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Clinical Trials/2025-520479-25-00
2025-520479-25-00
Recruiting
Phase 3

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)

Regeneron Pharmaceuticals Inc.5 sites in 2 countries58 target enrollmentStarted: December 5, 2025Last updated:
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ConditionsSymptomatic Venous Thromboembolism (VTE)
InterventionsREGN7508Placebo for REGN7508ACETYLSALICYLIC ACIDPlacebo for Acetylsalicylic Acid
DrugsREGN7508Placebo for REGN7508ACETYLSALICYLIC ACIDPlacebo for Acetylsalicylic Acid

Overview

Phase
Phase 3
Status
Recruiting
Sponsor
Regeneron Pharmaceuticals Inc.
Enrollment
58
Locations
5
Primary Endpoint
Incidence of the composite endpoint of symptomatic VTE and VTE-related death
OverviewEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To evaluate the efficacy of IV REGN7508 for the prevention of symptomatic VTE after TKA compared to ASA

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
  • •Other protocol-defined Inclusion criteria apply

Exclusion Criteria

  • •Has 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.
  • •Has a 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).
  • •Has a history of thromboembolic disease or thrombophilia.
  • •Has a history of platelet dysfunction.
  • •Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery
  • •Other protocol-defined Exclusion criteria apply

Arms & Interventions

REGN7508

Test

Intervention: REGN7508 (Drug)

Placebo for REGN7508

Placebo

Intervention: Placebo for REGN7508 (Drug)

ACETYLSALICYLIC ACID

Comparator

Intervention: ACETYLSALICYLIC ACID (Drug)

Placebo for Acetylsalicylic Acid

Placebo

Intervention: Placebo for Acetylsalicylic Acid (Drug)

Outcomes

Primary Outcomes

Incidence of the composite endpoint of symptomatic VTE and VTE-related death

Incidence of the composite endpoint of symptomatic VTE and VTE-related death

Secondary Outcomes

  • Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT)
  • Incidence of confirmed Pulmonary Embolism (PE)
  • Incidence of VTE-related death
  • Time to first event of the composite endpoint of symptomatic VTE and 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 bleeding and Clinically Relevant Non-Major (CRNM) bleeding
  • Incidence of minor bleeding
  • Incidence of Treatment-Emergent Adverse Events (TEAEs)
  • Severity of TEAEs
  • Incidence of Anti-drug Antibody (ADA) to REGN7508
  • Magnitude of ADA to REGN7508
  • Concentrations of REGN7508

Investigators

Sponsor
Regeneron Pharmaceuticals Inc.
Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Medical Affairs

Scientific

Regeneron Pharmaceuticals Inc.

Study Sites (5)

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