Clinical trial NCT07015905: REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Venous Thromboembolism (VTE)
Keywords: Unilateral Total Knee Arthroplasty (TKA)
Factor XI (FXI)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-06-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: Key Inclusion Criteria:

1. Is undergoing a primary elective unilateral TKA
2. Is in good health based on laboratory safety testing as described in the protocol
3. Body weight \<130 kg at screening visit as described in the protocol

Key Exclusion Criteria:

1. 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
2. History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol
3. History of thromboembolic disease or thrombophilia
4. History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization
5. Has an estimated Glomerular Filtration Rate (GFR) of \<30 mL/min/1.73 m2 at the screening visit as described in the protocol

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Primary outcomes:
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
Secondary outcomes:
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 nonmajor (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
Other outcomes:
Locations:
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: