Skip to main content
OpenTrials
Completed

NCT Number: NCT05618808

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ziekenhuis Oost-Limburg- Campus Sint-Jan, Genk, Limburg, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Undergoing elective unilateral TKA
  • Has a body weight ≤130 kg at screening visit
  • 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
  • Is in good health based on laboratory safety testing obtained during the screening period as described in the protocol

Key Exclusion Criteria:

  • 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.
  • History of thromboembolic disease or thrombophilia
  • History of major surgery, including brain, spinal, or ocular, within approximately the past 6 months.
  • History of major trauma within approximately the past 6 months.
  • Hospitalized (>24 hours) for any reason within 30 days of the screening visit
  • 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

Treatment and study plan

REGN9933

Drug

Participants will receive a single dose of REGN9933 by IV infusion

Enoxaparin

Drug

Participants will receive enoxaparin by SC administration daily through the time of venography (or day 12, whichever is earlier)

Other names: Lovenox

Apixiban

Drug

Participants will receive apixaban orally twice a day through the time of venography (or day 12, whichever is earlier)

Other names: Eliquis

Primary outcomes

  1. Percentage of Participants With Confirmed, Adjudicated Venous Thromboembolism (VTE) (REGN9933 vs Enoxaparin)

    Time frame: Through Day 12

    Composite endpoint that includes: asymptomatic deep DVT (deep venous thrombosis) detected by unilateral venography of the operated leg; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal pulmonary embolism (PE) including unexplained death for which PE cannot be ruled out

Secondary outcomes

  1. Number of Participants With Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding

    Time frame: Through Day 12

    International Society on Thrombosis and Hemostasis (ISTH) criteria for Major Bleeding and CRNM Bleeding as described in the protocol

  2. Percentage of Participants With at Least One Treatment Emergent Adverse Event (TEAE)

    Time frame: Up to Day 75

    A TEAE is any untoward medical occurrence in a participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.

  3. Percentage of Participants With Major VTE (REGN9933 vs Enoxaparin)

    Time frame: Through Day 12

    Major VTE is a composite endpoint that includes: proximal DVT; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal PE including unexplained death for which PE cannot be ruled out

  4. Percentage of Participants With DVT (REGN9933 vs Enoxaparin)

    Time frame: Through Day 12

    DVT measured by venography of the operated leg

  5. Total REGN9933 Concentrations in Serum

    Time frame: Days 0.0625 (post-dose), 4, 9, 29, and 74

    The concentrations of REGN9933 over time were summarized by descriptive statistics by study arm for the overall population

  6. Fold Change From Baseline in Activated Partial Thromboplastin Time (aPTT)

    Time frame: Days 1, 5, 10, 30, and 75

    aPTT was used to measure the anticipated anticoagulant effect of REGN9933. Fold change is based on the follow-up value/baseline value within an arm.

  7. Fold Change From Baseline in Prothrombin Time (PT)

    Time frame: Days 1, 5, 10, 30, and 75

    PT is a measure of extrinsic and/or common pathway function. Fold change is based on the follow-up value/baseline value within an arm.

  8. Number of Participants With Anti-REGN9933 Antibodies by Status

    Time frame: Through Day 75

    Immunogenicity characterized by anti-drug antibody (ADA) status

  9. Number of Participants With Treatment-Emergent or Treatment-Boosted Anti-REGN13335 Antibodies by Maximum Titer Level

    Time frame: Through Day 75

    Immunogenicity characterized per drug molecule by ADA status

  10. Percentage of Participants With Confirmed, Adjudicated VTE (Enoxaparin vs Apixaban)

    Time frame: Through Day 12

    Asymptomatic deep DVT detected by unilateral venography of the operated leg; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal pulmonary embolism (PE) including unexplained death for which PE cannot be ruled out.

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2, Multicenter, Randomized, Open-Label, Active-Control Study of REGN9933, a Factor XI Monoclonal Antibody, for Prevention of Venous Thromboembolism After Elective, Unilateral, Total Knee Arthroplasty

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 16, 2022
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.