At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- REGN13335 (drug), Placebo (drug)
- How long the study runs
- Study runs about 28 months (dates as stated)
- About the drug or intervention
- REGN13335 — drug: Administered per the protocol · Placebo — drug: Administered per the protocol
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 99
- Started
- 2026-05-06
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for pulmonary arterial hypertension (pah)
- • Phase2 - 99 participants
- • This study is researching an experimental drug called REGN13335
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with pulmonary arterial hypertension (pah)
Where?
- • Bath - Royal United Hospitals Bath NHS Foundation Trust
- • London - Royal Free Hospital
- • London - Imperial College Healthcare NHS Trust, Hammersmith Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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)
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on lung Hypertension (WSPH))
- ✓WHO functional class II or III (slight to marked limitation of functional status due to PAH)
- ✓Receiving background the usual treatment (SOC) therapy for PAH on a stable dose and regimen, as determined by the...
- ✓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
Who cannot take part
- ✗lung Arterial Wedge Pressure (PAWP) \>15 mm Hg by RHC during the screening period
- ✗History of left-sided heart disease and/or clinically significant heart 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...
- ✗Evidence of interstitial lung disease as defined in the protocol
- ✗Evidence of chronic thromboembolic lung disease or acute lung embolism as described in the protocol
See the full criteria
Where Is This Study? (3 UK sites)
Royal United Hospitals Bath NHS Foundation Trust
Bath BA1 3NG, United Kingdom
Royal Free Hospital
London NW3 2QG, United Kingdom
Imperial College Healthcare NHS Trust, Hammersmith Hospital
London W12 0HS, United Kingdom
How to Get in Touch
Clinical Trials Administrator
Sponsor contactCONTACT
