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Clinical Trials/2022-501470-18-00
2022-501470-18-00
Completed
Phase 2

A Phase 2, Multicenter, Randomized, Open-Label, Active-Control Study of REGN9933, a Factor XI Monoclonal Antibody, for Prevention of Venous Thromboembolism after Elective, Unilateral, Total Knee Arthroplasty

Regeneron Pharmaceuticals Inc.16 sites in 6 countries408 target enrollmentStarted: April 6, 2023Last updated:
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Overview

Phase
Phase 2
Status
Completed
Sponsor
Regeneron Pharmaceuticals Inc.
Enrollment
408
Locations
16
Primary Endpoint
The primary endpoint is the incidence of confirmed, adjudicated venous thromboembolism (VTE) through day 12 (REGN9933 vs enoxaparin).
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The primary objective of the study is to evaluate the efficacy of REGN9933 for the prevention of venous thromboembolism (VTE) after unilateral total knee arthroplasty (TKA), compared to enoxaparin.

Study Design

Allocation
Randomized
Primary Purpose
Method of treatment assignment
Masking
None

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Undergoing elective unilateral TKA
  • •Has a body weight ≤130 kg at screening visit
  • •Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and Electrocardiograms (ECG) performed at screening and/or prior to administration of initial dose of study drug
  • •Is in good health based on laboratory safety testing obtained during the screening period as described in the protocol
  • •Other protocol-defined inclusion criteria apply

Exclusion Criteria

  • •History of bleeding in the past 6 months 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.
  • •History of thromboembolic disease or thrombophilia.
  • •History of major surgery, including brain, spinal, or ocular, within approximately the past 6 months.
  • •History of major trauma within approximately the past 6 months.
  • •Hospitalized (>24 hours) for any reason within 30 days of the screening visit.
  • •Using the Modification of Diet in Renal Disease equation, has an estimated glomerular filtration rate as described in the protocol.
  • •Other protocol-defined exclusion criteria apply.

Outcomes

Primary Outcomes

The primary endpoint is the incidence of confirmed, adjudicated venous thromboembolism (VTE) through day 12 (REGN9933 vs enoxaparin).

The primary endpoint is the incidence of confirmed, adjudicated venous thromboembolism (VTE) through day 12 (REGN9933 vs enoxaparin).

Secondary Outcomes

  • Incidence of major bleeding (up to approximately day 12).
  • Incidence of clinically relevant non-major (CRNM) bleeding (up to approximately day 12).
  • Incidence of treatment emergent adverse events (TEAEs) (through end of study; approximately day 75).
  • Incidence of major VTE through day 12 (REGN9933 versus enoxaparin).
  • Incidence of DVT as measured by venography of the operated leg (approximately day 12; REGN9933 vs enoxaparin).
  • Concentrations of REGN9933 in serum (through end of study; approximately day 75).
  • Change in activated partial thromboplastin time (aPTT) from baseline (through end of study; approximately day 75).
  • Change in prothrombin time (PT) from baseline (through end of study; approximately day 75).
  • Incidence of anti-drug antibodies (ADA) to REGN9933 (through end of study; approximately day 75).
  • Titer of anti-drug antibodies (ADA) to REGN9933 (through end of study; approximately day 75).
  • Incidence of confirmed, adjudicated VTE (baseline through day 12; enoxaparin vs apixaban).

Investigators

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

Medical Affairs

Scientific

Regeneron Pharmaceuticals Inc.

Study Sites (16)

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