Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

390

Participants

Timeline

Start Date

December 28, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

December 31, 2025

Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG

Placebo

Matching capsule containing placebo

DRUG

Seralutinib

Capsule containing seralutinib

DEVICE

Generic Dry Powder Inhaler

Generic dry powder inhaler for seralutinib or placebo delivery

Trial Locations (189)

3065

St Vincent's Hospital, Melbourne

10016

NYU Langone Health, New York

14642

University of Rochester Medical Center, Rochester

15212

Allegheny General Hospital, Pittsburgh

15213

UPMC Presbyterian Hospital, Pittsburgh

19104

The Hospital of the University of Pennsylvania, Philadelphia

19140

Temple Heart and Vascular Institute (Outpatient Clinic), Philadelphia

20037

The George Washington University Medical Faculty Associates, Washington D.C.

21201

University of Maryland Medical Center, Baltimore

22042

Inova Fairfax Medical Campus, Falls Church

23230

Pulmonary Associates of Richmond, Inc., Richmond

27514

UNC Hospitals, Chapel Hill

27710

Duke University Medical Center - Duke South, Durham

29425

Medical University of South Carolina - Nexus Research Center, Charleston

30309

Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead, Atlanta

30322

Emory University, Atlanta

30342

Northside Hospital Laboratory - Atlanta, Atlanta

32224

Mayo Clinic, Jacksonville

32610

University of Florida Clinical Research Center, Gainesville

35233

University of Alabama at Birmingham, Birmingham

40202

Norton Hospital, Louisville

43210

The Ohio State University Wexner Medical Center, Columbus

44195

Cleveland Clinic Foundation, Cleveland

45219

University of Cincinnati Medical Center, Cincinnati

48109

University of Michigan, Ann Arbor

52242

University of Iowa Hospitals & Clinics, Iowa City

53215

Advocate Aurora Health-Aurora St. Luke's Medical Center, Milwaukee

53226

Froedtert Hospital/Medical College of Wisconsin, Milwaukee

55455

M Health Fairview University of Minnesota Medical Center - East Bank, Minneapolis

55905

Mayo Clinic, Rochester

60611

Northwestern Memorial Hospital, Clinical Research Unit, Chicago

60612

UI Health Hospital, Chicago

63110

Washington University School of Medicine, St Louis

65212

University of Missouri, Columbia

66160

University of Kansas Medical Center, Kansas City

68198

University of Nebraska Medical Center, Omaha

70121

Ochsner Medical Center, New Orleans

73112

INTEGRIS Cardiovascular Physicians, LLC, Oklahoma City

75024

Baylor Scott & White Medical Center - The Heart Hospital, Plano

75246

Baylor University Medical Center, Dallas

75390

UT Southwestern Medical Center, Dallas

77030

CHI St. Luke's Health Baylor College of Medicine Medical Center, Houston

Houston Methodist Outpatient Center, Houston

78229

University of Texas Health Science Center at San Antonio, San Antonio

80445

University of Colorado Hospital, Aurora

84107

Intermountain Medical Center, Murray

84132

University of Utah Hospital, Salt Lake City

87131

University of New Mexico Health Sciences Center, Albuquerque

90033

Keck Medical Center of USC, Los Angeles

90073

Dept of Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles

92037

UC San Diego Medical Center (La Jolla), La Jolla

92868

University of California, Irvine Medical Center, Orange

93105

Medical Corporation, Santa Barbara

93711

Valley Advanced Lung Diseases Institute, Fresno

94305

Stanford Healthcare, Stanford

95817

UC Davis Health, Sacramento

97239

Oregon Health & Science University, Portland

3436212

Lady Davis Carmel Medical Center, Haifa

4428164

Meir Medical Center, Kfar Saba

7500587

Enroll SpA, Santiago

06030

UConn Health/Clinical Research Center, Farmington

06519

Winchester Center for Lung Disease, New Haven

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

02903

Rhode Island Hospital, Providence

Unknown

Cardiologia Palermo, Buenos Aires

Instituto Cardiovascular de Buenos Aires, Buenos Aires

Instituto de Cardiologia de Corrientes Juana Francisca Cabral, Corrientes

Hospital Privado Centro Medico de Cordóba S.A., Córdoba

Instituto de Investigaciones Clinicas Quilmes, Quilmes

Instituto Medico Rio Cuarto, Río Cuarto

Sanatorio Parque S.A., Rosario

Hospital Provincial Dr. José María Cullen, Santa Fe

Macquarie University, North Ryde

Wesley Research Institute, Auchenflower

Royal Hobart Hospital, Hobart

Nepean Hospital, Kingswood

Religious Hospital Linz GmbH, Linz

AKH-Vienna Medical Univesity of Vienna Internal Medicine II-Cardiology, Vienna

Hôpital Erasme, Anderlecht

University Hospitals of Leuven (Campus Gasthuisberg), Leuven

Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa, Belo Horizonte

Complexo de Prevencao, Diagnostico, Terapia e Reabilitacao Respiratoria - Hospital Dia do Pulmao, Blumenau

Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre

Uniao Brasileira de Educaçao e Assistência Hospital São Lucas da PUCRS, Porto Alegre

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo

Núcleo de Gestão de Pesquisa/Hospital São Paulo - SPDM/UNIFESP, São Paulo

Peter Lougheed Center, Calgary

University Health Network, Toronto

Centro de Investigacion Clinica UC-CICUC, Santiago

Fundación Abood Shaio, Bogotá

Fundación Neumologica Colombiana, Bogotá

Institut Klinicke a Experimentalni Mediciny, Prague

Všeobecná fakultní nemocnice v Praze Il. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hypertenzi, Prague

Aarhus Universitetshospital, Department of Cardiology, Aarhus

Rigshospitalet, Department of Cardiology, Copenhagen

CHU Bicêtre, Le Kremlin-Bicêtre

Institut Coeur Poumon, Lille

CHU de Montpellier, Montpellier

Hôpital Pasteur, Nice

CHU de Poitiers, Poitiers

Hôpitaux Universitaires de Strasbourg, Strasbourg

Centre Hospitalier Universitaire - Hôpital d´Adultes de Brabois, Vandœuvre-lès-Nancy

DRK Kliniken Berlin Westend, Berlin

Zentrum fur Pulmona le Hypertonie, Klini k Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternlstische lntensiv medizin), Herzzentrum der Universitat zu Koln, Cologne

Universitatsklinikum Dresden, Medizinische Klinik / Pneumologisches Studiensekretariat, Dresden

Universitatsklinikum Giessen und Marburg GmbH Zentrum fur Innere Medizin, Med. Klinik und Poliklinik II Studienambulanz fur Pulmonale Hypertonie, Giessen

Universitätsklinikum Greifswald Klinik und Poliklinik für Innere Medizin B, Greifswald

Universitätsklinikum Halle (Saale) / Martin-Luther-Universität Halle- Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I, Halle

Universitätsklinikum Hamburg-Eppendorf Zentrum für Onkologie Studienzentrum Pneumologie, Hamburg

Medizinische Hochschule Hannover Klinik für Pneumologie und Infektiologie, Hanover

Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie, Heidelberg

Universitätsklinikum des Saarlandes, Innere Medizin V - Pneumologie, Allergologie, Beatmungs- und Umweltmedizin, Homburg

Krankenhaus Neuwittelsbach, Munich

Klinikum der LMU Medizinische Klinik und Poliklinik V, München

Klinikum Wurzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin, Würzburg

"Evangelismos General Hospital, 1st Department of Clinical Care & Pulmonary Hypertension Clinic", Athens

ATTIKON University Hospital, 2nd Critical Care Department, Athens

Onassis Cardiac Surgery Center, Kallithea

AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic, Thessaloniki

Mater Misericordiae University Hospital, Respiratory Department, Dublin

Rabin Medical Center, Petah Tikva

The Chaim Sheba Medical Center, Ramat Gan

Tel Aviv Sourasky Medical Center, Tel Aviv

IRCCS Azienda Ospedaliero Universitaria Di Bologna Policlinico 5 Orsola Malpighi - U.O.C. Cardiologia, Bologna

IRCCS Ospedale Policlinico San Martino - Cardiovascular Diseases Unit - Cardiac, Thoracic and Vascular Department, Genova

Azienda Ospedaliera Dei Colli - Ospedale Monaldi Centro per la Diagnosi e Terapia dell'Ipertensione Polmonare, Napoli

Fondazione IRCCS Policlinico San Matteo - U.O. di Cardiologia, Pavia

Azienda Ospealiero Universitaria Policlinico Umberto I - Dipartamento di Scienze Cliniche Internistiche Anestesiologiche e Cardiovascolari - VIII Padglione, Rome

Azienda Sanitaria Universitaria Giuliano Isontina /ASUGI - Ospedale di Cattinara - Cardiovascular Department Coronary Intensive Care Unit, Trieste

Kyushu University Hospital, Fukuoka

Kurume University Hospital, Kurume

Nagoya University Hospital, Nagoya

NHO Okayama Medical Center, Okayama

Keio University Hospital, Shinjuku-Ku

National Cerebral and Cardiovascular Center, Suita

Kyorin University Hospital, Tokyo

University of Tokyo Hospital, Tokyo

Pauls Stradins Clinical University Hospital, Riga

Hospital of Lithuanian University of Health Sciences Kauno klinikos, Kaunas

Instituto nacional de Cardiologia Ignacio Chavez, Mexico City

Hospital Universitario Dr. José Eleuterio González Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas, Monterrey

Unidad de Investigacion Clinica en Medicina, S.C., Monterrey

Amsterdam UMC, location VUmc, Amsterdam

Erasmus MC, Rotterdam

Krakowski Szpital Specjalistyczny Im. Św. Jana Pawła II Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Krakow

Europejskie Centrum Zdrowia Otwock Sp. z o.o. Szpital irn. Fryderyka Chopina Oddzial Kardiologiczny, Otwock

Centro Hospitalar e Universitário de Coimbra, Coimbra

Centro Hospitalar Universitário Lisboa Norte, EPE - Hospital Pulido Valente, Lisbon

Centro Hospitalar Universitário de Santo António, Porto

Centro Hospitalar Vila Nova De Gaia, Vila Nova de Gaia

CardioPulmonary Research Center, Guaynabo

"Emergency Institute of Cardiovascular Diseases Prof. Dr. C.C. Iliescu Bucharest, Cardiology 2", Bucharest

"Niculae Stanciolu Emergency Heart Institute for Cardivascular Diseases", Cluj-Napoca

Mediprax Centrum S.R.L, Cluj-Napoca

Targu-Mures Emergency Clinical County Hospital, Internal Medicine II, Târgu Mureş

King Fahad Medical City, Riyadh

King Faisal Specialist Hospital and Research Center, Riyadh

"Institute for Cardiovascular Diseases Dedinje Clinic for Cardiology", Belgrade

University Clinical Centre of Serbia, Cardiology Clinic, Belgrade

National Heart Centre Singapore, Singapore

National University Heart Centre Singapore, Singapore

Gachon University Gil Medical Center, Incheon

Asan Medical Center, Seoul

Samsung Medical Center, Seoul

Seoul National University Hospital, Seoul

Severance Hospital, Yonsei University Health System Seoul, Seoul

The Catholic University of Korea, Seoul St. Mary´s Hospital, Seoul

Hospital Clinic I Provincial, Barcelona

Hospital Universitari Vall d'Hebron, Barcelona

Hospital Universitario 12 De Octubre, Madrid

Hospital Universitario Puerta De Hierro Majadahonda, Majadahonda

Hospital Costa del Sol, Marbella

Hospital Universitario Son Espases, Palma de Mallorca

Hospital Universitario de Salamanca (Complejo Asistencial Universitario De Salamanca), Salamanca

Hospital Universitario Marques de Valdecilla, Santander

Hospital Universitario Virgen del Rocío, Seville

Hospital Universitario de Toledo, Toledo

Hospital universitario Y Politecnico La Fe, Valencia

Royal Papworth Hospital NHS Foundation Trust, Cambridge

Golden Jubilee National Hospital, Agamemnon Street, Clydebank

Hammersmith Hospital, London

Royal Brompton Hospital, Pulmonary Hypertension Service, Sydney Street, London

Royal Free Hospital, London

Freeman Hospital, Newcastle

Sheffield Clinical Research Facility, Royal Hallamshire Hospital, Sheffield

N6A 5W9

London Health Science Centre - Victoria Hospital, London

K1Y4W7

University of Ottawa Heart Institute, Ottawa

All Listed Sponsors
lead

GB002, Inc.

INDUSTRY

NCT05934526 - Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA) | Biotech Hunter | Biotech Hunter