REGN7508 versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis after Total Knee Arthroplasty in Adult Participants

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Regeneron Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15]

Decision date (initial)

2026-04-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-520479-25-00

ClinicalTrials.gov

NCT07213778

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic, Pharmacokinetic, Safety

To evaluate the efficacy of IV REGN7508 for the prevention of symptomatic VTE after TKA compared to ASA

Secondary objectives 6

1. To evaluate the efficacy of IV REGN7508 for the prevention of symptomatic clinical venous thrombosis compared to ASA
2. To evaluate the clinically relevant bleeding risks of IV REGN7508 for the prevention of VTE after TKA compared to ASA
3. To evaluate the occurrence of minor bleeding following REGN7508 compared to ASA
4. To evaluate the overall safety and tolerability of IV REGN7508 in participants undergoing TKA
5. To evaluate immunogenicity following a single dose of REGN7508
6. To evaluate the PK following treatment with REGN7508

Conditions and MedDRA coding

Symptomatic Venous Thromboembolism (VTE)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Is undergoing a primary elective unilateral TKA.
2. Is in good health based on laboratory safety testing as described in the protocol
3. Other protocol-defined Inclusion criteria apply

Exclusion criteria 6

1. 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.
2. 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).
3. Has a history of thromboembolic disease or thrombophilia.
4. Has a history of platelet dysfunction.
5. Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery
6. Other protocol-defined Exclusion criteria apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of the composite endpoint of symptomatic VTE and VTE-related death

Secondary endpoints 14

1. Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT)
2. Incidence of confirmed Pulmonary Embolism (PE)
3. Incidence of VTE-related death
4. Time to first event of the composite endpoint of symptomatic VTE and VTE-related death
5. Time to first event of confirmed symptomatic DVT
6. Time to first event of confirmed PE
7. Time to VTE-related death
8. Incidence of the composite endpoint of major bleeding and Clinically Relevant Non-Major (CRNM) bleeding
9. Incidence of minor bleeding
10. Incidence of Treatment-Emergent Adverse Events (TEAEs)
11. Severity of TEAEs
12. Incidence of Anti-drug Antibody (ADA) to REGN7508
13. Magnitude of ADA to REGN7508
14. Concentrations of REGN7508

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Regeneron Pharmaceuticals Inc.

Sponsor organisation

Regeneron Pharmaceuticals Inc.

Address

777 Old Saw Mill River Road

City

Tarrytown

Postcode

10591-6717

Country

United States

Scientific contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Medical Affairs

Public contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Medical Affairs

Third parties 6

Locations

2 EU/EEA countries · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications