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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

Full criteria on ClinicalTrials.gov

Sites (45)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Prince Charles Hospital
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BrisbaneAustraliaRecruiting
Royal Hobart Hospital
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HobartAustraliaRecruiting
Mater Misericordiae Ltd
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South BrisbaneAustraliaRecruiting
Hopital Erasme
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AnderlechtBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
University Hospital Olomouc
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OlomoucCzechiaNot yet recruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaNot yet recruiting
Institute for Clinical and Experimental Medicine
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PragueCzechiaNot yet recruiting
Justus-Liebig-Universitaet Giessen
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GiessenGermanyRecruiting
Universitaetsmedizin Greifswald KöR
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GreifswaldGermanyRecruiting
Martin-Luther-Universitaet Halle-Wittenberg
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Halle (Saale)GermanyRecruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
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MainzGermanyRecruiting
Krankenhaus Neuwittelsbach
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MunichGermanyRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Costa del Sol
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MarbellaSpainRecruiting
Hospital Universitario De Salamanca
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SalamancaSpainRecruiting
Hospital Universitario Marqués de Valdecilla
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SantanderSpainRecruiting
Hospital Universitario de Toledo
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ToledoSpainRecruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 09FranceNot yet recruiting
Assistance Publique Hopitaux De Paris
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Le Kremlin-BicetreFranceNot yet recruiting
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceNot yet recruiting
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceNot yet recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceNot yet recruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceNot yet recruiting
Royal United Hospitals Bath NHS Foundation Trust
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BathUnited KingdomRecruiting
Imperial College Healthcare Nhs Trust - Hammersmith Hospital
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LondonUnited KingdomRecruiting
Royal Free Hospital
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LondonUnited KingdomRecruiting
Gachon University Gil Medical Center
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Namdong-guSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Severance hospital
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SeoulSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Pauls Stradins Clinical University Hospital
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RigaLatviaRecruiting
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandRecruiting
Centrum Medyczne "Hipokrates" s.c. Elżbieta i Grzegorz Grześk
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BydgoszczPolandRecruiting
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
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CracowPolandRecruiting
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
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KatowicePolandRecruiting
Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
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LodzPolandRecruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandRecruiting
University of Colorado Denver
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AuroraUnited StatesRecruiting
Tufts Medical Center
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BostonUnited StatesRecruiting
University of Cincinnati
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CincinnatiUnited StatesRecruiting
University of Nebraska Medical Center - 2365
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OmahaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.