Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH) (NCT07318597) | Clinical Trial Compass
RecruitingPhase 2
Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)
United States, Australia, France99 participantsStarted 2026-05-06
Plain-language summary
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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH))
. WHO functional class II or III (slight to marked limitation of functional status due to PAH)
. 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
. PVR ≥400 dynes∙sec/cm\^5 (5 Wood units) based on Right Heart Catheterization (RHC) during the screening period
. Has 6MWD ≥150 and ≤550 meters repeated twice during screening as described in the protocol
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in Pulmonary Vascular Resistance (PVR)
. 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
. Pulmonary Arterial Wedge Pressure (PAWP) \>15 mm Hg by RHC during the screening period
. History of left-sided heart disease and/or clinically significant cardiac disease, as described in the protocol
. 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
. Evidence of interstitial lung disease as defined in the protocol
. Evidence of chronic thromboembolic pulmonary disease or acute pulmonary embolism as described in the protocol
. Participants requiring anticoagulation and/or antiplatelet therapy for an underlying medical condition as described in the protocol
. Has any history of intracranial bleeding or any history of elevated intracranial pressure