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

Purpose

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)

Condition

  • Venous Thromboembolism (VTE)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
IV REGN7508
  • Drug: REGN7508
    Administered per the protocol
Experimental
IV Placebo, SC REGN7508
  • Drug: REGN7508
    Administered per the protocol
  • Drug: Placebo
    Administered per the protocol
Active Comparator
IV Placebo, apixaban
  • Drug: Apixaban
    Administered per the protocol
  • Drug: Placebo
    Administered per the protocol
Active Comparator
IV Placebo, enoxaparin
  • Drug: Enoxaparin
    Administered per the protocol
    Other names:
    • Inhixa
  • Drug: Placebo
    Administered per the protocol

Recruiting Locations

Shoals Medical Trials, Inc.
Sheffield, Alabama 35660

CARI Clinical Trials
Riverside, California 92504

Denver Metro Orthopedics, P.C. Englewood Location
Englewood, Colorado 80113

Delray Physician Care Center
Delray Beach, Florida 33445

Bioresearch Partner
Miami, Florida 33175

Sacred Heart Health System Inc
Pensacola, Florida 32504

Gulfcoast Research Institute
Sarasota, Florida 34232

Phoenix Clinical Research
Tamarac, Florida 33321

Sinai Hospital of Baltimore, Inc.
Baltimore, Maryland 21215

Brigham and Women's Hospital
Boston, Massachusetts 02115

Curalta Clinical Trials
Westwood, New Jersey 07675

Keystone Clinical Studies LLC, dba Flourish Research
Plymouth Meeting, Pennsylvania 19462

HD Research - First Surgical Hospital
Bellaire, Texas 77401

University of Texas (UT); Southwestern Medical Center
Dallas, Texas 75390

NextStage Clinical Research, All American Orthopedics and Sports Medicine
Houston, Texas 77058

Futuro Clinical Trials
McAllen, Texas 78501

Flourish Research - San Antonio (Formerly Clinical Trials of Texas)
San Antonio, Texas 78229

DRx Clinical Research, LLC
St. George, Utah 84770

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com