REGN7508 + REGN9933 for Peripheral Artery Disease

(ROXI-PALISADE Trial)

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Regeneron Pharmaceuticals

Must not be taking: Anticoagulants

Disqualifiers: Bleeding disorders, Recent coronary revascularization, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately up to 42 months

7050 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new drugs, REGN7508 and REGN9933, to determine if they can prevent dangerous blood clots in individuals with Peripheral Artery Disease (PAD) who have recently undergone a procedure to improve leg blood flow. The study compares these drugs to rivaroxaban, a common blood thinner, and a placebo (a harmless pill with no active medicine). It also examines potential side effects, how the body processes the drugs, and any risk of rejection. Suitable participants have recently had a leg procedure due to PAD and may also have conditions like diabetes requiring medication or heart disease. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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

Research has shown that both REGN7508 and REGN9933 were safe in earlier studies focused on preventing blood clots after certain surgeries. Specifically, REGN7508 proved more effective than enoxaparin, a common blood thinner, in preventing blood clots without increasing the risk of major bleeding. Although REGN9933 was not always superior to enoxaparin, it remained effective and did not cause serious bleeding.

These results suggest that both drugs are generally safe with manageable side effects. It is important to note that these findings come from studies similar to the current one, which tests the drugs for safety and effectiveness in people with Peripheral Artery Disease (PAD). ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of REGN7508 and REGN9933 for treating Peripheral Artery Disease (PAD) because these treatments offer a novel approach compared to current options like lifestyle changes, statins, and antiplatelet drugs. Unlike standard treatments that primarily manage symptoms and risk factors, REGN7508 and REGN9933 work by targeting specific molecular pathways involved in vascular inflammation and repair, potentially addressing the underlying causes of PAD. Additionally, the inclusion of Rivaroxaban, an anticoagulant, aims to enhance the efficacy by preventing blood clot formation, which is a common complication in PAD. This innovative approach could lead to more effective management of the disease and improve patients' quality of life.

What evidence suggests that this trial's treatments could be effective for Peripheral Artery Disease?

This trial will evaluate the combination of REGN7508 and REGN9933 for Peripheral Artery Disease (PAD). Studies have shown that this combination can help prevent blood clots in individuals with conditions like PAD. Specifically, research indicates that REGN7508 outperformed enoxaparin, a common blood thinner, in preventing clots after surgery. Although REGN9933 showed potential, it was not always more effective than enoxaparin. Both drugs target a protein called Factor XI, which plays a role in blood clot formation. Early findings suggest these drugs could reduce the risk of dangerous blood clots after procedures that improve blood flow in the legs. ^{1 2 3 5 6}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with peripheral artery disease (PAD) who recently had a procedure to improve blood flow in their legs. Participants may have other health issues like heart disease, kidney problems, diabetes needing treatment, or be age 75 or older.

Inclusion Criteria

I have had a limb procedure or amputation for PAD before my most recent event.

I have heart disease that causes symptoms.

I have chronic kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either REGN7508, REGN9933, rivaroxaban, or placebo to evaluate the prevention of blood clots after Lower Extremity Revascularization

Approximately up to 42 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the occurrence of thrombotic events and adverse effects

Approximately up to 45 months

What Are the Treatments Tested in This Trial?

Interventions

• REGN7508
• REGN9933
• Rivaroxaban

Trial Overview

The study compares two new drugs (REGN7508 and REGN9933), rivaroxaban (a standard blood thinner), and placebo to see which best prevents dangerous blood clots after leg procedures in people with PAD. Participants are randomly assigned to one of these treatments.

How Is the Trial Designed?

Group I: Cohort 2 Experimental Treatment 3 Interventions

Group II: Cohort 1 Experimental Treatment 3 Interventions

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/study/NCT07318610

Study Details | NCT07318610 | Reducing Adverse ...

The aim of this study is to see how well REGN7508 and REGN9933 prevent life-threatening blood clots in participants with PAD who have recently ...

2.

trial.medpath.com

trial.medpath.com/clinical-trial/1527835b31acfdcc/nct07318610-regen7508-regen9933-factor-xi-antibodies-peripheral-artery-disease

Reducing Adverse Vascular Outcomes With Factor XI ...

The aim of this study is to see how well REGN7508 and REGN9933 prevent life-threatening blood clots in participants with PAD who have recently had LER. The ...

3.

investor.regeneron.com

investor.regeneron.com/news-releases/news-release-details/phase-2-trials-demonstrating-antithrombotic-effect-two-novel

Phase 2 Trials Demonstrating Antithrombotic Effect of Two ...

As published and presented, the results showed that both REGN7508Cat and REGN9933A2 demonstrated clear efficacy for VTE prevention following ...

4.

synapse.patsnap.com

synapse.patsnap.com/drug/4f3e100eb20e455c9254f47d61bbc953

REGN-7508 - Drug Targets, Indications, Patents

The findings with REGN7508Cat confirm the role of FXI in postoperative venous thromboembolism, and the findings with REGN9933A2 suggest that ...

5.

ctv.veeva.com

ctv.veeva.com/study/reducing-adverse-vascular-outcomes-with-factor-xi-inhibition-in-adult-participants-with-peripheral-a

Reducing Adverse Vascular Outcomes With Factor XI ...

This study is researching 2 different experimental drugs called REGN7508 and REGN9933. The study is focused on people who have Peripheral ...

6.

sigma.larvol.com

sigma.larvol.com/product.php?e1=992445&tab=newstrac

REGN9933 News

REGN7508Cat was superior to enoxaparin for VTE prevention; REGN9933A2 was not superior to enoxaparin. The results with REGN7508Cat confirm the role of FXI in ...