Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-30 @ 2:53 AM
Study NCT ID:
NCT05848258
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2023-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Slovakia']}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 380}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2023-04-28', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50', 'timeFrame': 'Baseline to Week 12'}], 'secondaryOutcomes': [{'measure': 'Phase 2a: Percentage of Participants Achieving ACR20/50/70', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Phase 2b: Change from Baseline in DAS28-hsCRP', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Phase 2b: Percentage of Participants Achieving ACR20/70', 'timeFrame': 'Week 12'}, {'measure': 'Change from Baseline in Simplified Disease Activity Index (SDAI)', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change from Baseline in Clinical Disease Activity Index (CDAI)', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change from Baseline in ACR Core Set Values 68 Tender Joint Counts', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change from Baseline in ACR Core Set Values 66 Swollen Joint Counts', 'timeFrame': 'Baseline, Week 12'}, {'measure': "Change from Baseline in ACR Core Set Values Physician's Global Assessment of Disease Activity (PhGADA) Visual Analog Scale (VAS)", 'timeFrame': 'Baseline, Week 12'}, {'measure': "Change from Baseline in ACR Core Set Values Patient's Global Assessment of Disease Activity (PaGADA) VAS", 'timeFrame': 'Baseline, Week 12'}, {'measure': "Change from Baseline for Participant's Assessment of Arthritis Pain (VAS)", 'timeFrame': 'Baseline, Week 12'}, {'measure': "Change from Baseline for Participant's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI)", 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change from Baseline the Duration and Severity of Morning Joint Stiffness', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change from Baseline for Short Form-36 (SF-36) Physical Component Summary Score', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change from Baseline for SF-36 Mental Component Summary Score', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Pharmacokinetics (PK) Trough Plasma Concentrations of LY3871801', 'timeFrame': 'Baseline through Week 20'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lilly.com/en-US/trial/401857', 'label': 'An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis (RA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of adult-onset RA for at least 3 months prior to screening as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria.\n* Have moderately-to-severely active RA at screening and baseline, defined by the presence of\n\n * ≥6 swollen joints based on 66 joint count, and\n * ≥6 tender joints based on 68 joint count.\n* Have had a history of failure (an inadequate response, intolerance, or loss of response) to at least 1 conventional synthetic disease modifying anti rheumatic drug (csDMARD) and either 1 biologic (bDMARD), or targeted synthetic (tsDMARD) treatment.\n\nExclusion Criteria:\n\n* Have Class IV RA according to ACR revised criteria\n* Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to\n\n * poorly controlled diabetes or hypertension\n * chronic kidney disease stage IIIa or IIIb, IV, or V\n * symptomatic heart failure according to New York Heart Association class II, III, or IV\n * myocardial infarction,unstable angina pectoris, stroke, or transient ischemic attack within the past 12 months before randomization\n * severe chronic pulmonary disease, for example, requiring oxygen therapy\n * major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to\n\n * systemic lupus erythematosus\n * psoriatic arthritis\n * axial spondyloarthritis,including ankylosing spondylitis and non-radiographic axial spondyloarthritis\n * reactive arthritis\n * gout\n * scleroderma\n * polymyositis\n * dermatomyositis\n * active fibromyalgia, or\n * multiple sclerosis'}, 'identificationModule': {'nctId': 'NCT05848258', 'briefTitle': 'An Adaptive Phase 2a/2b Study of LY3871801 in Adult Participants With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'An Adaptive Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': '18516'}, 'secondaryIdInfos': [{'id': 'J3P-MC-FTAF', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2022-502994-40-00', 'type': 'OTHER', 'domain': 'EU Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3871801 Phase 2a', 'description': 'Participants will receive LY3871801 administered orally.', 'interventionNames': ['Drug: LY3871801']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Phase 2a', 'description': 'Participants will receive placebo.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY3871801 Dose 1 Phase 2b', 'description': 'Participants will receive LY3871801 administered orally.', 'interventionNames': ['Drug: LY3871801']}, {'type': 'EXPERIMENTAL', 'label': 'LY3871801 Dose 2 Phase 2b', 'description': 'Participants will receive LY3871801 administered orally.', 'interventionNames': ['Drug: LY3871801']}, {'type': 'EXPERIMENTAL', 'label': 'LY3871801 Dose 3 Phase 2b', 'description': 'Participants will receive LY3871801 administered orally.', 'interventionNames': ['Drug: LY3871801']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Phase 2b', 'description': 'Participants will receive placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY3871801', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3871801 Dose 1 Phase 2b', 'LY3871801 Dose 2 Phase 2b', 'LY3871801 Dose 3 Phase 2b', 'LY3871801 Phase 2a']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Placebo Phase 2a', 'Placebo Phase 2b']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92648', 'city': 'Huntington Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '714-378-2440'}, {'name': 'Christine Thai', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Newport Huntington Medical Group', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '33122', 'city': 'Doral', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Integrity Clinical Research', 'geoPoint': {'lat': 25.81954, 'lon': -80.35533}}, {'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Advanced Clinical Research of Orlando - Ocoee', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '561-774-8799'}, {'name': 'Jude Acloque', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Encore Medical Research - Weston', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '407-916-0060'}, {'name': 'Anand Patel', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Conquest Research', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '60527', 'city': 'Willowbrook', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '434-962-8466'}, {'name': 'Angela Crowley', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Willow Rheumatology and Wellness PLLC', 'geoPoint': {'lat': 41.76975, 'lon': -87.93589}}, {'zip': '70605', 'city': 'Lake Charles', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '337-312-8018'}, {'name': 'Enrique Mendez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Accurate Clinical Research, Inc', 'geoPoint': {'lat': 30.21309, 'lon': -93.2044}}, {'zip': '11201', 'city': 'Brooklyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '929-455-2500'}, {'name': 'David Goddard', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Joseph S. and Diane H. 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