Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-27 @ 7:11 AM
Study NCT ID:
NCT04864392
Status:
TERMINATED
Last Update Posted:
2025-07-24
First Post:
2021-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Lithuania']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic 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': 'ACTUAL', 'count': 582}}, 'statusModule': {'whyStopped': 'Study early terminated due to lack of effect (did not meet primary/key secondary endpoints). This decision was not linked to safety concerns', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'dispFirstSubmitDate': '2025-02-19', 'completionDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-23', 'studyFirstSubmitDate': '2021-02-26', 'studyFirstSubmitQcDate': '2021-04-27', 'dispFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the cartilage thickness of the medial compartment of the knee as assessed by imaging.', 'timeFrame': 'Week 0 to Week 104', 'description': 'To evaluate cartilage thickness changes'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index pain scale. The scale (5 questions) ranges from 0 to 50. Higher score indicates a worse outcome.', 'timeFrame': 'Week 0 to Week 104', 'description': 'To evaluate changes from baseline in OA pain'}, {'measure': 'Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index function scale. The scale (17 questions) ranges from 0 to 170. Higher scores indicates a worse outcome.', 'timeFrame': 'Week 0 to Week 104', 'description': 'To evaluate changes from baseline in physical function'}, {'measure': 'Change from baseline in the cartilage thickness of the knee as assessed by imaging.', 'timeFrame': 'Week 0 to Week 104', 'description': 'To evaluate changes from baseline the cartilage structure'}, {'measure': 'Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 40-meter (4×10m) fast-paced walk test', 'timeFrame': 'Week 0 to Week 104', 'description': 'To evaluate changes from baseline in physical function'}, {'measure': 'Change from baseline in the Osteoarthritis Research Society International physical performance-based assessments 30-second chair stand test', 'timeFrame': 'Week 0 to Week 104', 'description': 'To evaluate changes from baseline in physical function'}, {'measure': 'Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 6-minute walking test', 'timeFrame': 'Weeek 0 to Week 104', 'description': 'To evaluate changes from baseline in physical function'}, {'measure': 'Proportion of participants demonstrating structural progression', 'timeFrame': 'Week 0 to Week 104', 'description': 'To evaluate structural progression'}, {'measure': 'Assessing percentage of participants with adverse events and serious adverse events', 'timeFrame': 'Week 0 to Week 104', 'description': 'To evaluate safety and tolerability of the various LNA043 regimens'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LNA043', 'knee', 'arthritis', 'OA', 'knees'], 'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '36456835', 'type': 'DERIVED', 'citation': 'Gerwin N, Scotti C, Halleux C, Fornaro M, Elliott J, Zhang Y, Johnson K, Shi J, Walter S, Li Y, Jacobi C, Laplanche N, Belaud M, Paul J, Glowacki G, Peters T, Wharton KA Jr, Vostiar I, Polus F, Kramer I, Guth S, Seroutou A, Choudhury S, Laurent D, Gimbel J, Goldhahn J, Schieker M, Brachat S, Roubenoff R, Kneissel M. Angiopoietin-like 3-derivative LNA043 for cartilage regeneration in osteoarthritis: a randomized phase 1 trial. Nat Med. 2022 Dec;28(12):2633-2645. doi: 10.1038/s41591-022-02059-9. Epub 2022 Dec 1.'}]}, 'descriptionModule': {'briefSummary': 'The study will determine the optimal dosing regimen of LNA043 in patients with knee osteoarthritis (OA).', 'detailedDescription': 'This study is a 2-period, multicenter, randomized, parallel-group, double-blind, placebo-controlled study consisting of a 2-year Core period, followed by a 3 year extension period. The primary objective of this study is to assess the efficacy of LNA043 compared to placebo at Week 104 as measured by the mean change from baseline in cartilage thickness using qMRI of the target knee'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females between 40 and 75 years of age\n* Body mass index (BMI) \\< 40 kg/m2\n* Diagnosis of primary tibiofemoral knee OA by standard American College of Rheumatology clinical and radiographic criteria\n* and other criteria as specified by the protocol\n\nExclusion Criteria:\n\n* Participants with radiographic knee OA K-L grade = 4 on the non-target knee\n* Arthroscopy of the target knee within the 6 months prior to Screening\n* Hemoglobin \\< 8.5 g/dL (85 g/L) or platelet count \\< 100,000/μL\n* and other criteria as specified by the protocol'}, 'identificationModule': {'nctId': 'NCT04864392', 'acronym': 'ONWARDS', 'briefTitle': 'Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 5-year, Randomized, Double-blind, Placebo-controlled, Multi-center Study Assessing the Efficacy, Safety, and Tolerability of Intra-articular Regimens of LNA043 Versus Placebo in Patients With Symptomatic Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'CLNA043A12202'}, 'secondaryIdInfos': [{'id': '2020-004897-22', 'type': 'EUDRACT_NUMBER'}, {'id': '2023-509937-37-00', 'type': 'REGISTRY', 'domain': 'EU CT NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LNA043 Dosing Regimen A', 'description': 'LNA043 injection to the knee with dosing regimen A', 'interventionNames': ['Drug: LNA043 Dosing Regimen A']}, {'type': 'EXPERIMENTAL', 'label': 'LNA043 Dosing Regimen B', 'description': 'LNA04 injection to the knee with dosing regimen B', 'interventionNames': ['Drug: LNA043 Dosing Regimen B']}, {'type': 'EXPERIMENTAL', 'label': 'LNA043 Dosing Regimen C', 'description': 'LNA043 injection to the knee with dosing regimen C', 'interventionNames': ['Drug: LNA043 Dosing Regimen C']}, {'type': 'EXPERIMENTAL', 'label': 'LNA043 Dosing Regimen D', 'description': 'LNA043 injection to the knee with dosing regimen D', 'interventionNames': ['Drug: LNA043 Dosing Regimen D']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Injection to the knee', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LNA043 Dosing Regimen A', 'type': 'DRUG', 'otherNames': ['LNA043'], 'description': 'Injection to the knee', 'armGroupLabels': ['LNA043 Dosing Regimen A']}, {'name': 'LNA043 Dosing Regimen B', 'type': 'DRUG', 'otherNames': ['LNA043'], 'description': 'Injection to the knee', 'armGroupLabels': ['LNA043 Dosing Regimen B']}, {'name': 'LNA043 Dosing Regimen C', 'type': 'DRUG', 'otherNames': 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