Actively Recruiting
Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)
Led by Regeneron Pharmaceuticals · Updated on 2026-04-28
99
Participants Needed
3
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented clinical diagnosis of Pulmonary Arterial Hypertension (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension)
- WHO functional class II or III (slight to marked limitation of functional status due to PAH)
- Receiving stable background Standard Of Care therapy for PAH as determined by the investigator
- Pulmonary Vascular Resistance (PVR) greater than or equal to 400 dynes·sec/cm^5 (5 Wood units) based on Right Heart Catheterization during screening
- Six-minute walk distance between 150 and 550 meters repeated twice during screening as per protocol
You will not qualify if you...
- Group 2, 3, 4, or 5 pulmonary hypertension as defined by the 7th World Symposium on Pulmonary Hypertension
- Pulmonary Arterial Wedge Pressure greater than 15 mm Hg by Right Heart Catheterization during screening
- History of left-sided heart disease or clinically significant cardiac disease
- Obstructive lung disease defined as FEV1/FVC less than 0.7 and FEV1 less than 70% of predicted
- Evidence of interstitial lung disease
- Evidence of chronic thromboembolic pulmonary disease or acute pulmonary embolism
- Requirement for anticoagulation or antiplatelet therapy for an underlying condition
- History of intracranial bleeding or elevated intracranial pressure
- History of bleeding as defined in the protocol
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
3
Imperial College Healthcare NHS Trust, Hammersmith Hospital
London, United Kingdom, W12 0HS
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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