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Recruiting NCT07015905

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

Phase III Interventional Venous Thromboembolism (VTE)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: REGN7508, Apixaban, Enoxaparin, Placebo.
Who it may be relevant to
Registry conditions: Venous Thromboembolism (VTE). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Bulgaria, Hungary, Japan, Latvia +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Multicenter, Randomized, Open-Label, 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)

Overview

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)

Interventions

  • Drug REGN7508
    Administered per the protocol
  • Drug Apixaban
    Administered per the protocol
  • Drug Enoxaparin
    Administered per the protocol
  • Drug Placebo
    Administered per the protocol

Primary outcome measures

  • Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death] [Time frame: Through day 12 visit, approximately 14 days]
Secondary outcome measures (12)
  • Time-to-first event of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death) [Time frame: Through day 12 visit, approximately 14 days]
  • Incidence of confirmed symptomatic Deep Venous Thrombosis (DVT) [Time frame: Through day 12 visit, approximately 14 days]
  • Incidence of confirmed Pulmonary Embolism (PE) [Time frame: Through day 12 visit, approximately 14 days]
  • Incidence of VTE-related death [Time frame: Through day 12 visit, approximately 14 days]
  • Time-to-first event of confirmed symptomatic DVT [Time frame: Through day 12 visit, approximately 14 days]
  • Time-to-first event of confirmed PE [Time frame: Through day 12 visit, approximately 14 days]
  • Time to VTE-related death [Time frame: Through day 12 visit, approximately 14 days]
  • Incidence of the composite endpoint of major and Clinically Relevant Non-Major (CRNM) bleeding [Time frame: Through day 12 visit, approximately 14 days]
  • Incidence of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death) [Time frame: Through day 12 visit, approximately 14 days]
  • Incidence of minor bleeding [Time frame: Through day 12 visit, approximately 14 days]
  • Incidence of Treatment Emergent Adverse Events (TEAEs) [Time frame: Approximately day 90]
  • Occurrence of Anti-Drug Antibodies (ADA) to REGN7508 [Time frame: Approximately day 90]

Eligibility criteria

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

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

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 20 centers
  • Shoals Medical Trials, Inc. — Sheffield
  • CARI Clinical Trials — Riverside
  • Denver Metro Orthopedics, P.C. Englewood Location — Englewood
  • Delray Physician Care Center — Delray Beach
  • Bioresearch Partner — Miami
  • Sacred Heart Health System Inc — Pensacola
  • Gulfcoast Research Institute — Sarasota
  • Phoenix Clinical Research — Tamarac
  • … and 12 more centers
Japan · 6 centers
  • Kansai Rosai Hospital — Amagasaki-shi
  • Yuuai Medical Center — Tomigusuku
  • National Hospital Organization Osaka Minami Medical Center — Kawachi-Nagano
  • Osaka Saiseikai Nakatsu Hospital — Kita-Ku
  • Juntendo University Hospital — Bunkyo-ku
  • Saga University Hospital — Saga
Latvia · 5 centers
  • Liepajas regionala slimnica; SIA — Liepāja
  • Rigas 2 slimnica, SIA — Riga
  • Hospital of Traumatology and Orthopaedics — Riga
  • ORTO Klinika — Riga
  • Vidzemes slimnica — Valmiera
Hungary · 4 centers
  • Szegedi Tudomanyegyetem; Albert Szent-Gyorgyi Clinical Center — Szeged
  • Gyor-Moson-Sopron Varmegyei Egyetemi Oktato Korhaz — Győr
  • University of Debrecen — Debrecen
  • Semmelweis University — Budapest
Bulgaria · 3 centers
  • Multi-profile Hospital for Active Treatment Hearth and Brain EAD — Pleven
  • Multiprofile Hospital for Active Treatment; Sveta Sofia EOOD (MBAL Sveta Sofia), — Sofia
  • University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich" — Stara Zagora
Lithuania · 3 centers
  • Lietuvos sveikatos mokslu universiteto Kauno ligonine — Kaunas
  • Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik — Kaunas
  • Vsi Klaipedos Universitetine Ligonine — Klaipėda
Poland · 3 centers
  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. z o.o. — Krakow
  • Uniwersytecki Szpital Kliniczny nr.2 Uniwersytetu Medycznego w Lodzi — Lodz
  • Samodzieny Publiczny Zaklad Opieki Zdorowotne (SP ZOZ) Centralny Szpital Kliniczny Uniwers — Lodz
Romania · 2 centers
  • Arensia Clinics S.R.L — Bucharest
  • ARENSIA Exploratory Medicine, County Hospital Cluj-Napoca — Cluj-Napoca

Identifiers

NCT: NCT07015905 · R7508-DVT-24116 · 2025-520478-20-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗