99 Participants NeededMy employer runs this trial

REGN13335 for Pulmonary Arterial Hypertension

(ILLUMINATE Trial)

Recruiting at 29 trial locations
CT
Overseen ByClinical Trials Administrator
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Regeneron Pharmaceuticals
Must be taking: PAH medicines
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an experimental drug called REGN13335 to determine its safety and effectiveness for individuals with Pulmonary Arterial Hypertension (PAH), a condition that causes high blood pressure in the lungs. Researchers aim to identify potential side effects, understand how the body processes the drug, and assess whether the body produces antibodies that could impact its effectiveness. Participants must have a PAH diagnosis, exhibit noticeable symptoms affecting daily activities, and currently take other PAH medications. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial does not require you to stop taking your current PAH medications. In fact, you need to be on a stable dose of your existing PAH treatment to participate.

Is there any evidence suggesting that REGN13335 is likely to be safe for humans?

Earlier studies tested REGN13335 in adults with pulmonary arterial hypertension (PAH) to assess its safety alongside other PAH medications. Some participants experienced side effects, but overall, the treatment was generally well-tolerated. The available data reported no serious side effects. Researchers also measured the levels of REGN13335 in the blood and monitored for antibody production against it. These assessments help ensure the treatment's effectiveness and safety. While ongoing studies will provide more information, early results suggest that REGN13335 is safe for further testing in people with PAH.12345

Why do researchers think this study treatment might be promising for PAH?

Unlike the standard treatments for pulmonary arterial hypertension, which often include endothelin receptor antagonists, phosphodiesterase-5 inhibitors, or prostacyclin analogs, REGN13335 works by a different mechanism. This investigational treatment is designed to target specific pathways involved in the disease, potentially offering a new way to manage symptoms and improve patient outcomes. Researchers are excited about REGN13335 because it could provide an alternative for patients who don't respond well to existing therapies, offering hope for more personalized and effective treatment options.

What evidence suggests that REGN13335 might be an effective treatment for Pulmonary Arterial Hypertension?

Research has shown that REGN13335 could be a promising treatment for Pulmonary Arterial Hypertension (PAH). Studies have found that this drug blocks a protein called PDGF-B, which supports the growth and health of blood vessels. By inhibiting this protein, REGN13335 may help lower pressure in the lung arteries. In animal studies, it improved heart function and reduced disease symptoms. Although research in humans is ongoing, these early results suggest it could offer a new treatment option for PAH without relying on widening blood vessels. Participants in this trial will join different arms, including experimental arms and a placebo comparator, to further evaluate the effectiveness and safety of REGN13335.12345

Who Is on the Research Team?

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with pulmonary arterial hypertension (PAH) who are already on stable PAH medications. Participants should have moderate symptoms and be able to walk between 150 and 550 meters in a six-minute test.

Inclusion Criteria

I am on a stable treatment plan for PAH as decided by my doctor.
I have been diagnosed with pulmonary arterial hypertension.
My heart's resistance to blood flow is high, as shown by a specific heart test.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive REGN13335 or placebo to assess efficacy and safety in PAH

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may continue receiving REGN13335 to assess long-term effects

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • REGN13335

Trial Overview

The study tests an experimental drug called REGN13335 compared to a placebo, both given alongside standard PAH treatments. The goal is to see how safe and effective REGN13335 is for people with PAH.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Placebo Group

Group I: OLE-Arm2Experimental Treatment1 Intervention
Group II: OLE-Arm1Experimental Treatment1 Intervention
Group III: DBTP-Arm2Experimental Treatment1 Intervention
Group IV: DBTP-Arm1Experimental Treatment1 Intervention
Group V: DBTP-Arm3Placebo Group1 Intervention

Find a Clinic Near You

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 profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Citations

REGN13335: Uses, Side Effects, Dosing & 2 Clinical Trials

One such study, NCT07318597, is a Phase 2 trial exploring REGN13335 in adult participants diagnosed with Pulmonary Arterial Hypertension (PAH).

Study of REGN13335 in Adult Participants With Pulmonary ...

The aim of the study is to see how safe and effective REGN13335 is in participants with PAH who are taking other PAH medicines. The study is looking at several ...

THE IMPACT OF THE HUMAN MONOCLONAL ANTIBODY ...

CONCLUSIONS: Neutralizing PDGF-B with REGN13335 reduces PDGF-BB/AB signaling through PDGFR-α and PDGFR-β on vascular support cells and ...

Phase 2 Study of REGN13335 in Adult Participants With ...

The study is focused on participants with Pulmonary Arterial Hypertension (PAH). The aim of the study is to see how safe and effective REGN13335 ...

A study to evaluate the effectiveness and safety ...

REGN13335 is an experimental medicine used to study its effects on people with pulmonary arterial hypertension. It is a type of antibody designed to target and ...