Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)
Recruiting · NCT07318597 · Interventional (participants receive a specific treatment) · Lead sponsor: Regeneron Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboREGN13335
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)
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
- Key
Exclusion criteria
- 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
- Has any history of bleeding meeting criteria as described in the protocol
- Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Where it is running
27 locations listed across 2 US states.
- University of Colorado Denver - Aurora, Colorado, United States
- Tufts Medical Center - Boston, Massachusetts, United States
- Hospital Clinic, Barcelona - Barcelona, Spain
- Royal United Hospitals Bath NHS Foundation Trust - Bath, United Kingdom
- H.U.B. Erasme Hospital - Brussels, Belgium
- Clinic of University Greifswald - Greifswald, Germany
- Hopital Bicetre - Le Kremlin-Bicêtre, France
- Imperial College Healthcare NHS Trust, Hammersmith Hospital - London, United Kingdom
- University hospital 12 de octubre - Madrid, Spain
- Universitatsmedizin Mainz - Mainz, Germany
- P. Stradins Clinical University hospital - Riga, Latvia
- University Hospital Salamanca - Salamanca, Spain
- Seoul National University Hospital - Seoul, South Korea
- Severance Hospital - Seoul, South Korea
- Samsung Medical Center - Seoul, South Korea
- Hospital Universitario De Toledo - Toledo, Spain
- Hospital Vall d'Hebron - Barcelona, Catalonia, Spain
- University Clinical Hospital in Poznan - Early Phase Unit - Poznan, Greater Poland Voivodeship, Poland
- Gachon University Gil Medical Center - Namdong-gu, Incheon, South Korea
- Hospital Universitario Costa del Sol - Marbella, Malaga, Spain
- University Hospital in Bialystok - Bialystok, Podlaskie Voivodeship, Poland
- Mater Misericordiae Ltd - South Brisbane, Queensland, Australia
- Universitatsklinikum Halle - Halle, Saxony-Anhalt, Germany
- Asan Medical Center - Seoul, Songpa-gu, South Korea
- Royal Hobart Hospital - Hobart, Tasmania, Australia
- UZ Leuven - Leuven, Vlaams-Brabant, Belgium
- Oddzial Kardiologiczny - Lodz, Łódź Voivodeship, Poland