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NCT07213778ClinicalTrials.gov

REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants

A Phase 3, Multicenter, Double-Blinded, Randomized Study to Evaluate REGN7508, a Factor XI Monoclonal Antibody, Versus Acetylsalicylic Acid for Prophylaxis of Symptomatic Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-ASPEN)

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called Acetylsalicylic Acid (ASA). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery. The aim…

Phase 32 000 participants recherchés36 sites4 pays

Catégories

Hématologie37%Musculosquelettique21%Cardiovasculaire21%Respiratoire21%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2025-10-09; recorded start 2025-11-24
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 251 other studies in this databaseCounted from the lead sponsor named in the record (Regeneron Pharmaceuticals)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm15/15

    Active-comparator control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type10/10

    Mortality / MACE endpoint (hard clinical outcome)

  • Multi-centre8/8

    Multi-centre: 32 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 2,000 participants (target), run at 36 sites, across 4 countries.

How this score is built
  • Enrolment33/40

    2,000 participants (target)

  • Site count18/25

    32 sites

  • Country count7/15

    4 countries

  • Planned duration6/10

    Planned over about 20 months

  • Sponsor scale9/10

    Regeneron Pharmaceuticals has led 248 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Résumé

This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called Acetylsalicylic Acid (ASA). 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 compared to acetylsalicylic acid. 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)

Affections

  • Symptomatic Venous Thromboembolism (VTE)

Éligibilité

SexeTous
Âges18 Years – Aucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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 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; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis (eg, hemophilia A or B, von Willebrand's Factor deficiency) 3. History of thromboembolic disease or thrombophilia 4. History of platelet dysfunction 5. Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuQUADRUPLE (4)
Recrutement2 000 participants recherchés

Promoteur et collaborateurs

  • Regeneron Pharmaceuticals Promoteur

Groupes et interventions

  • REGN7508 and PlaceboEXPERIMENTAL
  • Placebo and ASAACTIVE_COMPARATOR

Interventions

  • Médicament Acetylsalicylic Acid (ASA)

    Administered per the protocol

  • Médicament Placebo

    Administered per the protocol

  • Médicament REGN7508

    Administered per the protocol

Critères de jugement

  1. Critère de jugement principal

    Incidence of the composite endpoint of symptomatic VTE and all-cause death

    Délai Through day 30 visit

  2. Critère de jugement secondaire

    Incidence of all-cause death

    Délai Through day 30 visit

  3. Critère de jugement secondaire

    Time to first event of the confirmed symptomatic DVT

    Délai Through day 30 visit

  4. Critère de jugement secondaire

    Time to first event of the confirmed PE

    Délai Through day 30 visit

  5. Critère de jugement secondaire

    Time to the all-cause death

    Délai Through day 30 visit

  6. Critère de jugement secondaire

    Incidence of the composite endpoint of major bleeding and Clinically Relevant Non-Major (CRNM) bleeding

    Délai Through day 30 visit

  7. Critère de jugement secondaire

    Incidence of minor bleeding

    Délai Through day 30 visit

  8. Critère de jugement secondaire

    Incidence of Treatment-Emergent Adverse Events (TEAEs)

    Délai Through day 90 visit

  9. Critère de jugement secondaire

    Severity of TEAEs

    Délai Through day 90 visit

  10. Critère de jugement secondaire

    Incidence of Anti-drug Antibody (ADA) to REGN7508

    Délai Through day 90 visit

  11. Critère de jugement secondaire

    Magnitude of ADA to REGN7508

    Délai Through day 90 visit

  12. Critère de jugement secondaire

    Concentrations of REGN7508

    Délai Through day 90 visit

  13. Critère de jugement secondaire

    Time to first event of the composite endpoint of symptomatic VTE and all-cause death

    Délai Through day 30 visit

  14. Critère de jugement secondaire

    Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT)

    Délai Through day 30 visit

  15. Critère de jugement secondaire

    Incidence of confirmed Pulmonary Embolism (PE)

    Délai Through day 30 visit

Dates

Date de début24 novembre 2025 (réelle)
Achèvement principal17 mai 2027 (estimée)
Achèvement16 juillet 2027 (estimée)
Première publication9 octobre 2025 (réelle)
Dernière mise à jour14 septembre 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisseptembre 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

34 sites sont en recrutement

Greece

ÉtablissementVilleÉtat ou régionStatut
Henry Dunant Hospital CenterAthensAtticaEn recrutement

Malaysia

ÉtablissementVilleÉtat ou régionStatut
Hospital Pakar Universiti Sains MalaysiaKota BharuKelantanEn recrutement
Hospital Queen Elizabeth IIKota KinabaluSabahEn recrutement
Hospital Tengku Ampuan Afzan (HTTA)KuantanPahangEn recrutement
Sultan Abdul Halim HospitalSungai PetaniKedahEn recrutement

Moldova

ÉtablissementVilleÉtat ou régionStatut
PMSI Emergency Medicine InstituteChisinauEn recrutement

United States

ÉtablissementVilleÉtat ou régionStatut
Velocity Clinical Research, AnnapolisAnnapolisMarylandEn recrutement
Sinai Hospital of Baltimore, Inc.BaltimoreMarylandEn recrutement
Boston Medical CenterBostonMassachusettsEn recrutement
Tufts Medical CenterBostonMassachusettsEn recrutement
University of CincinnatiCincinnatiOhioEn recrutement
The Ohio State University Wexner Medical CenterColumbusOhioEn recrutement
Ohio Clinical TrialsColumbusOhioEn recrutement
South Florida Joint Replacement CenterDeerfield BeachFloridaEn recrutement
Duke University Health System (Duke Health), Duke University HospitalDurhamNorth CarolinaEn recrutement
HD Research - Memorial Hermann VillageHoustonTexasTerminé
NextStage Clinical Research, All American Orthopedics and Sports MedicineHoustonTexasEn recrutement
The Orthopaedic Research Foundation, Inc.IndianapolisIndianaEn recrutement
Horizon Clinical ResearchLa MesaCaliforniaEn recrutement
Sky Ridge Medical CenterLone TreeColoradoEn recrutement
Medical Research of Westchester - MPLUS Research NetworkMiamiFloridaEn recrutement
University of PittsburghPittsburghPennsylvaniaEn recrutement
Eximia Equihealth Research-Raleigh. LLCRaleighNorth CarolinaEn recrutement
The Vein and Vascular Center at Raleigh RadiologyRaleighNorth CarolinaEn recrutement
Eisenhower Medical CenterRancho MirageCaliforniaEn recrutement
Carilion ClinicRoanokeVirginiaEn recrutement
University of Rochester Medical CenterRochesterNew YorkEn recrutement
Endeavor Clinical TrialsSan AntonioTexasRetiré
Flourish Research - San Antonio (Formerly Clinical Trials of Texas)San AntonioTexasEn recrutement
Endeavor HealthSkokieIllinoisEn recrutement
Larkin Community Hospital South MiamiSouth MiamiFloridaEn recrutement
Spokane Joint Replacement CenterSpokaneWashingtonEn recrutement
Phoenix Clinical ResearchTamaracFloridaEn recrutement
Holy Name Medical CenterTeaneckNew JerseyEn recrutement
NextStage Clinical Research, St. Francis Medical ParkWichitaKansasEn recrutement
Coastal Vascular Institute, PAWilmingtonNorth CarolinaEn recrutement

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 14 septembre 2026

    Site ajouté

    2 sites added (36 total)

    3436

  2. 19 août 2026

    Site ajouté

    2 sites added (34 total)

    3234

Registre: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07213778