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NCT Number: NCT06041269

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

AnaptysBio Investigative Site 13-102, Anderlecht, Brussels Capital, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosnilimab

Drug

PD-1 agonist antibody

Other names: ANB030

Placebo

Drug

Placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. American College of Rheumatology 20% Improvement Criteria (ACR20) response rate at Week 12

    Time frame: Baseline to Week 12

  2. American College of Rheumatology 50% and 70% Improvement Criteria (ACR50 and ACR70) response rates at Week 12

    Time frame: Baseline to Week 12

Sponsors and collaborators

Lead sponsor

AnaptysBio, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 18, 2023
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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