REGN9933 for Preventing Blood Clots After Knee Surgery

No longer recruiting at 23 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called REGN9933 to determine its effectiveness in preventing blood clots after knee replacement surgery, compared to enoxaparin and apixaban, the current options. It also evaluates the safety of REGN9933 and any potential bleeding issues. Individuals scheduled for a single knee replacement and weighing 130 kg or less may qualify for this study. The trial will compare the effectiveness of these treatments and how the body processes REGN9933. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the safety of REGN9933 is still under investigation. Earlier studies have not yet provided clear information about how well people tolerate it. This trial is in an early stage, focusing mainly on assessing the treatment's safety and participants' reactions. Researchers closely monitor participants for any side effects.

Early trials like this one often aim to determine if the treatment causes side effects and their severity. Since REGN9933 is still under testing, no regulatory body, such as the FDA, has approved it for use. Participants should understand that the trial will contribute to learning more about the treatment's effects and safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

REGN9933 is unique because it is administered through an intravenous (IV) infusion, which is different from standard treatments like Enoxaparin and Apixaban that are given subcutaneously or orally. While most treatments for preventing blood clots after knee surgery rely on these more traditional delivery methods, REGN9933’s IV administration could offer a new approach to delivering medication directly into the bloodstream. Researchers are excited about the potential for this new method to improve the speed and efficiency of treatment, possibly leading to quicker recovery times for patients.

What evidence suggests that this trial's treatments could be effective for preventing blood clots after knee surgery?

This trial will compare REGN9933 with Enoxaparin and Apixaban in preventing blood clots after knee replacement surgery. Research has shown that REGN9933 yields promising results in clot prevention. Specifically, earlier studies indicated that patients taking REGN9933 experienced fewer blood clots, demonstrating its effectiveness in stopping clot formation. This medication targets Factor XI, a crucial component in clot formation. By blocking Factor XI, REGN9933 is believed to reduce the risk of clots without increasing bleeding. Although more information is needed, these findings suggest that REGN9933 could be a viable option for preventing blood clots after surgery. ^{1 2 3 4 5}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT05618808

NCT05618808 | A Trial to Learn How Well REGN9933 ...

The primary objective of the study is to evaluate the efficacy of REGN9933 for the prevention of venous thromboembolism (VTE) after unilateral total knee ...

2.

clinicaltrials.regeneron.com

clinicaltrials.regeneron.com/clinical-trials/a0Mdy00000019KdEAI/nct05618808

A Trial to Learn How Well REGN9933 Works for Preventing ...

The primary objective of the study is to evaluate the efficacy of REGN9933 for the prevention of venous thromboembolism (VTE) after unilateral total knee ...

3.

withpower.com

withpower.com/trial/phase-2-thromboembolism-2023-5cb31

REGN9933 for Preventing Blood Clots After Knee Surgery

This trial is testing REGN9933, a new medication, to see if it can prevent blood clots in patients having knee replacement surgery.

4.

investor.regeneron.com

investor.regeneron.com/news-releases/news-release-details/regeneron-advance-two-factor-xi-antibodies-broad-phase-3-program

Regeneron to Advance Two Factor XI Antibodies into a ...

... REGN9933 administered 12 to 24 hours after total knee replacement demonstrated robust antithrombotic effects. Phase 3 program to be initiated ...

5.

clinicaltrials.eu

clinicaltrials.eu/inn/regn9933/

REGN9933: A New Potential Treatment for Blood Clots

REGN9933 is being studied for preventing VTE in patients undergoing knee replacement surgery and in those with a peripherally inserted central catheter (PICC ...