Clinical trial NCT06454630: A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants
Official title: A Phase 2, Multicenter, Randomized, Open-Label, Active Control Study of REGN7508, a Factor XI Monoclonal Antibody, for Prevention of Venous Thromboembolism After Elective, Unilateral, Total Knee Arthroplasty (ROXI-VTE II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thromboembolism
Keywords: Anti-factor XI (FXI) monoclonal antibody
Venous thromboembolism (VTE)
Unilateral total knee arthroplasty (TKA)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-06-12
Enrollment: 179
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 (TKR) 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 unilateral 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 drug less effective or could lead to side effects)


Eligibility criteria: Key Inclusion Criteria:

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

Key Exclusion Criteria:

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 glomerular filtration rate (GFR) of \<45 mL/min/1.73m\^2 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

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Primary outcomes:
measure: Incidence of confirmed, adjudicated VTE
timeFrame: Through day 12
Secondary outcomes:
measure: Incidence of major bleeding
timeFrame: Up to approximately Day 12
measure: Incidence of clinically relevant non-major (CRNM) bleeding
timeFrame: Up to approximately Day 12
measure: Incidence of treatment emergent adverse events (TEAEs)
timeFrame: Through end of study; approximately Day 75
measure: Incidence of major VTE
timeFrame: Through day 12
measure: Incidence of Deep venous thrombosis (DVT)
timeFrame: Approximately Day 12
measure: Concentrations of REGN7508 in serum
timeFrame: Through end of study; approximately Day 75
measure: Change in activated partial thromboplastin time (aPTT)
timeFrame: Baseline to end of study; approximately Day 75
measure: Change in prothrombin time (PT)
timeFrame: Baseline to end of study; approximately Day 75
measure: Incidence of anti-drug antibodies (ADA) to REGN7508
timeFrame: Through end of study; approximately Day 75
measure: Titer of ADA to REGN7508
timeFrame: Through end of study; approximately Day 75
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Multi-profile Hospital for Active Treatment Hearth and Brain EAD
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment Park Hospital Ltd.
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Korhaz
city: Szolnok
country: Hungary
facility: Szolnoki MAV Hospital
city: Valmiera
country: Latvia
facility: Vidzemes Hospital
state: Valmieras Aprinkis
city: Liepaja
country: Latvia
facility: Liepaja Regional Hospital
city: Riga
country: Latvia
facility: Riga's 2nd Hospital
city: Riga
country: Latvia
facility: Hospital of Traumatology and Orthopaedics
city: Riga
country: Latvia
facility: Orto Klinika
city: Kaunas
country: Lithuania
facility: Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik
state: Kauno Apskritis
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences Kaunas Hospital
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital
city: Tarnow
country: Poland
facility: Specjalistyczny Szpital im. E. Szczeklika w Tarnowie
state: Malopolskie
city: Lodz
country: Poland
facility: Clinic of Orthopaedics and Paediatric Orthopaedics
state: Łódzkie
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: