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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
420

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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