A trial to learn how well REGN7508 works for preventing blood clots after a knee replacement 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], Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

27 Jun 2024 → 22 Jan 2025

Decision date (initial)

2024-06-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Regeneron Pharmaceuticals Inc.

External identifiers

EU CT number

2023-508602-14-00

ClinicalTrials.gov

NCT06454630

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic, Others, Pharmacodynamic

The primary objective of the study is to evaluate the efficacy of REGN7508 for the prevention of venous thromboembolism (VTE) after unilateral total knee arthroplasty (TKA), compared to enoxaparin

Secondary objectives 7

1. To evaluate the bleeding risk (ie, major and clinically relevant non-major (CRNM) bleeding) of REGN7508 after unilateral TKA through time of venography, compared to enoxaparin
2. To assess overall safety and tolerability of REGN7508 in participants undergoing TKA
3. To evaluate the efficacy of REGN7508 in prevention of clinically relevant VTE, compared to enoxaparin
4. To evaluate the efficacy of REGN7508 in prevention of deep venous thrombosis (DVT) detected by venography, compared to enoxaparin
5. To evaluate the pharmacokinetics of REGN7508 after single intravenous (IV) administration
6. To assess the pharmacodynamic effects of REGN7508 on intrinsic and extrinsic coagulation pathways (ie, aPTT, PT)
7. To assess immunogenicity following a single dose of REGN7508 over time

Conditions and MedDRA coding

Thromboembolic disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

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

Exclusion criteria 6

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. Has an estimated GFR of <45 mL/min/1.73m2 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence of confirmed, adjudicated VTE through day 12

Secondary endpoints 10

1. Incidence of major bleeding up to approximately day 12
2. Incidence of clinically relevant non-major (CRNM) bleeding up to approximately day 12
3. Incidence of treatment emergent adverse events (TEAEs) through end of study; approximately day 75
4. Incidence of major VTE through day 12
5. Incidence of Deep venous thrombosis (DVT) at approximately day 12
6. Concentrations of REGN7508 in serum through end of study; approximately day 75
7. Change in activated partial thromboplastin time (aPTT) baseline to end of study; approximately day 75
8. Change in prothrombin time (PT) baseline to end of study; approximately day 75
9. Incidence of anti-drug antibodies (ADA) to REGN7508 through end of study; approximately day 75
10. Titer of ADA to REGN7508 through end of study; approximately day 75

Investigational products

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

Test 1

Comparator 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 13

Locations

5 EU/EEA countries · 17 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 56 files

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

Application history

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