91786, United States

Location

AnaptysBio Investigative Site 10-112

Whitter, California, 90602, United States

Location

AnaptysBio Investigative Site 10-103

Aventura, Florida, 33180, United States

Location

AnaptysBio Investigative Site 10-141

Avon Park, Florida, 33825, United States

Location

AnaptysBio Investigative Site 10-118

Boynton Beach, Florida, 33436, United States

Location

AnaptysBio Investigative Site 10-125

Daytona Beach, Florida, 32117, United States

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AnaptysBio Investigative Site 10-122

Homestead, Florida, 33032, United States

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Anaptys Bio Investigative Site 10-142

Miami, Florida, 33125, United States

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AnaptysBio Investigative Site 10-140

Miami, Florida, 33126, United States

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AnaptysBio Investigative Site 10-102

Miami, Florida, 33155, United States

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AnaptysBio Investigative Site 10-124

Plantation, Florida, 33324, United States

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AnaptysBio Investigative Site 10-139

West Palm Beach, Florida, 33407, United States

Location

AnaptysBio Investigative Site 10-114

Chicago, Illinois, 60640, United States

Location

AnaptysBio Investigative Site 10-145

Monroe, Louisiana, 71203, United States

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AnaptysBio Investigative Site 10-143

Brookline, Massachusetts, 02445, United States

Location

AnaptysBio Investigative Site 10-116

Albuquerque, New Mexico, 87102, United States

Location

AnaptysBio Investigative Site 10-148

Smithfield, North Carolina, 27577, United States

Location

AnaptysBio Investigative Site 10-146

Middleburg Heights, Ohio, 44130, United States

Location

AnaptysBio Investigative Site 10-101

Jackson, Tennessee, 38305, United States

Location

AnaptysBio Investigative Site 10-120

Allen, Texas, 75013, United States

Location

AnaptysBio Investigative Site 10-107

Colleyville, Texas, 76034, United States

Location

AnaptysBio Investigative Site 10-123

Katy, Texas, 77450, United States

Location

AnaptysBio Investigative Site 10-108

Mesquite, Texas, 75150, United States

Location

AnaptysBio Investigative Site 10-110

Plano, Texas, 75024, United States

Location

AnaptysBio Investigative Site 10-106

The Woodlands, Texas, 77382, United States

Location

AnaptysBio Investigative Site 10-121

Tomball, Texas, 77375, United States

Location

AnaptysBio Investigative Site 10-117

Beckley, West Virginia, 25801, United States

Location

AnaptysBio Investigative Site 13-102

Anderlecht, Brussels Capital, 1070, Belgium

Location

AnaptysBio Investigative Site 13- 105

Liège, Liège, 4000, Belgium

Location

AnaptysBio Investigative Site 13-104

Leuven, Vlaams-Braba, 3000, Belgium

Location

AnaptysBio Investigative Site 13-103

Antwerp, 2170, Belgium

Location

AnaptysBio Investigative Site 11-104

Niagara Falls, Ontario, L2E6A6, Canada

Location

AnaptysBio Investigative Site 11-101

Windsor, Ontario, N8X1T3, Canada

Location

AnaptysBio Investigative Site 11-103

Trois-Rivières, Quebec, G9A 3Y2, Canada

Location

AnaptysBio Investigative Site 71-102

Tallinn, Estonia, 10117, Estonia

Location

AnaptysBio Investigative Site 71-101

Tallinn, Estonia, 13419, Estonia

Location

AnaptysBio Investigative Site 71-103

Tartu, Tartu, 50106, Estonia

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AnaptysBio Investigative Site 16-105

Cahors, 46000, France

Location

AnaptysBio Investigative Site 16-101

Montpellier, 34090, France

Location

AnaptysBio Investigative Site 16-102

Toulouse, 31059, France

Location

AnaptysBio Investigative Site 59-101

Tbilisi, 0112, Georgia

Location

AnaptysBio Investigative Site 59-105

Tbilisi, 0131, Georgia

Location

AnaptysBio Investigative Site 59-104

Tbilisi, 0159, Georgia

Location

AnaptysBio Investigative Site 59-106

Tbilisi, 0159, Georgia

Location

AnaptysBio Investigative Site 59-102

Tbilisi, 0160, Georgia

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AnaptysBio Investigative Site 59-103

Tbilisi, 0172, Georgia

Location

AnaptysBio Investigative Site 17-103

Berlin, 12161, Germany

Location

AnaptysBio Investigative Site 17-102

Hamburg, 20095, Germany

Location

AnaptysBio Investigative Site 17-107

Hanover, 30159, Germany

Location

AnaptysBio Investigative Site 17-105

Herne, 44649, Germany

Location

AnaptysBio Investigative Site 28-104

Budapest, Budapest, 1036, Hungary

Location

AnaptysBio Investigative Site 28-103

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

AnaptysBio Investigative Site 28-101

Budapest, Pest County, 1023, Hungary

Location

Anaptys Bio Investigative Site 28-106

Budapest, 1036, Hungary

Location

AnaptysBio Investigative Site 20-106

Milan, Lombardy, 20162, Italy

Location

AnaptysBio Investigative Site 20-101

Pavia, PV, 27100, Italy

Location

AnaptysBio Investigative Site 20-104

Bari, 70124, Italy

Location

AnaptysBio Investigative Site 20-110

Milan, 20122, Italy

Location

AnaptysBio Investigative Site 20-105

Novara, 28100, Italy

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AnaptysBio Investigative Site 20-108

Roma, 128, Italy

Location

AnaptysBio Investigative Site73-101

Chisinau, Kishinev, MD-2025, Moldova

Location

AnaptysBio Investigative Site 30-112

Poznan, Greater Poland Voivodeship, 60693, Poland

Location

AnaptysBio Investigative Site 30-105

Poznan, Greater Poland Voivodeship, 61-113, Poland

Location

AnaptysBio Investigative Site 30-101

Poznan, Greater Poland Voivodeship, 61-293, Poland

Location

AnaptysBio Investigative Site 30-104

Torun, Kuj-pom, 87-100, Poland

Location

AnaptysBio Investigative Site 30-103

Nowa Sól, Lubusz Voivodeship, 67-100, Poland

Location

AnaptysBio Investigative Site 30-107

Warsaw, Masovian Voivodeship, 02-118, Poland

Location

AnaptysBio Investigative Site 30-106

Opole, Opole Voivodeship, 45-819, Poland

Location

AnaptysBio Investigative Site 30-102

Bytom, Woj.Slaskie, 41-902, Poland

Location

AnaptysBio Investigative Site 30-111

Bialystok, 15-707, Poland

Location

AnaptysBio Investigative Site 30-109

Bydgoszcz, 85-065, Poland

Location

AnaptysBio Investigative Site 30-108

Warsaw, 00-874, Poland

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AnaptysBio Investigative Site 67-101

Košice, Slovakia, 4011, Slovakia

Location

AnaptysBio Investigative Site 67-102

Martin, 03601, Slovakia

Location

AnaptysBio Investigative Site 67-103

Piešťany, 92101, Slovakia

Location

AnaptysBio Investigative Site 24-101

Bilbao, Bizkaia, 48013, Spain

Location

AnaptysBio Investigative Site 24-102

Santiago de Compostela, Coruna, 15895, Spain

Location

AnaptysBio Investigative Site 24-105

Córdoba, 14004, Spain

Location

AnaptysBio Investigative Site 24-104

Santiago de Compostela, 15702, Spain

Location

AnaptysBio Investigative Site 24-103

Santiago de Compostela, 15706, Spain

Location

AnaptysBio Investigative Site 34-101

Kyiv, 01135, Ukraine

Location

AnaptysBio Investigative Site 27-101

London, IG14HP, United Kingdom

Location

AnaptysBio Investigative Site 27-102

Manchester, M278FF, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: August 31, 2023
• Primary Completion: November 29, 2024
• Study Completion: May 30, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (3); ES (5); DE (4); HU (4); US (36); IT (6); GB (2); UA (1); MO (1); SL (3); GE (6); PL (11); FR (3); BE (4)