Frontlight ResearchEarly access
Taking people in United StatesPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Key facts
- Who runs it
- Regeneron Pharmaceuticals
- Where
- Baltimore, Bellaire, Boston, Dallas, Delray Beach, Durham, Englewood, Houston, McAllen, Miami, Pensacola, Plymouth Meeting, Riverside, San Antonio, Sarasota, Sheffield, St. George, Tamarac, and Westwood, United StatesSee the 20 sitesAlso in 7 other countries, 27 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 2,000 people, planned
- Started
- 25 Jun 2025
- Expected to end
- 12 May 2027
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- REGN7508
- Apixaban
- Enoxaparin
- Placebo
- Record updated
- 6 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Is undergoing a primary elective unilateral TKA
- Is in good health based on laboratory safety testing as described in the protocol
- Body weight ≤130 kg at screening visit as described in the protocol
Who cannot take part
- History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol
- History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization
- 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
- History of thromboembolic disease or thrombophilia
- 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
Where in United States
Also in 7 other countries, 27 sites
- Sinai Hospital of Baltimore, Inc.Baltimore, United StatesContact: Clinical Trials AdministratorTaking people
- HD Research - First Surgical HospitalBellaire, United StatesContact: Clinical Trials AdministratorTaking people
- Brigham and Women's HospitalBoston, United StatesContact: Clinical Trials AdministratorTaking people
- University of Texas (UT) Southwestern Medical CenterDallas, United StatesContact: Clinical Trials AdministratorTaking people
- Delray Physician Care CenterDelray Beach, United StatesContact: Clinical Trials AdministratorTaking people
- Duke University Health System (Duke Health), Duke University HospitalDurham, United StatesContact: Clinical Trials AdministratorTaking people
- Denver Metro Orthopedics, P.C. Englewood LocationEnglewood, United StatesContact: Clinical Trials AdministratorTaking people
- NextStage Clinical Research, All American Orthopedics and Sports MedicineHouston, United StatesContact: Clinical Trials AdministratorNo longer taking part
- Futuro Clinical TrialsMcAllen, United StatesContact: Clinical Trials AdministratorTaking people
- Bioresearch PartnerMiami, United StatesContact: Clinical Trials AdministratorTaking people
- Sacred Heart Health System IncPensacola, United StatesContact: Clinical Trials AdministratorTaking people
- Keystone Clinical Studies LLC, dba Flourish ResearchPlymouth Meeting, United StatesContact: Clinical Trials AdministratorNo longer taking part
- CARI Clinical TrialsRiverside, United StatesContact: Clinical Trials AdministratorTaking people
- DRx Clinical Research, LLC; South Texas Bone and Joint InstituteSan Antonio, United StatesContact: Clinical Trials AdministratorTaking people
- Flourish Research - San Antonio (Formerly Clinical Trials of Texas)San Antonio, United StatesContact: Clinical Trials AdministratorTaking people
- Gulfcoast Research InstituteSarasota, United StatesContact: Clinical Trials AdministratorTaking people
- Shoals Medical Trials, Inc.Sheffield, United StatesContact: Clinical Trials AdministratorTaking people
- DRx Clinical Research, LLCSt. George, United StatesContact: Clinical Trials AdministratorTaking people
- Phoenix Clinical ResearchTamarac, United StatesContact: Clinical Trials AdministratorTaking people
- Curalta Clinical TrialsWestwood, United StatesContact: Clinical Trials AdministratorTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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)
The 4 groups in the trial
- IV REGN7508Treatment being tested
Treatment: REGN7508
- IV Placebo, SC REGN7508Treatment being tested
Treatment: REGN7508 and Placebo
- IV Placebo, apixabanExisting treatment, for comparison
Treatment: Apixaban and Placebo
- IV Placebo, enoxaparinExisting treatment, for comparison
Treatment: Enoxaparin and Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 3, Multicenter, Randomized, Open-Label, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX)
- Record updated
- 6 November 2026