Phase 2
Completed N=179
A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants
Venous Thromboembolism
Source: ClinicalTrials.gov NCT06454630 ↗
Enrolled (actual)
179
Serious AEs
1.1%
Results posted
Mar 2026
Primary outcomePrimary: Percentage of Participants With Confirmed, Adjudicated Venous Thromboembolism (VTE) — 7.1; 17.2 percentage of participants
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 (TKR) 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 unilateral 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 drug less effective or could lead to side effects)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Confirmed, Adjudicated Venous Thromboembolism (VTE) |
7.1; 17.2 | — |
| SECONDARY Number of Participants With Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE) |
21.7; 28.8 | — |
| SECONDARY Percentage of Participants With Major VTE |
0; 1.7 | — |
| SECONDARY Percentage of Participants With Deep Venous Thrombosis (DVT) |
7.1; 17.2 | — |
| SECONDARY Concentrations of Total REGN7508 in Serum |
54.3; 29.2; 20.9; 6.82; 0.696 | — |
| SECONDARY Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT) |
2.80; 3.24; 1.15; 3.10; 1.06; 1.39 | — |
| SECONDARY Fold Change From Baseline in Prothrombin Time (PT) |
1.11; 0.97; 0.95; 0.96; 0.94; 0.96 | — |
| SECONDARY Number of Participants With Anti-REGN7508 Antibodies by Status |
112; 2; 0; 2 | — |
| SECONDARY Number of Participants With Treatment-Emergent or Treatment-Boosted Anti-REGN7508 Antibodies by Maximum Titer |
1; 1; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Undergoing a primary 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's) performed at screening and/or prior to administration of initial dose of study drug as described in the protocol
- Is in good health based on laboratory safety testing obtained during the screening period as described in the protocol
Key Exclusion Criteria
- History of bleeding in the past 6 months prior to dosing 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 prior to dosing
- Hospitalized (>24 hours) for any reason within 30 days of the screening visit
- Has an estimated glomerular filtration rate (GFR) of <45 mL/min/1.73m^2 at the screening visit using one of the following formulas: the Modification of Diet in Renal Disease (MDRD) equation, the Chronic Kidney Disease Epidemiology Collaboration equation, or equivalent equation
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Data sourced from ClinicalTrials.gov (NCT06454630). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.