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

NCT07015905
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
2,000
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Lead sponsor
Regeneron Pharmaceuticals
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Start date
2025-06-25
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Number of sites
46
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Summary
This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery. The aim of the study is to see how effective the study drug is at preventing Venous Thromboembolism (VTE) and other related diseases after total knee replacement surgery. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
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Acronym
ROXI-APEX
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Short title
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
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Official title
A Phase 3, Multicenter, Randomized, Open-Label, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-05-12
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First posted
2025-06-11
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Registry last updated
2026-07-13
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Primary completion date
2027-02-20
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Start date
2025-06-25
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Participants
2,000
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Participant count basis
Estimated
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Planned participants
2,000
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Protocol amendments
3
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Number of sites
46
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Regeneron Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07015905
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ClinicalTrials.gov ID
NCT07015905
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death]

    Timeframe: Through day 12 visit, approximately 14 days

  1. Time-to-first event of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death)

    Timeframe: Through day 12 visit, approximately 14 days

  2. Incidence of confirmed symptomatic Deep Venous Thrombosis (DVT)

    Timeframe: Through day 12 visit, approximately 14 days

  3. Incidence of confirmed Pulmonary Embolism (PE)

    Timeframe: Through day 12 visit, approximately 14 days

  4. Incidence of VTE-related death

    Timeframe: Through day 12 visit, approximately 14 days

  5. Time-to-first event of confirmed symptomatic DVT

    Timeframe: Through day 12 visit, approximately 14 days

  6. Time-to-first event of confirmed PE

    Timeframe: Through day 12 visit, approximately 14 days

  7. Time to VTE-related death

    Timeframe: Through day 12 visit, approximately 14 days

  8. Incidence of the composite endpoint of major and Clinically Relevant Non-Major (CRNM) bleeding

    Timeframe: Through day 12 visit, approximately 14 days

  9. Incidence of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death)

    Timeframe: Through day 12 visit, approximately 14 days

  10. Incidence of minor bleeding

    Timeframe: Through day 12 visit, approximately 14 days

  11. Incidence of Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Approximately day 90

  12. Occurrence of Anti-Drug Antibodies (ADA) to REGN7508

    Timeframe: Approximately day 90

  13. Magnitude of ADA to REGN7508

    Timeframe: Approximately day 90

  14. Concentrations of REGN7508

    Timeframe: Approximately day 90

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

Key Inclusion Criteria:

  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

Key Exclusion Criteria:

  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

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Sources for eligibility
clinicaltrials.gov

  • Shoals Medical Trials, Inc.Sheffield, United StatesRecruiting
  • CARI Clinical TrialsRiverside, United StatesRecruiting
  • Denver Metro Orthopedics, P.C. Englewood LocationEnglewood, United StatesRecruiting
  • Delray Physician Care CenterDelray Beach, United StatesRecruiting
  • Bioresearch PartnerMiami, United StatesRecruiting
  • Sacred Heart Health System IncPensacola, United StatesRecruiting
  • Gulfcoast Research InstituteSarasota, United StatesRecruiting
  • Phoenix Clinical ResearchTamarac, United StatesRecruiting
  • Sinai Hospital of Baltimore, Inc.Baltimore, United StatesRecruiting
  • Brigham and Women's HospitalBoston, United StatesRecruiting
  • Curalta Clinical TrialsWestwood, United StatesRecruiting
  • Duke University Health System (Duke Health), Duke University HospitalDurham, United StatesRecruiting
  • Keystone Clinical Studies LLC, dba Flourish ResearchPlymouth Meeting, United StatesRecruiting
  • HD Research - First Surgical HospitalBellaire, United StatesRecruiting
  • University of Texas (UT); Southwestern Medical CenterDallas, United StatesRecruiting
  • NextStage Clinical Research, All American Orthopedics and Sports MedicineHouston, United StatesRecruiting
  • Futuro Clinical TrialsMcAllen, United StatesRecruiting
  • Flourish Research - San Antonio (Formerly Clinical Trials of Texas)San Antonio, United StatesRecruiting
  • DRx Clinical Research, LLC; South Texas Bone and Joint InstituteSan Antonio, United StatesRecruiting
  • DRx Clinical Research, LLCSt. George, United StatesRecruiting
  • Multi-profile Hospital for Active Treatment Hearth and Brain EADPleven, BulgariaRecruiting
  • Multiprofile Hospital for Active Treatment; Sveta Sofia EOOD (MBAL Sveta Sofia),Sofia, BulgariaRecruiting
  • Stara Zagora, BulgariaRecruiting
  • Szegedi Tudomanyegyetem; Albert Szent-Gyorgyi Clinical CenterSzeged, HungaryRecruiting
  • Gyor-Moson-Sopron Varmegyei Egyetemi Oktato KorhazGyőr, HungaryRecruiting

And 21 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-520478-20-00
Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (1)

Targets (4)