2025-520478-20-00
Not yet recruiting
Phase 3
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).
Regeneron Pharmaceuticals Inc.15 sites in 5 countries1,067 target enrollmentStarted: October 8, 2025Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Enrollment
- 1,067
- Locations
- 15
- Primary Endpoint
- Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death].
Overview
Brief Summary
To evaluate the efficacy of IV REGN7508 for the prevention of VTE after TKA compared to enoxaparin and apixaban.
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Is undergoing a primary elective unilateral TKA .
- •Is in good health based on laboratory safety testing as described in the protocol.
- •Body weight <130 kg at screening visit as described in the protocol.
- •Other protocol-defined Inclusion Criteria apply.
Exclusion Criteria
- •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.
- •History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol.
- •History of thromboembolic disease or thrombophilia.
- •History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization.
- •Has an estimated Glomerular Filtration Rate (GFR) of <30 mL/min/1.73 m2 at the screening visit as described in the protocol.
- •Other protocol-defined Exclusion Criteria apply.
Outcomes
Primary Outcomes
Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death].
Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death].
Secondary Outcomes
- Concentrations of REGN7508.
- Incidence of confirmed symptomatic Deep Venous Thrombosis (DVT).
- Incidence of confirmed Pulmonary Embolism (PE).
- Incidence of VTE-related death.
- Incidence of the composite endpoint of major and clinically relevant nonmajor (CRNM) bleeding.
- Incidence of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death).
- Incidence of minor bleeding.
- Incidence of Treatment Emergent Adverse Events (TEAEs).
- Incidence of Anti-Drug Antibodies (ADA) to REGN7508.
- Titer of ADA to REGN7508.
Investigators
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.
Study Sites (15)
Loading locations...
Similar Trials
Not yet recruiting
Phase 2
Randomized, controlled, multi-center clinical trial for the treatment of osteoarthritis behind the kneecap with tissue engineered nasal cartilage implantation vs current standard of care (ENCANTO)2024-513683-25-00Universitaetsspital Basel122
Not yet recruiting
Phase 2
Monocentric Pilot Trial evaluating the safety and efficacy of Regorafenib in Arterio-Venous Malformations that are refractory to standard care2022-501830-47-01Cliniques Universitaires Saint-Luc10
Completed
Not Applicable
This is a study to evaluate dose-flexibility of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis2023-504869-23-00AbbVie Deutschland GmbH & Co. KG272
Recruiting
Phase 1/2
ELVN-002 combined with trastuzumab +/- chemotherapy in HER2 + Solid Tumors2023-509716-29-00Enliven Therapeutics Inc.156
Not yet recruiting
Phase 3
Vorasidenib for the treatment of IDH-mutant astrocytoma after standard chemoradiotherapy2024-519404-27-00Europese Organisatie Voor Onderzoek En Behandeling Van Kanker Organisation Europeenne Pour La Recherche Et Le Traitement Du Cancer European Organi247