REGN7508 for Venous thromboembolism (VTE)

Inclusion criteria

• {"criterion_text":"- Is undergoing a primary elective unilateral TKA.\n- Is in good health based on laboratory safety testing as described in the protocol\n- Other protocol-defined Inclusion criteria apply"}

Exclusion criteria

• {"criterion_text":"- Has 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.\n- Has a history of bleeding in the 6 months prior to randomization 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 (eg, hemophilia A or B, von Willebrand’s Factor deficiency).\n- Has a history of thromboembolic disease or thrombophilia.\n- Has a history of platelet dysfunction.\n- Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery\n- Other protocol-defined Exclusion criteria apply"}

Primary endpoints

• {"endpoint_text":"- Incidence of the composite endpoint of symptomatic VTE and VTE-related death","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT)\n- Incidence of confirmed Pulmonary Embolism (PE)\n- Incidence of VTE-related death\n- Time to first event of the composite endpoint of symptomatic VTE and VTE-related death\n- Time to first event of confirmed symptomatic DVT\n- Time to first event of confirmed PE\n- Time to VTE-related death\n- Incidence of the composite endpoint of major bleeding and Clinically Relevant Non-Major (CRNM) bleeding\n- Incidence of minor bleeding\n- Incidence of Treatment-Emergent Adverse Events (TEAEs)\n- Severity of TEAEs\n- Incidence of Anti-drug Antibody (ADA) to REGN7508\n- Magnitude of ADA to REGN7508\n- Concentrations of REGN7508","definition_or_measurement_approach":""}

Methods

• Recruitment activity delegated to third-party organisations (examples listed in CTIS): Clariness GmbH (role: Recruitment) - no channel details provided in available data; Optimapharm Greece Consulting Research S.A. (local sponsor contact/support) - no channel details provided; Parexel International (IRL) Limited (CRO) - no channel details provided.
• Country-specific recruitment documents exist (K1_Recruitment Arrangements) for Greece and Italy but text not available in extracted data.

Greece

Earliest CTIS Part Ii Submission Date

21-01-2026

Latest Decision Or Authorization Date

01-04-2026

Processing Time Days

70

Number Of Sites

3

Number Of Participants

40

Italy

Earliest CTIS Part Ii Submission Date

09-03-2026

Latest Decision Or Authorization Date

07-04-2026

Processing Time Days

29

Number Of Sites

2

Number Of Participants

18

Primary sponsor

Full Name

Regeneron Pharmaceuticals Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

CRO

Third parties

• {"country":"Greece","full_name":"Optimapharm Greece Consulting Research Single Member S.A.","duties_or_roles":"Sponsor duties codes: 1, 5 (as listed in CTIS)","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Sponsor duty code: 3 (as listed in CTIS)","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Recruitment","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Slovakia","full_name":"SanaClis s.r.o.","duties_or_roles":"Investigational Product Storage – Distribution, Return and Destruction","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}