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

November 21, 2024 updated by: AnaptysBio, Inc.

A Phase 2, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

420

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2170
        • AnaptysBio Investigative Site 13-103
      • Liège, Belgium, 4000
        • AnaptysBio Investigative Site 13- 105
    • Bruxelles
      • Anderlecht, Bruxelles, Belgium, 1070
        • AnaptysBio Investigative Site 13-102
    • Vlaams-Braba
      • Leuven, Vlaams-Braba, Belgium, 3000
        • AnaptysBio Investigative Site 13-104
  • Canada
    • Ontario
      • Niagara Falls, Ontario, Canada, L2E6A6
        • AnaptysBio Investigative Site 11-104
      • Windsor, Ontario, Canada, N8X1T3
        • AnaptysBio Investigative Site 11-101
    • Quebec
      • Trois-Rivières, Quebec, Canada, G9A 3Y2
        • AnaptysBio Investigative Site 11-103
  • Estonia
      • Tallinn, Estonia, 10117
        • AnaptysBio Investigative Site 71-102
      • Tallinn, Estonia, 13419
        • AnaptysBio Investigative Site 71-101
    • Tartumaa
      • Tartu, Tartumaa, Estonia, 50106
        • AnaptysBio Investigative Site 71-103
  • France
      • Cahors, France, 46000
        • AnaptysBio Investigative Site 16-105
      • Montpellier, France, 34090
        • AnaptysBio Investigative Site 16-101
      • Toulouse cedex 9, France, 31059
        • AnaptysBio Investigative Site 16-102
  • Georgia
      • Tbilisi, Georgia, 0160
        • AnaptysBio Investigative Site 59-102
      • Tbilisi, Georgia, 0112
        • AnaptysBio Investigative Site 59-101
      • Tbilisi, Georgia, 0131
        • AnaptysBio Investigative Site 59-105
      • Tbilisi, Georgia, 0159
        • AnaptysBio Investigative Site 59-104
      • Tbilisi, Georgia, 0159
        • AnaptysBio Investigative Site 59-106
      • Tbilisi, Georgia, 0172
        • AnaptysBio Investigative Site 59-103
  • Germany
      • Berlin, Germany, 12161
        • AnaptysBio Investigative Site 17-103
      • Hamburg, Germany, 20095
        • AnaptysBio Investigative Site 17-102
      • Hanover, Germany, 30159
        • AnaptysBio Investigative Site 17-107
      • Herne, Germany, 44649
        • AnaptysBio Investigative Site 17-105
  • Hungary
      • Budapest, Hungary, 1036
        • Anaptys Bio Investigative Site 28-106
      • Budapest, Hungary, 1036
        • AnaptysBio Investigative Site 28-104
    • Hajdu-Bihar
      • Debrecen, Hajdu-Bihar, Hungary, 4032
        • AnaptysBio Investigative Site 28-103
    • Pest
      • Budapest, Pest, Hungary, 1023
        • AnaptysBio Investigative Site 28-101
  • Italy
      • Bari, Italy, 70124
        • AnaptysBio Investigative Site 20-104
      • Milan, Italy, 20122
        • AnaptysBio Investigative Site 20-110
      • Novara, Italy, 28100
        • AnaptysBio Investigative Site 20-105
      • Roma, Italy, 128
        • AnaptysBio Investigative Site 20-108
    • Lombardy
      • Milan, Lombardy, Italy, 20162
        • AnaptysBio Investigative Site 20-106
    • PV
      • Pavia, PV, Italy, 27100
        • AnaptysBio Investigative Site 20-101
  • Moldova, Republic of
    • Kishinev
      • Chisinau, Kishinev, Moldova, Republic of, MD-2025
        • AnaptysBio Investigative Site73-101
  • Poland
      • Białystok, Poland, 15-707
        • AnaptysBio Investigative Site 30-111
      • Bydgoszcz, Poland, 85-065
        • AnaptysBio Investigative Site 30-109
      • Warsaw, Poland, 00-874
        • AnaptysBio Investigative Site 30-108
    • Kuj-pom
      • Toruń, Kuj-pom, Poland, 87-100
        • AnaptysBio Investigative Site 30-104
    • Lubuskie
      • Nowa Sól, Lubuskie, Poland, 67-100
        • AnaptysBio Investigative Site 30-103
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 02-118
        • AnaptysBio Investigative Site 30-107
    • Opolskie
      • Opole, Opolskie, Poland, 45-819
        • AnaptysBio Investigative Site 30-106
    • Wielkopolskie
      • Poznań, Wielkopolskie, Poland, 60693
        • AnaptysBio Investigative Site 30-112
      • Poznań, Wielkopolskie, Poland, 61-113
        • AnaptysBio Investigative Site 30-105
      • Poznań, Wielkopolskie, Poland, 61-293
        • AnaptysBio Investigative Site 30-101
    • Woj.Slaskie
      • Bytom, Woj.Slaskie, Poland, 41-902
        • AnaptysBio Investigative Site 30-102
  • Slovakia
      • Košice, Slovakia, 4011
        • AnaptysBio Investigative Site 67-101
      • Martin, Slovakia, 03601
        • AnaptysBio Investigative Site 67-102
      • Piešťany, Slovakia, 92101
        • AnaptysBio Investigative Site 67-103
  • Spain
      • Córdoba, Spain, 14004
        • AnaptysBio Investigative Site 24-105
      • Santiago De Compostela, Spain, 15702
        • AnaptysBio Investigative Site 24-104
      • Santiago De Compostela, Spain, 15706
        • AnaptysBio Investigative Site 24-103
    • Bizkaia
      • Bilbao, Bizkaia, Spain, 48013
        • AnaptysBio Investigative Site 24-101
    • Coruna
      • Santiago de Compostela, Coruna, Spain, 15895
        • AnaptysBio Investigative Site 24-102
  • Ukraine
      • Kyiv, Ukraine, 01135
        • AnaptysBio Investigative Site 34-101
  • United Kingdom
      • London, United Kingdom, IG14HP
        • AnaptysBio Investigative Site 27-101
      • Manchester, United Kingdom, M278FF
        • AnaptysBio Investigative Site 27-102
  • United States
    • Arizona
      • Flagstaff, Arizona, United States, 86001
        • AnaptysBio Investigative Site 10-132
      • Glendale, Arizona, United States, 85306
        • AnaptysBio Investigative Site 10-130
      • Phoenix, Arizona, United States, 85037
        • AnaptysBio Investigative Site 10-129
      • Tucson, Arizona, United States, 85704
        • AnaptysBio Investigative Site 10-131
    • California
      • Covina, California, United States, 91722
        • AnaptysBio Investigative Site 10-105
      • Rancho Mirage, California, United States, 92270
        • Anaptys Bio Investigative Site 10-119
      • San Diego, California, United States, 92108
        • AnaptysBio Investigative Site 10-113
      • San Francisco, California, United States, 94123
        • AnaptysBio Investigative Site 10-127
      • Temecula, California, United States, 92592
        • AnaptysBio Investigative Site 10-136
      • Upland, California, United States, 91786
        • AnaptysBio Investigative Site 10-133
      • Whitter, California, United States, 90602
        • AnaptysBio Investigative Site 10-112
    • Florida
      • Aventura, Florida, United States, 33180
        • AnaptysBio Investigative Site 10-103
      • Avon Park, Florida, United States, 33825
        • AnaptysBio Investigative Site 10-141
      • Boynton Beach, Florida, United States, 33436
        • AnaptysBio Investigative Site 10-118
      • Daytona Beach, Florida, United States, 32117
        • AnaptysBio Investigative Site 10-125
      • Homestead, Florida, United States, 33032
        • AnaptysBio Investigative Site 10-122
      • Miami, Florida, United States, 33125
        • Anaptys Bio Investigative Site 10-142
      • Miami, Florida, United States, 33126
        • AnaptysBio Investigative Site 10-140
      • Miami, Florida, United States, 33155
        • AnaptysBio Investigative Site 10-102
      • Plantation, Florida, United States, 33324
        • AnaptysBio Investigative Site 10-124
      • West Palm Beach, Florida, United States, 33407
        • AnaptysBio Investigative Site 10-139
    • Illinois
      • Chicago, Illinois, United States, 60640
        • AnaptysBio Investigative Site 10-114
    • Louisiana
      • Monroe, Louisiana, United States, 71203
        • AnaptysBio Investigative Site 10-145
    • Massachusetts
      • Brookline, Massachusetts, United States, 02445
        • AnaptysBio Investigative Site 10-143
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • AnaptysBio Investigative Site 10-116
    • North Carolina
      • Smithfield, North Carolina, United States, 27577
        • AnaptysBio Investigative Site 10-148
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • AnaptysBio Investigative Site 10-146
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • AnaptysBio Investigative Site 10-101
    • Texas
      • Allen, Texas, United States, 75013
        • AnaptysBio Investigative Site 10-120
      • Colleyville, Texas, United States, 76034
        • AnaptysBio Investigative Site 10-107
      • Katy, Texas, United States, 77450
        • AnaptysBio Investigative Site 10-123
      • Mesquite, Texas, United States, 75150
        • AnaptysBio Investigative Site 10-108
      • Plano, Texas, United States, 75024
        • AnaptysBio Investigative Site 10-110
      • The Woodlands, Texas, United States, 77382
        • AnaptysBio Investigative Site 10-106
      • Tomball, Texas, United States, 77375
        • AnaptysBio Investigative Site 10-121
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • AnaptysBio Investigative Site 10-117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
This arm will receive Placebo
Drug: Placebo
Placebo
Experimental: Rosnilimab SC Dose 1
This arm will receive treatment SC
Drug: Rosnilimab
PD-1 agonist antibody
Other Names:
  • ANB030
Experimental: Rosnilimab SC Dose 2
This arm will receive treatment SC
Drug: Rosnilimab
PD-1 agonist antibody
Other Names:
  • ANB030
Experimental: Rosnilimab SC Dose 3
This arm will receive treatment SC
Drug: Rosnilimab
PD-1 agonist antibody
Other Names:
  • ANB030

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12
Time Frame: 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
Baseline to Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AnaptysBio, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2023

Primary Completion (Estimated)

November 29, 2024

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 18, 2023

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANB030-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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