A Phase 3, Multicenter, Randomized, Open-Label, Sponsor-Blinded, 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)

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Is undergoing a primary elective unilateral TKA

• Is in good health based on laboratory safety testing as described in the protocol

• Body weight ≤130 kg at screening visit as described in the protocol

Locations
United States
California
CARI Clinical Trials
RECRUITING
Riverside
Colorado
Denver Metro Orthopedics, P.C. Englewood Location
RECRUITING
Englewood
Florida
Gulfcoast Research Institute
RECRUITING
Sarasota
Phoenix Clinical Research
RECRUITING
Tamarac
Maryland
Sinai Hospital of Baltimore, Inc.
RECRUITING
Baltimore
Texas
HD Research - First Surgical Hospital
RECRUITING
Bellaire
Flourish Research - San Antonio (Formerly Clinical Trials of Texas)
RECRUITING
San Antonio
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2025-06-25
Estimated Completion Date: 2027-05-12
Participants
Target number of participants: 2000
Treatments
Experimental: IV REGN7508
Experimental: IV Placebo, SC REGN7508
Active_comparator: IV Placebo, apixaban
Active_comparator: IV Placebo, enoxaparin
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov