Actively Recruiting
A Phase 3 Study Comparing REGN7508 With Apixaban and Enoxaparin to Prevent Blood Clots After Elective Total Knee Replacement
Led by Regeneron Pharmaceuticals · Updated on 2026-05-06
2000
Participants Needed
44
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an experimental drug called REGN7508 to prevent Venous Thromboembolism (VTE) and related conditions in adults undergoing elective, one-sided total knee replacement surgery. The study also examines possible side effects, how the drug is processed in the body, and whether the body produces antibodies against the drug, which could affect its action or cause side effects. This is a Phase 3 study sponsored by Regeneron Pharmaceuticals. Participants are randomly assigned to one of several groups receiving REGN7508 through intravenous or subcutaneous routes, or active comparators like apixaban or enoxaparin, or placebo. The treatments are given according to the study protocol after surgery to assess their effects on preventing VTE. The study treatment period lasts approximately 12 days following surgery. During the study, participants will be monitored for VTE events, including symptomatic and asymptomatic cases, and for bleeding incidents up to about 14 days after surgery. Blood samples will be collected to measure drug levels and antibody responses around day 90. Safety is assessed by tracking adverse events throughout the study. The total participation duration spans from surgery through follow-up assessments up to about three months.
CONDITIONS
Brief Title
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing primary elective unilateral total knee arthroplasty (TKA)
- In good health based on laboratory safety tests as described in the protocol
- Body weight of 130 kilograms or less at screening visit
You will not qualify if you...
- Any condition that could confuse study results or increase risk as judged by the investigator
- History of bleeding needing hospitalization or transfusion within 6 months before randomization
- History of blood clotting disorders or thromboembolic disease
- History of major surgery (brain, spinal, eye) or major trauma within 6 months before randomization
- Estimated kidney function with Glomerular Filtration Rate (GFR) below 30 mL/min/1.73 m² at screening
- Other protocol-defined exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants receive one of the study drugs (REGN7508, Apixaban, Enoxaparin, or Placebo) following their total knee replacement surgery to prevent blood clots.
Approximately 1 to 2 visits during treatment
Duration - Up to approximately 90 days
Participants are monitored for safety, including bleeding events and immune response, after completing the treatment period.
1 visit (in-person)
Trial Site Locations
Total: 44 locations
1
Shoals Medical Trials, Inc.
Sheffield, Alabama, United States, 35660
Actively Recruiting
2
CARI Clinical Trials
Riverside, California, United States, 92504
Actively Recruiting
3
Denver Metro Orthopedics, P.C. Englewood Location
Englewood, Colorado, United States, 80113
Actively Recruiting
4
Delray Physician Care Center
Delray Beach, Florida, United States, 33445
Actively Recruiting
5
Bioresearch Partner
Miami, Florida, United States, 33175
Actively Recruiting
6
Sacred Heart Health System Inc
Pensacola, Florida, United States, 32504
Actively Recruiting
7
Gulfcoast Research Institute
Sarasota, Florida, United States, 34232
Actively Recruiting
8
Phoenix Clinical Research
Tamarac, Florida, United States, 33321
Actively Recruiting
9
Sinai Hospital of Baltimore, Inc.
Baltimore, Maryland, United States, 21215
Actively Recruiting
10
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
11
Curalta Clinical Trials
Westwood, New Jersey, United States, 07675
Actively Recruiting
12
Duke University Health System (Duke Health), Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
13
Keystone Clinical Studies LLC, dba Flourish Research
Plymouth Meeting, Pennsylvania, United States, 19462
Actively Recruiting
14
HD Research - First Surgical Hospital
Bellaire, Texas, United States, 77401
Actively Recruiting
15
University of Texas (UT); Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
16
NextStage Clinical Research, All American Orthopedics and Sports Medicine
Houston, Texas, United States, 77058
Actively Recruiting
17
Futuro Clinical Trials
McAllen, Texas, United States, 78501
Actively Recruiting
18
Flourish Research - San Antonio (Formerly Clinical Trials of Texas)
San Antonio, Texas, United States, 78229
Actively Recruiting
19
DRx Clinical Research, LLC
St. George, Utah, United States, 84770
Actively Recruiting
20
Multi-profile Hospital for Active Treatment Hearth and Brain EAD
Pleven, Bulgaria, 5804
Actively Recruiting
21
Multiprofile Hospital for Active Treatment; Sveta Sofia EOOD (MBAL Sveta Sofia),
Sofia, Bulgaria, 1404
Actively Recruiting
22
University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich"
Stara Zagora, Bulgaria, 6003
Actively Recruiting
23
Gyor-Moson-Sopron Varmegyei Egyetemi Oktato Korhaz
Győr, Győr-Moson-Sopron, Hungary, 9024
Actively Recruiting
24
University of Debrecen
Debrecen, Hajdú-Bihar, Hungary, 4031
Actively Recruiting
25
Semmelweis University
Budapest, Hungary, 1082
Actively Recruiting
26
Kansai Rosai Hospital
Amagasaki-shi, Hyōgo, Japan, 660-8511
Actively Recruiting
27
Yuuai Medical Center
Tomigusuku, Okinawa, Japan, 901-0224
Actively Recruiting
28
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, Osaka, Japan, 586-8521
Actively Recruiting
29
Osaka Saiseikai Nakatsu Hospital
Kita-Ku, Osaka, Japan, 530-0012
Actively Recruiting
30
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431
Actively Recruiting
31
Saga University Hospital
Saga, Japan, 849-8501
Actively Recruiting
32
Liepajas regionala slimnica; SIA
Liepāja, Latvia, LV-3414
Actively Recruiting
33
Rigas 2 slimnica, SIA
Riga, Latvia, LV-1004
Actively Recruiting
34
Hospital of Traumatology and Orthopaedics
Riga, Latvia, LV-1005
Actively Recruiting
35
ORTO Klinika
Riga, Latvia, LV-1005
Actively Recruiting
36
Vidzemes slimnica
Valmiera, Latvia, LV-4201
Actively Recruiting
37
Lietuvos sveikatos mokslu universiteto Kauno ligonine
Kaunas, Lithuania, LT-47144
Actively Recruiting
38
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik
Kaunas, Lithuania, LT-50161
Actively Recruiting
39
Vsi Klaipedos Universitetine Ligonine
Klaipėda, Lithuania, LT-92288
Actively Recruiting
40
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. z o.o.
Krakow, Poland, 31-826
Actively Recruiting
41
Uniwersytecki Szpital Kliniczny nr.2 Uniwersytetu Medycznego w Lodzi
Lodz, Poland, 90-549
Actively Recruiting
42
Samodzieny Publiczny Zaklad Opieki Zdorowotne (SP ZOZ) Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi - Hematology
Lodz, Poland, 92-213
Actively Recruiting
43
Arensia Clinics S.R.L
Bucharest, Romania, 011658
Actively Recruiting
44
ARENSIA Exploratory Medicine, County Hospital Cluj-Napoca
Cluj-Napoca, Romania, 400006
Actively Recruiting
Research Team
C
Clinical Trials Administrator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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