Recruiting
Phase 3

REGN7508

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07015905

Conditions

Venous Thromboembolism (VTE)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

REGN7508

Apixaban

Enoxaparin

Placebo

Study Details

Brief summary:

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)

Conditions

Venous Thromboembolism (VTE)

Study ID

NCT07015905

Start date

Jun 25, 2025

Status verified date

Jul, 2026

Completion date

May 12, 2027

Anticipated

Primary completion date

Feb 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
3. Body weight ≤130 kg at screening visit 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 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

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IV REGN7508

experimental: IV Placebo, SC REGN7508

active comparator: IV Placebo, apixaban

active comparator: IV Placebo, enoxaparin

Interventions

REGN7508

Administered per the protocol

Apixaban

Administered per the protocol

Enoxaparin

Administered per the protocol

Placebo

Administered per the protocol

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Shoals Medical Trials, Inc.

Recruiting

Sheffield, Alabama, United States, 35660

CARI Clinical Trials

Recruiting

Riverside, California, United States, 92504

Denver Metro Orthopedics, P.C. Englewood Location

Recruiting

Englewood, Colorado, United States, 80113

Delray Physician Care Center

Recruiting

Delray Beach, Florida, United States, 33445

Bioresearch Partner

Recruiting

Miami, Florida, United States, 33175

Sacred Heart Health System Inc

Recruiting

Pensacola, Florida, United States, 32504

Gulfcoast Research Institute

Recruiting

Sarasota, Florida, United States, 34232

Phoenix Clinical Research

Recruiting

Tamarac, Florida, United States, 33321

Sinai Hospital of Baltimore, Inc.

Recruiting

Baltimore, Maryland, United States, 21215

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Curalta Clinical Trials

Recruiting

Westwood, New Jersey, United States, 07675

Duke University Health System (Duke Health), Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Keystone Clinical Studies LLC, dba Flourish Research

Recruiting

Plymouth Meeting, Pennsylvania, United States, 19462

HD Research - First Surgical Hospital

Recruiting

Bellaire, Texas, United States, 77401

University of Texas (UT); Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

NextStage Clinical Research, All American Orthopedics and Sports Medicine

Recruiting

Houston, Texas, United States, 77058

Futuro Clinical Trials

Recruiting

McAllen, Texas, United States, 78501

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

Recruiting

San Antonio, Texas, United States, 78229

DRx Clinical Research, LLC; South Texas Bone and Joint Institute

Recruiting

San Antonio, Texas, United States, 78249

DRx Clinical Research, LLC

Recruiting

St. George, Utah, United States, 84770

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • Unilateral Total Knee Arthroplasty (TKA)
  • Factor XI (FXI)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-07-13.