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

NCT06041269
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
420
clinicaltrials.gov
Lead sponsor
AnaptysBio, Inc.
clinicaltrials.gov
Start date
2023-08-31
clinicaltrials.gov
Number of sites
92
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Summary
RENOIR Study: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe Rheumatoid Arthritis (RA)
clinicaltrials.gov
Short title
A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR)
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Official 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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-05-30
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First posted
2023-09-18
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Registry last updated
2024-11-25
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Primary completion date
2024-11-29
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Start date
2023-08-31
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Participants
420
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Participant count basis
Estimated
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Planned participants
420
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Protocol amendments
2
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Number of sites
92
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
AnaptysBio, Inc.
clinicaltrials.gov
Source registry
ClinicalTrials.gov
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Registry ID
NCT06041269
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06041269
clinicaltrials.gov
Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12

    Timeframe: 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

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

    Timeframe: Baseline to Week 12

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

    Timeframe: Baseline to Week 12

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No

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
Sources for eligibility
clinicaltrials.gov

  • AnaptysBio Investigative Site 10-132Flagstaff, United States
  • AnaptysBio Investigative Site 10-130Glendale, United States
  • AnaptysBio Investigative Site 10-129Phoenix, United States
  • AnaptysBio Investigative Site 10-131Tucson, United States
  • AnaptysBio Investigative Site 10-105Covina, United States
  • Anaptys Bio Investigative Site 10-119Rancho Mirage, United States
  • AnaptysBio Investigative Site 10-113San Diego, United States
  • AnaptysBio Investigative Site 10-127San Francisco, United States
  • AnaptysBio Investigative Site 10-136Temecula, United States
  • AnaptysBio Investigative Site 10-133Upland, United States
  • AnaptysBio Investigative Site 10-112Whitter, United States
  • AnaptysBio Investigative Site 10-103Aventura, United States
  • AnaptysBio Investigative Site 10-141Avon Park, United States
  • AnaptysBio Investigative Site 10-118Boynton Beach, United States
  • AnaptysBio Investigative Site 10-125Daytona Beach, United States
  • AnaptysBio Investigative Site 10-122Homestead, United States
  • Anaptys Bio Investigative Site 10-142Miami, United States
  • AnaptysBio Investigative Site 10-140Miami, United States
  • AnaptysBio Investigative Site 10-102Miami, United States
  • AnaptysBio Investigative Site 10-124Plantation, United States
  • AnaptysBio Investigative Site 10-139West Palm Beach, United States
  • AnaptysBio Investigative Site 10-114Chicago, United States
  • AnaptysBio Investigative Site 10-145Monroe, United States
  • AnaptysBio Investigative Site 10-143Brookline, United States
  • AnaptysBio Investigative Site 10-116Albuquerque, United States

And 67 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)