NCT07318597RecruitingPhase 2
Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamic Effects of REGN13335, an Anti-PDGF-B Monoclonal Antibody, in Adults With Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 99 (estimated)
- First submitted
- 2 Jan 2026
- Start date
- 6 May 2026
- Primary completion date
- 27 Feb 2028
- Lead sponsor
- Regeneron Pharmaceuticals
- NCT number
- NCT07318597
- EU CT number
- 2024-514754-79-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 99
- From 6 May 2026 to the primary completion date, 27 Feb 2028
- 45 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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
Other
- Pulmonary Arterial Wedge Pressure (PAWP) \>15 mm Hg by RHC during the screening period
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (45)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Prince Charles Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Recruiting |
| Royal Hobart Hospital Coordinator of this site? Confirm its status | Hobart | Australia | Recruiting |
| Mater Misericordiae Ltd Coordinator of this site? Confirm its status | South Brisbane | Australia | Recruiting |
| Hopital Erasme Coordinator of this site? Confirm its status | Anderlecht | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Not yet recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| Institute for Clinical and Experimental Medicine Coordinator of this site? Confirm its status | Prague | Czechia | Not yet recruiting |
| Justus-Liebig-Universitaet Giessen Coordinator of this site? Confirm its status | Giessen | Germany | Recruiting |
| Universitaetsmedizin Greifswald KöR Coordinator of this site? Confirm its status | Greifswald | Germany | Recruiting |
| Martin-Luther-Universitaet Halle-Wittenberg Coordinator of this site? Confirm its status | Halle (Saale) | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
| Krankenhaus Neuwittelsbach Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Costa del Sol Coordinator of this site? Confirm its status | Marbella | Spain | Recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Recruiting |
| Hospital Universitario de Toledo Coordinator of this site? Confirm its status | Toledo | Spain | Recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 09 | France | Not yet recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Le Kremlin-Bicetre | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Not yet recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
| Royal United Hospitals Bath NHS Foundation Trust Coordinator of this site? Confirm its status | Bath | United Kingdom | Recruiting |
| Imperial College Healthcare Nhs Trust - Hammersmith Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Free Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Namdong-gu | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Pauls Stradins Clinical University Hospital Coordinator of this site? Confirm its status | Riga | Latvia | Recruiting |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Recruiting |
| Centrum Medyczne "Hipokrates" s.c. Elżbieta i Grzegorz Grześk Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego Coordinator of this site? Confirm its status | Lodz | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
| University of Colorado Denver Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Tufts Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| University of Nebraska Medical Center - 2365 Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.