Viewing Study NCT06041269


Ignite Creation Date: 2025-12-24 @ 11:02 PM
Ignite Modification Date: 2025-12-30 @ 4:13 AM
Study NCT ID: NCT06041269
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-11-25
First Post: 2023-09-11
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR)
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Mexico', 'Peru']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2023-09-11', 'studyFirstSubmitQcDate': '2023-09-11', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from Baseline in 28-Joint Disease Activity Score based on CRP (DAS28-CRP) at Week 12', 'timeFrame': 'Baseline to Week 12', 'description': 'The DAS28-CRP is a validated composite assessment that assesses RA disease activity based on tender and swollen joint counts of 28 joints'}], 'secondaryOutcomes': [{'measure': 'American College of Rheumatology 20% Improvement Criteria (ACR20) response rate at Week 12', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'American College of Rheumatology 50% and 70% Improvement Criteria (ACR50 and ACR70) response rates at Week 12', 'timeFrame': 'Baseline to Week 12'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PD-1 Agonist', 'ANB030', 'RENOIR', 'Rosnilimab'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'RENOIR Study: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe Rheumatoid Arthritis (RA)', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Aged 18 years or older\n* A diagnosis of Rheumatoid Arthritis based on ACR/EULAR 2010 classification criteria, for at least 3 months before participating in the trial\n* 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\n* 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\n\nKey Exclusion Criteria:\n\n* History of an inflammatory joint disease other than Rheumatoid Arthritis\n* Prior exposure to a PD-1 or PD-L1 agonist, antagonist, or modulator\n* History of cancer within the last 5 years (except for some skin cancers)\n* Any known or suspected condition that would compromise immune status\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT06041269', 'briefTitle': 'A Study of Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Rheumatoid Arthritis (RENOIR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AnaptysBio, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ANB030-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosnilimab SC Dose 1', 'description': 'This arm will receive treatment SC', 'interventionNames': ['Drug: Rosnilimab']}, {'type': 'EXPERIMENTAL', 'label': 'Rosnilimab SC Dose 2', 'description': 'This arm will receive treatment SC', 'interventionNames': ['Drug: Rosnilimab']}, {'type': 'EXPERIMENTAL', 'label': 'Rosnilimab SC Dose 3', 'description': 'This arm will receive treatment SC', 'interventionNames': ['Drug: Rosnilimab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'This arm will receive Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rosnilimab', 'type': 'DRUG', 'otherNames': ['ANB030'], 'description': 'PD-1 agonist antibody', 'armGroupLabels': ['Rosnilimab SC Dose 1', 'Rosnilimab SC Dose 2', 'Rosnilimab SC Dose 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86001', 'city': 'Flagstaff', 'state': 'Arizona', 'country': 'United States', 'facility': 'AnaptysBio Investigative Site 10-132', 'geoPoint': {'lat': 35.19807, 'lon': -111.65127}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'AnaptysBio Investigative Site 10-130', 'geoPoint': {'lat': 33.53865, 'lon': 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'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AnaptysBio, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}