REGN7508 versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults.

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] - Cardiovascular Diseases [C14], Diseases [C] - Hemic and Lymphatic Diseases [C15]

Trial duration

5 Nov 2025 → ongoing

Decision date (initial)

2025-10-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Pharmacodynamic, Efficacy, Pharmacokinetic

To evaluate the efficacy of IV REGN7508 for the prevention of VTE after TKA compared to enoxaparin and apixaban.

Secondary objectives 9

1. To evaluate the efficacy of IV REGN7508 for the prevention of clinical thrombosis compared to enoxaparin and apixaban.
2. To evaluate the clinically relevant bleeding risk of IV REGN7508 for the prevention of VTE after TKA compared to enoxaparin and apixaban.
3. To evaluate the efficacy of SC REGN7508 for the prevention of VTE after TKA compared to enoxaparin and apixaban.
4. To evaluate the efficacy of SC REGN7508 for the prevention of clinical thrombosis compared to enoxaparin and apixaban.
5. To evaluate the clinically relevant bleeding risk of SC REGN7508 for the prevention of VTE after TKA compared to enoxaparin and apixaban.
6. To evaluate the occurrence of minor bleeding following IV REGN7508 and SC REGN7508 compared to enoxaparin and apixaban.
7. To evaluate the overall safety and tolerability of IV REGN7508 and SC REGN7508 in participants undergoing TKA.
8. To evaluate immunogenicity following treatment with REGN7508.
9. To evaluate pharmacokinetics (PK) following treatment with REGN7508.

Conditions and MedDRA coding

Thromboembolic disease

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 4

1. Is undergoing a primary elective unilateral TKA .
2. Is in good health based on laboratory safety testing as described in the protocol.
3. Body weight <130 kg at screening visit as described in the protocol.
4. Other protocol-defined Inclusion Criteria apply.

Exclusion criteria 6

1. 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. History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol.
3. History of thromboembolic disease or thrombophilia.
4. History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization.
5. Has an estimated Glomerular Filtration Rate (GFR) of <30 mL/min/1.73 m2 at the screening visit as described in the protocol.
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 asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death].

Secondary endpoints 10

1. Incidence of confirmed symptomatic Deep Venous Thrombosis (DVT).
2. Incidence of confirmed Pulmonary Embolism (PE).
3. Incidence of VTE-related death.
4. Incidence of the composite endpoint of major and clinically relevant nonmajor (CRNM) bleeding.
5. Incidence of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death).
6. Incidence of minor bleeding.
7. Incidence of Treatment Emergent Adverse Events (TEAEs).
8. Incidence of Anti-Drug Antibodies (ADA) to REGN7508.
9. Titer of ADA to REGN7508.
10. Concentrations of REGN7508.

Investigational products

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

Test 2

Comparator 2

Placebo 1

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

6 EU/EEA countries · 23 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 73 files

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

Application history

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