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Study of Efficacy and Safety of Rosnilimab in Subjects With Moderate to Severe Rheumatoid Arthritis (Renoir)

Sponsor
AnaptysBio, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06041269
Collaborator
(none)
420
Enrollment
32
Locations
4
Arms
25.3
Anticipated Duration (Months)
13.1
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Renoir Study: This study will evaluate the safety, tolerability, and efficacy of ANB 030 in subjects with moderate to severe Rheumatoid Arthritis (RA)

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This study is a Phase 2 global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab as an add on therapy in Subjects with Moderate to Severe Rheumatoid Arthritis.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
420 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 31, 2023
Anticipated Primary Completion Date :
Mar 8, 2025
Anticipated Study Completion Date :
Oct 8, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: ANB030 SC Dose 1

This arm will receive treatment SC

Drug: ANB030
PD-1 agonist antibody
Other Names:
  • Rosnilimab

    		•
    Experimental: ANB030 SC Dose 2

    This arm will receive treatment SC

    Drug: ANB030
    PD-1 agonist antibody
    Other Names:
  • Rosnilimab

    		•
    Experimental: ANB030 SC Dose 3

    This arm will receive treatment SC

    Drug: ANB030
    PD-1 agonist antibody
    Other Names:
  • Rosnilimab

    		•
    Placebo Comparator: Placebo

    This arm will receive Placebo

    Drug: Placebo
    Placebo

    Outcome Measures

    Primary Outcome Measures

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

    1. American College of Rheumatology 20%, Improvement Criteria (ACR20) response rate at Week 12 [Baseline to Week 12]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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 stage dosages for at least 8 weeks prior to joining and throughout the trial

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AnaptysBio Investigative Site 10-112 Whittier California United States 90602
    2 AnaptysBio Investigative Site 10-103 Aventura Florida United States 33180
    3 AnaptysBio Investigative Site 10-122 Homestead Florida United States 33032
    4 AnaptysBio Investigative Site 10-102 Miami Florida United States 33155
    5 AnaptysBio Investigative Site 10-124 Plantation Florida United States 33324
    6 AnaptysBio Investigative Site 10-101 Jackson Tennessee United States 38305
    7 AnaptysBio Investigative Site 10-108 Mesquite Texas United States 75150
    8 AnaptysBio Investigative Site 47-101 Mar del Plata Beunos Aires Argentina 7600
    9 AnaptysBio Investigative Site 47-104 Zárate Beunos Aires Argentina 2800
    10 AnaptysBio Investigative Site 47-102 Rosario Santa Fe Argentina 2000
    11 AnaptysBio Investigative Site 47-105 Rosario Santa Fe Argentina 2000
    12 AnaptysBio Investigative Site 47-103 San Miguel De Tucumán Tucuman Argentina 4000
    13 AnaptysBio Investigative Site 47-105 Cordoba Argentina 5016
    14 AnaptysBio Investigative Site 71-101 Tallinn Estonia 13419
    15 AnaptysBio Investigative Site 59-101 Tbilisi Georgia 0112
    16 AnaptysBio Investigative Site 59-105 Tbilisi Georgia 0131
    17 AnaptysBio Investigative Site 59-104 Tbilisi Georgia 0159
    18 AnaptysBio Investigative Site 59-106 Tbilisi Georgia 0159
    19 AnaptysBio Investigative Site 59-102 Tbilisi Georgia 0160
    20 AnaptysBio Investigative Site 59-103 Tbilisi Georgia 0172
    21 AnaptysBio Investigative Site 28-103 Debrecen Hajdu-Bihar Hungary 4032
    22 AnaptysBio Investigative Site 28-104 Budapest Hungary 1036
    23 AnaptysBio Investigative Site 51-102 San Miguel Ciudad De Mexico Mexico 11850
    24 AnaptysBio Investigative Site 51-106 Mexico City Mexico 11650
    25 AnaptysBio Investigative Site 73-101 Chisinau Kishinev Moldova, Republic of 29
    26 AnaptysBio Investigative Site 72-103 Cayma Arequipa Peru 4001
    27 AnaptysBio Investigative Site 72-103 Bella Vista Callao Peru Callao 2
    28 AnaptysBio Investigative Site 72-102 San Isidro Lima Peru Lima 27
    29 AnaptysBio Investigative Site 30-107 Warsaw Mazowieckie Poland 02-118
    30 AnaptysBio Investigative Site 30-112 Poznań Wielkopolskie Poland 60693
    31 AnaptysBio Investigative Site 30-102 Bytom Woj.Slaskie Poland 41-902
    32 AnaptysBio Investigative Site 67-101 Košice Slovakia 4011

    Sponsors and Collaborators

    • AnaptysBio, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AnaptysBio, Inc.
    ClinicalTrials.gov Identifier:
    NCT06041269
    Other Study ID Numbers:
    • ANB030-203
    First Posted:
    Sep 18, 2023
    Last Update Posted:
    Sep 18, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by AnaptysBio, Inc.
    PD-1 Agonist
    ANB030
    Renoir
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Sep 18, 2023