RightFit
RecruitingPhase 2

Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN13335, an Anti-PDGF-B Monoclonal Antibody, in Adults With Pulmonary Arterial Hypertension

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests REGN13335, an experimental drug, in adults with pulmonary arterial hypertension (PAH), or high blood pressure in the arteries of the lungs. It will check how safe the drug is and how well it works in people already taking other PAH medicines.

This study is researching an experimental drug called REGN13335. The study is focused on participants with Pulmonary Arterial Hypertension (PAH). 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 other research questions, including: * What side effects may happen from taking REGN13335 * How much REGN13335 is in the blood at different times * Whether the body makes antibodies against REGN13335 (which could make REGN13335 less effective or could lead to side effects)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of Group 1 PAH.
  • Have PAH that slightly or greatly limits physical activity (WHO class II or III).
  • Take standard PAH medicines at stable doses, as judged by the study doctor.
  • Have resistance to blood flow in the lungs of at least 5 Wood units. This is measured during screening with a thin tube placed in the heart.
  • Walk 150 to 550 meters in 6 minutes on each of two screening tests.

Who can't join

  • Have high blood pressure in the lungs from heart disease, lung disease, low oxygen, blocked lung arteries, or unclear or multiple causes (Groups 2–5).
  • Have a pulmonary artery wedge pressure above 15 mm Hg during screening. This pressure is measured with a thin tube placed in the heart.
  • Have a history of left-sided heart disease or other significant heart disease, as defined by the study.
  • Have lung disease that blocks airflow and meets the study’s breathing-test limits, or signs of interstitial lung disease, which affects tissue around the lung’s air sacs.
  • Have signs of long-term disease from blood clots in the lungs or a new blood clot in the lungs.
  • Need blood-thinning or clot-preventing medicines for another medical condition, as defined by the study.
  • Have ever had bleeding inside the skull or high pressure inside the skull.
  • Have a history of bleeding that meets the study’s rules. Other study rules for joining or being excluded also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: 1. Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH)) 2. WHO functional class II or III (slight to marked limitation of functional status due to PAH) 3. Receiving background Standard Of Care (SOC) therapy for PAH on a stable dose and regimen, as determined by the investigator, as described in the protocol 4. PVR ≥400 dynes∙sec/cm\^5 (5 Wood units) based on Right Heart Catheterization (RHC) during the screening period 5. Has 6MWD ≥150 and ≤550 meters repeated twice during screening as described in the protocol Key Exclusion Criteria: 1. Has Group 2 (PH associated with left heart disease), Group 3 (PH associated with lung diseases and/or hypoxia), Group 4 (PH associated with pulmonary artery obstructions), or Group 5 (PH with unclear and/or multifactorial mechanisms) PH according to the 7th WSPH 2. Pulmonary Arterial Wedge Pressure (PAWP) \>15 mm Hg by RHC during the screening period 3. History of left-sided heart disease and/or clinically significant cardiac disease, as described in the protocol 4. Obstructive lung disease defined as Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity \<0.7 and FEV1 \<70% of the predicted value as described in the protocol 5. Evidence of interstitial lung disease as defined in the protocol 6. Evidence of chronic thromboembolic pulmonary disease or acute pulmonary embolism as described in the protocol 7. Participants requiring anticoagulation and/or antiplatelet therapy for an underlying medical condition as described in the protocol 8. Has any history of intracranial bleeding or any history of elevated intracranial pressure 9. Has any history of bleeding meeting criteria as described in the protocol Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Study sites (4)

CO

MA

NE

OH