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Clinical Trials in the UK / NCT07318597
Recruiting Phase 2

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

NCT07318597 · tracked via the Priya Life Science UK tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 2
Started
2026-05-06
Last updated
2026-09-15

Condition(s) studied

Pulmonary Arterial Hypertension (PAH)

Investigational drug(s) / intervention(s)

REGN13335Placebo

REGN13335: Administered per the protocol

Placebo: Administered per the protocol

Study 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
University of Colorado Denver Aurora Colorado Recruiting
Tufts Medical Center Boston Massachusetts Recruiting
University of Nebraska Medical Center - 2365 Omaha Nebraska Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
Mater Misericordiae Ltd South Brisbane Queensland Recruiting
Royal Hobart Hospital Hobart Tasmania Recruiting
UZ Leuven Leuven Vlaams-Brabant Recruiting
H.U.B. Erasme Hospital Brussels Belgium Recruiting
Hopital Bicetre Le Kremlin-Bicêtre France Recruiting
Nouvel hopital civil Strasbourg France Recruiting
Universitatsklinikum Halle Halle Saxony-Anhalt Recruiting
Clinic of University Greifswald Greifswald Germany Recruiting
Universitatsmedizin Mainz Mainz Germany Recruiting
P. Stradins Clinical University hospital Riga Latvia Recruiting
University Clinical Hospital in Poznan - Early Phase Unit Poznan Greater Poland Voivodeship Recruiting
University Hospital in Bialystok Bialystok Podlaskie Voivodeship Recruiting
Oddzial Kardiologiczny Lodz Łódź Voivodeship Recruiting
Gachon University Gil Medical Center Namdong-gu Incheon Recruiting
Asan Medical Center Seoul Songpa-gu Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Severance Hospital Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Hospital Vall d'Hebron Barcelona Catalonia Recruiting
Hospital Universitario Costa del Sol Marbella Malaga Recruiting
Hospital Clinic, Barcelona Barcelona Spain Recruiting
University hospital 12 de octubre Madrid Spain Recruiting
University Hospital Salamanca Salamanca Spain Recruiting
Hospital Universitario De Toledo Toledo Spain Recruiting
Royal United Hospitals Bath NHS Foundation Trust Bath United Kingdom Recruiting
Imperial College Healthcare NHS Trust, Hammersmith Hospital London United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07318597 on ClinicalTrials.gov ↗ ← All trials in the UK