Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT07015905
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522181', 'term': 'apixaban'}, {'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-05-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death]', 'timeFrame': 'Through day 12 visit, approximately 14 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of confirmed symptomatic Deep Venous Thrombosis (DVT)', 'timeFrame': 'Through day 12 visit, approximately 14 days'}, {'measure': 'Incidence of confirmed Pulmonary Embolism (PE)', 'timeFrame': 'Through day 12 visit, approximately 14 days'}, {'measure': 'Incidence of VTE-related death', 'timeFrame': 'Through day 12 visit, approximately 14 days'}, {'measure': 'Incidence of the composite endpoint of major and clinically relevant non-major (CRNM) bleeding', 'timeFrame': 'Through day 12 visit, approximately 14 days'}, {'measure': 'Incidence of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death)', 'timeFrame': 'Through day 12 visit, approximately 14 days'}, {'measure': 'Incidence of minor bleeding', 'timeFrame': 'Through day 12 visit, approximately 14 days'}, {'measure': 'Incidence of Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Approximately day 90'}, {'measure': 'Incidence of Anti-Drug Antibodies (ADA) to REGN7508', 'timeFrame': 'Approximately day 90'}, {'measure': 'Titer of ADA to REGN7508', 'timeFrame': 'Approximately day 90'}, {'measure': 'Concentrations of REGN7508', 'timeFrame': 'Approximately day 90'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Unilateral Total Knee Arthroplasty (TKA)', 'Factor XI (FXI)'], 'conditions': ['Venous Thromboembolism (VTE)']}, 'descriptionModule': {'briefSummary': 'This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery.\n\nThe aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related diseases after total knee replacement surgery.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Is undergoing a primary elective unilateral TKA\n2. Is in good health based on laboratory safety testing as described in the protocol\n3. Body weight ≤130 kg at screening visit as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation\n2. History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol\n3. History of thromboembolic disease or thrombophilia\n4. History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization\n5. Has an estimated Glomerular Filtration Rate (GFR) of \\<30 mL/min/1.73 m2 at the screening visit as described in the protocol\n\nNote: Other protocol-defined Inclusion/ Exclusion Criteria apply'}, 'identificationModule': {'nctId': 'NCT07015905', 'acronym': 'ROXI-APEX', 'briefTitle': 'REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Open-Label, Sponsor-Blinded, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX)', 'orgStudyIdInfo': {'id': 'R7508-DVT-24116'}, 'secondaryIdInfos': [{'id': '2025-520478-20-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV REGN7508', 'interventionNames': ['Drug: REGN7508']}, {'type': 'EXPERIMENTAL', 'label': 'IV Placebo, SC REGN7508', 'interventionNames': ['Drug: REGN7508', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV Placebo, apixaban', 'interventionNames': ['Drug: Apixaban', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IV Placebo, enoxaparin', 'interventionNames': ['Drug: Enoxaparin', 'Drug: Placebo']}], 'interventions': [{'name': 'REGN7508', 'type': 'DRUG', 'description': 'Administered per the protocol', 'armGroupLabels': ['IV Placebo, SC REGN7508', 'IV REGN7508']}, {'name': 'Apixaban', 'type': 'DRUG', 'description': 'Administered per the protocol', 'armGroupLabels': ['IV Placebo, apixaban']}, {'name': 'Enoxaparin', 'type': 'DRUG', 'otherNames': ['Inhixa'], 'description': 'Administered per the protocol', 'armGroupLabels': ['IV Placebo, enoxaparin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered per the protocol', 'armGroupLabels': ['IV Placebo, SC REGN7508', 'IV Placebo, apixaban', 'IV Placebo, enoxaparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92504', 'city': 'Riverside', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'CARI Clinical Trials', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Denver Metro Orthopedics, P.C. Englewood Location', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '33445', 'city': 'Delray Beach', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Delray Physician Care Center', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '33175', 'city': 'Miami', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Bioresearch Partner', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sacred Heart Health System Inc', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Gulfcoast Research Institute', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33321', 'city': 'Tamarac', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Phoenix Clinical Research', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sinai Hospital of Baltimore, Inc.', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'HD Research - First Surgical Hospital', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '77058', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NextStage Clinical Research, All American Orthopedics and Sports Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Flourish Research - San Antonio (Formerly Clinical Trials of Texas)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '5804', 'city': 'Pleven', 'status': 'RECRUITING', 'country': 'Bulgaria', 'facility': 'Multi-profile Hospital for Active Treatment Hearth and Brain EAD', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '660-8511', 'city': 'Amagasaki-shi', 'state': 'Hyōgo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Kansai Rosai Hospital'}, {'zip': '901-0224', 'city': 'Tomigusuku', 'state': 'Okinawa', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Yuuai Medical Center', 'geoPoint': {'lat': 26.18583, 'lon': 127.68192}}, {'zip': '586-8521', 'city': 'Kawachi-Nagano', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'National Hospital Organization Osaka Minami Medical Center', 'geoPoint': {'lat': 34.44108, 'lon': 135.58283}}, {'zip': '530-0012', 'city': 'Kita-Ku', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Osaka Saiseikai Nakatsu Hospital'}, {'zip': '113-8431', 'city': 'Bunkyo-ku', 'state': 'Tokyo', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Juntendo University Hospital'}, {'zip': 'LV-3414', 'city': 'Liepāja', 'status': 'RECRUITING', 'country': 'Latvia', 'facility': 'Liepajas regionala slimnica; SIA', 'geoPoint': {'lat': 56.50474, 'lon': 21.01085}}, {'zip': 'LV-1004', 'city': 'Riga', 'status': 'RECRUITING', 'country': 'Latvia', 'facility': 'Rigas 2 slimnica, SIA', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV-1005', 'city': 'Riga', 'status': 'RECRUITING', 'country': 'Latvia', 'facility': 'Hospital of Traumatology and Orthopaedics', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV-1005', 'city': 'Riga', 'status': 'RECRUITING', 'country': 'Latvia', 'facility': 'ORTO Klinika', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV-4201', 'city': 'Valmiera', 'status': 'RECRUITING', 'country': 'Latvia', 'facility': 'Vidzemes slimnica', 'geoPoint': {'lat': 57.54108, 'lon': 25.42751}}, {'zip': 'LT-47144', 'city': 'Kaunas', 'status': 'RECRUITING', 'country': 'Lithuania', 'facility': 'Lietuvos sveikatos mokslu universiteto Kauno ligonine', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': 'LT-50161', 'city': 'Kaunas', 'status': 'RECRUITING', 'country': 'Lithuania', 'facility': 'Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}], 'centralContacts': [{'name': 'Clinical Trials Administrator', 'role': 'CONTACT', 'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643'}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.', 'ipdSharing': 'YES', 'description': 'When Regeneron has:\n\n* received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development\n* made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)\n* the legal authority to share the data, and\n* ensured the ability to protect participant privacy', 'accessCriteria': "Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}