REGN9933 for Preventing Blood Clots After Knee Surgery

Recruiting at 18 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Regeneron Pharmaceuticals

Disqualifiers: Bleeding history, Thromboembolic disease, Major surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 days

373 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing REGN9933, a new medication, to see if it can prevent blood clots in patients having knee replacement surgery. The medication works by stopping clots from forming in the blood vessels.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

Adults in good health needing knee replacement surgery can join this trial. They should weigh no more than 130 kg and have stable vital signs, normal ECG, and lab tests. People with recent bleeding issues, thromboembolic disease, major surgeries or trauma within the last 6 months, or severe kidney problems cannot participate.

Inclusion Criteria

Is in good health based on laboratory safety testing obtained during the screening period as described in the protocol

My weight is 130 kg or less.

I am scheduled for a knee replacement surgery on one knee.

Exclusion Criteria

I have a history of blood clots or clotting disorders.

Your kidney function, as calculated using a specific equation, falls within the range specified in the study protocol.

I have not had serious bleeding issues or needed a blood transfusion in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive REGN9933 or comparator drugs (enoxaparin or apixaban) for prevention of VTE after knee arthroplasty

12 days

Daily administration

Follow-up

Participants are monitored for safety, efficacy, and immunogenicity of REGN9933

Approximately 75 days

Treatment Details

Interventions

• REGN9933

Trial Overview The study is testing REGN9933's effectiveness at preventing blood clots after knee surgery compared to enoxaparin. It will also compare the risk of bleeding between these drugs and assess REGN9933's overall safety and how it affects blood clotting pathways.

Participant Groups

Group I: REGN9933 Experimental Treatment 1 Intervention

REGN9933 will be administered by intravenous (IV) infusion

Group II: Enoxaparin Active Control 1 Intervention

Enoxaparin will be administered by subcutaneous (SC) administration

Group III: Apixaban Active Control 1 Intervention

Apixaban will be administered orally twice a day

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School