A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants

Venous Thromboembolism Clinical Trial

— ROXI-VTE II  

Official title:

A Phase 2, Multicenter, Randomized, Open-Label, Active Control Study of REGN7508, a Factor XI Monoclonal Antibody, for Prevention of Venous Thromboembolism After Elective, Unilateral, Total Knee Arthroplasty (ROXI-VTE II)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06454630
• Other study ID #: R7508-DVT-2360
• Secondary ID: 2023-508602-14-0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 10, 2024
• Est. completion date: March 26, 2025

Study information

• Verified date: June 2024
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 your 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: March 26, 2025
• Est. primary completion date: March 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Key Inclusion Criteria:

1. Undergoing a primary elective unilateral TKA

2. Has a body weight =130 kg at screening visit

3. 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

4. Is in good health based on laboratory safety testing obtained during the screening period as described in the protocol

Key Exclusion Criteria:

1. 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

2. History of thromboembolic disease or thrombophilia

3. History of major surgery, including brain, spinal, or ocular, within approximately the past 6 months

4. History of major trauma within approximately the past 6 months prior to dosing

5. Hospitalized (>24 hours) for any reason within 30 days of the screening visit

6. Using the Modification of Diet in Renal Disease (MDRD) equation, has an estimated glomerular filtration rate (GFR) of <45 mL/min/1.73m^2, as described in the protocol

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• REGN7508
Administered by single intravenous (IV) dose
• Enoxaparin
Administered by subcutaneous (SC) dose daily through the time of venography (or day 12, whichever is earlier)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of confirmed, adjudicated VTE		Through day 12
Secondary	Incidence of major bleeding		Up to approximately Day 12
Secondary	Incidence of clinically relevant non-major (CRNM) bleeding		Up to approximately Day 12
Secondary	Incidence of treatment emergent adverse events (TEAEs)		Through end of study; approximately Day 75
Secondary	Incidence of major VTE		Through day 12
Secondary	Incidence of Deep venous thrombosis (DVT)		Approximately Day 12
Secondary	Concentrations of REGN7508 in serum		Through end of study; approximately Day 75
Secondary	Change in activated partial thromboplastin time (aPTT)		Baseline to end of study; approximately Day 75
Secondary	Change in prothrombin time (PT)		Baseline to end of study; approximately Day 75
Secondary	Incidence of anti-drug antibodies (ADA) to REGN7508		Through end of study; approximately Day 75
Secondary	Titer of ADA to REGN7508		Through end of study; approximately Day 75