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REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults

Study acronym: ROXI-APEX
StatusRecruiting
PhasePhase 3
Started2025-06-25
View on ClinicalTrials.gov ↗

Amendment history

2026-07-10
Study Status, Contacts/Locations v17
Study sites45→46
2026-06-15
Study Status, Arms and Interventions, Contacts/Locations v16
Study sites44→45
2026-05-04
Study Status, Contacts/Locations v15
Trial sites expanded: 41 → 44 locations
2026-04-07
Study Status, Contacts/Locations v14
Study sites40→41
2026-03-05
Study Identification, Study Status, Study Description, Outcome Measures, Contacts/Locations v13
Study sites35→40
Secondary endpoints10 to 14 entries
Time-to-first event of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death) Time-to-first event of confirmed symptomatic DVT Time-to-first event of confirmed PE Time to VTE-related death Incidence of the composite endpoint of major and clinicallyClinically relevantRelevant nonNon-majorMajor (CRNM) bleeding IncidenceOccurrence of Anti-Drug Antibodies (ADA) to REGN7508 TiterMagnitude of ADA to REGN7508
Show 12 earlier versions
2026-02-19
Study Status, Contacts/Locations v12
Study sites33→35
2026-02-02
Study Status, Contacts/Locations v11
Study sites31→33
2026-01-20
Study Status, Contacts/Locations v10
Study sites25→31
2026-01-06
Study Status, Contacts/Locations v9
Study sites24→25
2025-12-16
Study Status, Contacts/Locations v8
Study sites21→24
2025-12-03
Study Status, Contacts/Locations v7
Study sites13→21
2025-11-20
Study Status, Contacts/Locations v6
Study sites9→13
2025-11-06
Study Status, Contacts/Locations v5
Study sites7→9
2025-10-06
Study Status, Contacts/Locations v4
Study sites4→7
2025-09-05
Study Status, Contacts/Locations v3
Study sites3→4
2025-08-28
Study Status, Contacts/Locations v2
Study sites1→3
2025-07-15
Not Yet Recruiting→Recruiting Study Identification, Study Status, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-06-30→confirmed 2025-06-25
Study sites0→1
Eligibility criteriarevised
[...] ory safety testing as described in the protocol Body weight <≤130 kg at screening visit as described in the protocol Key E [...]
Secondary endpoints10 entries, revised
Incidence of the composite endpoint of major and clinically relevant nonmajornon-major (CRNM) bleeding
2025-06-03
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
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. The 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. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
Trial Details
NCT Number NCT07015905
Lead Sponsor Regeneron Pharmaceuticals
Conditions Venous Thromboembolism (VTE)
Enrollment 2,000 participants
Start Date 2025-06-25
Primary Completion 2027-02-20 (estimated)
Study Completion 2027-05-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-28