A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery in Adult Participants

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Venous Thromboembolism

Treatments: Drug: Apixiban; Drug: REGN9933; Drug: Enoxaparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05618808

R9933-DVT-2230

2022-501470-18-00 (Other Identifier)

Details and patient eligibility

About

The primary objective of the study is to evaluate the efficacy of REGN9933 for the prevention of venous thromboembolism (VTE) after unilateral total knee arthroplasty (TKA), compared to enoxaparin

The secondary objectives of the study are:

• To evaluate the bleeding risk (ie, major and clinically relevant non-major [CRNM] bleeding) of REGN9933 after unilateral TKA through time of venography, compared to enoxaparin
• To assess overall safety and tolerability of REGN9933 in participants undergoing TKA
• To evaluate the efficacy of REGN9933 in prevention of clinically relevant VTE, compared to enoxaparin
• To evaluate the efficacy of REGN9933 in prevention of deep venous thrombosis (DVT) detected by venography, compared to enoxaparin
• To evaluate the pharmacokinetics (PK) of REGN9933 after single intravenous (IV) administration
• To assess pharmacodynamic (PD) effects of REGN9933 on intrinsic and extrinsic coagulation pathways
• To assess immunogenicity following a single dose of REGN9933 over time
• To compare the efficacy of enoxaparin and apixaban in prevention of VTE after unilateral TKA

Enrollment: 373 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Undergoing 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) performed at screening and/or prior to administration of initial dose of study drug
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 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.
5. Hospitalized (>24 hours) for any reason within 30 days of the screening visit
6. Using the Modification of Diet in Renal Disease equation, has an estimated glomerular filtration rate as described in the protocol

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

373 participants in 3 patient groups

REGN9933

Experimental group

Description:

REGN9933 will be administered by intravenous (IV) infusion

Treatment:

Drug: REGN9933

Enoxaparin

Active Comparator group

Description:

Enoxaparin will be administered by subcutaneous (SC) administration

Treatment:

Drug: Enoxaparin

Apixaban

Active Comparator group

Description:

Apixaban will be administered orally twice a day

Treatment:

Drug: Apixiban