Clinical trial • Phase II • Cardiology
HUMAN IGG4 KAPPA MONOCLONAL ANTIBODY AGAINST PLATELET-DERIVED GROWTH FACTOR SUBUNIT B for Pulmonary arterial hypertension
Phase II trial of HUMAN IGG4 KAPPA MONOCLONAL ANTIBODY AGAINST PLATELET-DERIVED GROWTH FACTOR SUBUNIT B for Pulmonary arterial hypertension.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Pulmonary arterial hypertension
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 21-11-2025
- First CTIS Authorization Date
- 18-03-2026
Trial design
Randomised, placebo to regn13335 (placebo comparator). background standard of care (soc) therapy on a stable dose and regimen is permitted as described in the protocol. (no dose or schedule for placebo specified in provided data.)-controlled Phase II trial across 30 sites in Belgium, France, Germany and others.
- Randomised
- Yes
- Comparator
- Placebo to REGN13335 (placebo comparator). Background Standard Of Care (SOC) therapy on a stable dose and regimen is permitted as described in the protocol. (No dose or schedule for placebo specified in provided data.)
- Target Sample Size
- 52
Eligibility
Recruits 52 adults.
Inclusion criteria
- {"criterion_text":"- Documented clinical diagnosis of PAH (Group 1 PH according to the 7th World Symposium on Pulmonary Hypertension (WSPH))"}
- {"criterion_text":"- WHO functional class II or III (slight to marked limitation of functional status due to PAH)"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- PVR ≥400 dynes∙sec/cm^5 (5 Wood units) based on Right Heart Catheterization (RHC) during the screening period"}
- {"criterion_text":"- Has 6MWD ≥150 and ≤550 meters repeated twice during screening as described in the protocol"}
- {"criterion_text":"- Note: Other protocol-defined inclusion criteria apply"}
Exclusion criteria
- {"criterion_text":"- 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"}
- {"criterion_text":"- Note: Other protocol-defined exclusion criteria apply"}
- {"criterion_text":"- Pulmonary Arterial Wedge Pressure (PAWP) >15 mm Hg by RHC during the screening period"}
- {"criterion_text":"- History of left-sided heart disease and/or clinically significant cardiac disease, as described in the protocol"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Evidence of interstitial lung disease as defined in the protocol"}
- {"criterion_text":"- Evidence of chronic thromboembolic pulmonary disease or acute pulmonary embolism as described in the protocol"}
- {"criterion_text":"- Participants requiring anticoagulation and/or antiplatelet therapy for an underlying medical condition as described in the protocol"}
- {"criterion_text":"- Has any history of intracranial bleeding or any history of elevated intracranial pressure"}
- {"criterion_text":"- Has any history of bleeding meeting criteria as described in the protocol"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline in Pulmonary Vascular Resistance (PVR)","definition_or_measurement_approach":"Change from baseline in PVR; PVR is assessed based on Right Heart Catheterization (RHC) measurements during screening and follow-up as described in the protocol"}
Secondary endpoints
- {"endpoint_text":"- Occurrence of Treatment-Emergent Adverse Events (TEAEs)","definition_or_measurement_approach":"Standard reporting of treatment-emergent adverse events collected throughout the study period as per protocol safety assessments"}
- {"endpoint_text":"- Severity of TEAEs","definition_or_measurement_approach":"Severity graded according to protocol-specified criteria (e.g., CTCAE or study definitions) as collected in safety assessments"}
- {"endpoint_text":"- Change from baseline in circulating N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) concentrations","definition_or_measurement_approach":"Change from baseline in circulating NT-proBNP measured in plasma samples using validated laboratory assays"}
- {"endpoint_text":"- Change from baseline in mean pulmonary artery pressure","definition_or_measurement_approach":"Change from baseline in mean pulmonary artery pressure assessed by hemodynamic measurements (e.g., RHC) per protocol"}
- {"endpoint_text":"- Change from baseline in cardiac output","definition_or_measurement_approach":"Change from baseline in cardiac output measured by hemodynamic assessments as specified in the protocol"}
- {"endpoint_text":"- Change from baseline in cardiac index","definition_or_measurement_approach":"Change from baseline in cardiac index measured via hemodynamic methods per protocol"}
- {"endpoint_text":"- Change from baseline in right atrial pressure","definition_or_measurement_approach":"Change from baseline in right atrial pressure measured by RHC or protocol-specified hemodynamic assessment"}
- {"endpoint_text":"- Change from baseline in 6-Minute Walk Distance (6MWD)","definition_or_measurement_approach":"Change from baseline in distance walked during standardized 6-minute walk test (6MWD) performed per protocol"}
- {"endpoint_text":"- Concentrations of functional REGN13335 in plasma","definition_or_measurement_approach":"Plasma concentrations of functional REGN13335 measured using validated bioanalytical assays"}
- {"endpoint_text":"- Concentrations of total soluble Platelet-Derived Growth Factor-B (PDGF-B) ligands in plasma","definition_or_measurement_approach":"Plasma concentrations of total soluble PDGF-B ligands measured using validated biomarker assays"}
Recruitment
- Digital Remote Recruitment
- True, recruitment uses digital/remote methods including banner ads, basic website materials, telemedicine support, and eCOA/electronic materials (vendors listed for telemedicine and eCOA)
- Planned Sample Size
- 52
- Recruitment Window Months
- 28
- Consent Approach
- Informed consent is obtained using subject information and informed consent forms (Main ICF and related ICFs). Multiple language versions of ICFs and supporting consent materials are provided (document titles include EN, FR, NL, LV, RU, CZ, DE, PL, ES). A Pregnant Partner ICF and other subject-specific ICFs are included. Consent is obtained from each adult participant; materials and procedures are country-specific as per the 'Recruitment and Informed Consent Procedure' documents.
Methods
- Online banner ads and basic website materials (document titles include 'Banner Ads' and 'Basic Website 5 pg')
- Study brochures and printed recruitment materials ('Study Brochure' documents)
- Site-based recruitment supported by local recruitment and informed consent procedure documents (country-specific 'Recruitment and Informed Consent Procedure' files)
- Telemedicine support for recruitment and participant interactions (Datacubed Health listed with role 'Telemedicine')
- Recruitment and retention materials provided by a vendor (Clariness GmbH responsible for 'Recruitment and Retention Materials')
Geography
- Total Number Of Sites
- 30
- Total Number Of Participants
- 47
Belgium
- Earliest CTIS Part Ii Submission Date
- 25-02-2026
- Latest Decision Or Authorization Date
- 18-03-2026
- Processing Time Days
- 21
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Hopital Erasme
- Department Name
- 056001:Cardiologie
- Principal Investigator Name
- Jean-Luc Vachiery
- Principal Investigator Email
- jean.luc.vachiery@hubruxelles.be
- Contact Person Name
- Jean-Luc Vachiery
- Contact Person Email
- jean.luc.vachiery@hubruxelles.be
- Site Name
- UZ Leuven
- Department Name
- 056002:Pneumologie
- Principal Investigator Name
- Marion Delcroix
- Principal Investigator Email
- marion.delcroix@uzleuven.be
- Contact Person Name
- Marion Delcroix
- Contact Person Email
- marion.delcroix@uzleuven.be
France
- Earliest CTIS Part Ii Submission Date
- 09-03-2026
- Latest Decision Or Authorization Date
- 20-03-2026
- Processing Time Days
- 11
- Number Of Sites
- 6
- Number Of Participants
- 9
Sites
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- 250004:Cardiologie
- Principal Investigator Name
- Helene Bouvaist
- Principal Investigator Email
- hbouvaist@chu-grenoble.fr
- Contact Person Name
- Helene Bouvaist
- Contact Person Email
- hbouvaist@chu-grenoble.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- 250002:Pneumologie
- Principal Investigator Name
- Marianne Riou
- Principal Investigator Email
- marianne.riou@chru-strasbourg.fr
- Contact Person Name
- Marianne Riou
- Contact Person Email
- marianne.riou@chru-strasbourg.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- 250001: Pneumologie
- Principal Investigator Name
- Olivier Sitbon
- Principal Investigator Email
- olivier.sitbon@aphp.fr
- Contact Person Name
- Olivier Sitbon
- Contact Person Email
- olivier.sitbon@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- 250006: Pneumologie
- Principal Investigator Name
- Grégoire Prevot
- Principal Investigator Email
- prevot.g@chu-toulouse.fr
- Contact Person Name
- Grégoire Prevot
- Contact Person Email
- prevot.g@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- 250003:Pneumologie
- Principal Investigator Name
- Arnaud Maurac
- Principal Investigator Email
- arnaud.maurac@chu-bordeaux.fr
- Contact Person Name
- Arnaud Maurac
- Contact Person Email
- arnaud.maurac@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- 250005:Médecine Vasculaire et Thérapeutiques
- Principal Investigator Name
- Laurent Bertoletti
- Principal Investigator Email
- laurent.bertoletti@chu-st-etienne.fr
- Contact Person Name
- Laurent Bertoletti
- Contact Person Email
- laurent.bertoletti@chu-st-etienne.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 10-03-2026
- Latest Decision Or Authorization Date
- 26-03-2026
- Processing Time Days
- 16
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- Universitaetsmedizin Greifswald KöR
- Department Name
- 276001; Zentrum für Innere Medizin, Lungenheilkunde und Infektionskrankheiten
- Principal Investigator Name
- Ralf Ewert
- Principal Investigator Email
- ewert@uni-greifswald.de
- Contact Person Name
- Ralf Ewert
- Contact Person Email
- ewert@uni-greifswald.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- 276006; Hautklinik und Poliklinik
- Principal Investigator Name
- Kai-Helge Schmidt
- Principal Investigator Email
- kai_helge.schmidt@unimedizin-mainz.de
- Contact Person Name
- Kai-Helge Schmidt
- Contact Person Email
- kai_helge.schmidt@unimedizin-mainz.de
- Site Name
- Martin-Luther-Universitaet Halle-Wittenberg
- Department Name
- 276005; Innere Medizin
- Principal Investigator Name
- Stephan Eisenmann
- Principal Investigator Email
- stephan.eisenmann@uk-halle.de
- Contact Person Name
- Stephan Eisenmann
- Contact Person Email
- stephan.eisenmann@uk-halle.de
- Site Name
- Krankenhaus Neuwittelsbach
- Department Name
- 276004; Pulmonology
- Principal Investigator Name
- Hanno Leuchte
- Principal Investigator Email
- prof.leuchte@krankenhaus-neuwittelsbach.de
- Contact Person Name
- Hanno Leuchte
- Contact Person Email
- prof.leuchte@krankenhaus-neuwittelsbach.de
- Site Name
- Justus-Liebig-Universitaet Giessen
- Department Name
- 276003; Medizinische Klinik und Poliklinik II
- Principal Investigator Name
- Ardeschir Hossein Ghofrani
- Principal Investigator Email
- ardeschir.ghofrani@innere.med.uni-giessen.de
- Contact Person Name
- Ardeschir Hossein Ghofrani
- Contact Person Email
- ardeschir.ghofrani@innere.med.uni-giessen.de
Latvia
- Earliest CTIS Part Ii Submission Date
- 02-03-2026
- Latest Decision Or Authorization Date
- 18-03-2026
- Processing Time Days
- 16
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Pauls Stradins Clinical University Hospital
- Department Name
- 428001: Department No.24
- Principal Investigator Name
- Andris Skride
- Principal Investigator Email
- andris.skride@gmail.com
- Contact Person Name
- Andris Skride
- Contact Person Email
- andris.skride@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 23-03-2026
- Latest Decision Or Authorization Date
- 26-03-2026
- Processing Time Days
- 3
- Number Of Sites
- 7
- Number Of Participants
- 9
Sites
- Site Name
- Hospital Costa Del Sol
- Department Name
- 724005; Cardiology
- Principal Investigator Name
- Rafael Bravo Marques
- Principal Investigator Email
- rafabravomarques@gmail.com
- Contact Person Name
- Rafael Bravo Marques
- Contact Person Email
- rafabravomarques@gmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- 724004; Pulmonology
- Principal Investigator Name
- Jose Cifrian Martinez
- Principal Investigator Email
- josemanuel.cifrian@scsalud.es
- Contact Person Name
- Jose Cifrian Martinez
- Contact Person Email
- josemanuel.cifrian@scsalud.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- 724007; Neumología
- Principal Investigator Name
- Isabel Blanco
- Principal Investigator Email
- iblanco2@clinic.cat
- Contact Person Name
- Isabel Blanco
- Contact Person Email
- iblanco2@clinic.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- 724002; Cardiology
- Principal Investigator Name
- Pilar Escribano Subías
- Principal Investigator Email
- pilar.escribano.subias@gmail.com
- Contact Person Name
- Pilar Escribano Subías
- Contact Person Email
- pilar.escribano.subias@gmail.com
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- 724006; Medicina Interna
- Principal Investigator Name
- Sergio Cadenas Menendez
- Principal Investigator Email
- sercam.2007@gmail.com
- Contact Person Name
- Sergio Cadenas Menendez
- Contact Person Email
- sercam.2007@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- 724001; Pneumology
- Principal Investigator Name
- Manuel López Meseguer
- Principal Investigator Email
- manuel.lopez@vallhebron.cat
- Contact Person Name
- Manuel López Meseguer
- Contact Person Email
- manuel.lopez@vallhebron.cat
- Site Name
- Hospital Universitario De Toledo
- Department Name
- 724003; Cardiology
- Principal Investigator Name
- Maria Lazaro Salvador
- Principal Investigator Email
- maria.lasal@gmail.com
- Contact Person Name
- Maria Lazaro Salvador
- Contact Person Email
- maria.lasal@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 20-02-2026
- Latest Decision Or Authorization Date
- 27-03-2026
- Processing Time Days
- 35
- Number Of Sites
- 6
- Number Of Participants
- 12
Sites
- Site Name
- Centrum Medyczne "Hipokrates" S.C. Elżbieta i Grzegorz Grześk
- Department Name
- 616006: Cardiology
- Principal Investigator Name
- Grzegorz Grzesk
- Principal Investigator Email
- grzegorz.grzesk@interia.pl
- Contact Person Name
- Grzegorz Grzesk
- Contact Person Email
- ggrzesk@cm.umk.pl
- Site Name
- Wojewodzki Specjalistyczny Szpital Im Dr Wl Bieganskiego
- Department Name
- 616003: Oddzial Kardiologiczny Klinika Kardiologii Katedry Kardiologii UM w Lodzi
- Principal Investigator Name
- Radoslaw Krecki
- Principal Investigator Email
- rkrecki@gmail.com
- Contact Person Name
- Radoslaw Krecki
- Contact Person Email
- rkrecki@gmail.com
- Site Name
- Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
- Department Name
- 616004: Oddzial Kliniczny Chorob Serca i Naczyn z Pododdzialem Intensywnego Nadzoru Kardiologicznego
- Principal Investigator Name
- Grzegorz Kopec
- Principal Investigator Email
- grzegorzkrakow1@gmail.com
- Contact Person Name
- Grzegorz Kopec
- Contact Person Email
- grzegorzkrakow1@gmail.com
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- 616001: Klinika Kardiologii i Chorob Wewnetrznych z OINK
- Principal Investigator Name
- Karol Kaminski
- Principal Investigator Email
- fizklin@wp.pl
- Contact Person Name
- Karol Kaminski
- Contact Person Email
- fizklin@wp.pl
- Site Name
- Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
- Department Name
- 616005: II Oddzial Kardiologii
- Principal Investigator Name
- Grzegorz Smolka
- Principal Investigator Email
- gsmolka@me.com
- Contact Person Name
- Grzegorz Smolka
- Contact Person Email
- gsmolka@me.com
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- 616002: Ośrodek Wczesnych Faz
- Principal Investigator Name
- Tatiana Mularek-Kubzdela
- Principal Investigator Email
- tatianamularek@wp.pl
- Contact Person Name
- Tatiana Mularek-Kubzdela
- Contact Person Email
- tatianamularek@wp.pl
Czechia
- Earliest CTIS Part Ii Submission Date
- 24-02-2026
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 55
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- University Hospital Olomouc
- Department Name
- 203003:III. Interni klinika
- Principal Investigator Name
- Jan Precek
- Principal Investigator Email
- jan.precek@seznam.cz
- Contact Person Name
- Jan Precek
- Contact Person Email
- jan.precek@seznam.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- 203002:II. Interni klinika
- Principal Investigator Name
- Pavel Jansa
- Principal Investigator Email
- pavel.jansa@vfn.cz
- Contact Person Name
- Pavel Jansa
- Contact Person Email
- pavel.jansa@vfn.cz
- Site Name
- Institute For Clinical And Experimental Medicine
- Department Name
- 203001:Klinika kardiologie
- Principal Investigator Name
- Hikmet Al-Hiti
- Principal Investigator Email
- hial@medicon.cz
- Contact Person Name
- Hikmet Al-Hiti
- Contact Person Email
- hial@medicon.cz
Sponsor
Primary sponsor
- Full Name
- Regeneron Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- CRO
Third parties
- {"country":"Slovakia","full_name":"SanaClis s.r.o.","duties_or_roles":"Drug Distribution","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cardiovascular Clinical Sciences Inc.","duties_or_roles":"Central Reading (RHC) & Clinical Event Adjudication","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Datacubed Health Inc.","duties_or_roles":"Telemedicine","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Poland","full_name":"Medicover Integrated Clinical Services Sp. z o.o.","duties_or_roles":"Specialty Lab","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"Translations","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Mapi Research Trust","duties_or_roles":"Translations - PAH SYMPACT","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Central Lab","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"IDMC Vendor","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Simpleshow USA Corp.","duties_or_roles":"OLE IP preparation and administration training video","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Clariness GmbH","duties_or_roles":"Recruitment and Retention Materials","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging - ECHO","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- REGN13335
- Active Substance
- HUMAN IGG4 KAPPA MONOCLONAL ANTIBODY AGAINST PLATELET-DERIVED GROWTH FACTOR SUBUNIT B
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS/SUBCUTANEOUS/INTRAMUSCULAR
- Route
- INTRAVENOUS/SUBCUTANEOUS/INTRAMUSCULAR
- Investigational Product Name
- Placebo to REGN13335
- Modality
- Other
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