RecruitingPhase 3NCT06274801

Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)

An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)

Sponsor

Gossamer Bio USA, Inc.

Enrollment

330 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

Pulmonary Arterial Hypertension

Summary

This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Gereic Dry Powder Inhaler and a drug called Seralutinib for people with pulmonary arterial hypertension. The study is currently recruiting participants at 120 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSeralutinib

Capsule containing seralutinib

DEVICEGereic Dry Powder Inhaler

Generic dry powder inhaler for seralutinib delivery

Locations(120)

Valley Advanced Lung Diseases Institute

Fresno, California, United States

Department of Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, United States

UC Davis Health Medical Center

Sacramento, California, United States

Stanford Healthcare

Stanford, California, United States

University of Florida Health

Gainesville, Florida, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead

Atlanta, Georgia, United States

The Emory Clinic

Atlanta, Georgia, United States

Northside Hospital - Atlanta

Atlanta, Georgia, United States

UI Health Hospital

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Norton Pulmonary Specialists

Louisville, Kentucky, United States

University of Michigan

Ann Arbor, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

NYU Langone Health

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

UNC Hospitals

Chapel Hill, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

INTEGRIS Cardiovascular Physicians

Oklahoma City, Oklahoma, United States

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Temple Heart and Vascular Institute (Outpatient Clinic)

Philadelphia, Pennsylvania, United States

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina - Nexus Research Center

Charleston, South Carolina, United States

UT Southwestern Medical Center

Dallas, Texas, United States

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

Houston, Texas, United States

Houston Methodist Outpatient Center

Houston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Utah Hospital

Salt Lake City, Utah, United States

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, United States

Cardiologia Palermo

Buenos Aires, Argentina

Instituto de Cardiologia de Corrientes Juana Francisca Cabral

Corrientes, Argentina

Instuto de Investigacion Clinicas Quilmes

Quilmes, Argentina

Instituto Medico Rio Cuarto

Río Cuarto, Argentina

Hospital Provincial Dr. Jose Maria Cullen

Santa Fe, Argentina

Pulmonary Hypertension Research Queensland

Auchenflower, Australia

St Vincent's Hospital (Melbourne)

Fitzroy, Australia

Royal Hobart Hospital

Hobart, Australia

Hopital Erasme

Anderlecht, Belgium

University Hospitals of Leuven (Campus Gasthuisberg)

Leuven, Belgium

Instituto das Pequenas Missionarias de Maria Imaculada - Hospital Madre Teresa

Belo Horizonte, Brazil

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

Blumenau, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil

Instituto do Coracao do Hospital das Clinicas da Faculdade de medicina da Universidade de Sao Paulo

São Paulo, Brazil

Nucleo de Gestao de Pesquisa/Hospital Sao Paulo - SPDM/UNIFESP

São Paulo, Brazil

Peter Lougheed Center

Calgary, Canada

London Health Sciences Centre - Victoria Hospital

London, Canada

University of Ottawa Heart Institute

Ottawa, Canada

University Health Network, Toronto General Hospital

Toronto, Canada

Centro de Investigacion Clinica UC-CICUC

Santiago, Chile

Enroll SpA

Santiago, Chile

Fundacion Abood Shaio

Bogotá, Colombia

Fundacion Neumologica Colombiana

Bogotá, Colombia

Institut klinicke a experimentalni mediciny Klinika kardiologie Ambulance plicni hypertenze

Prague, Czechia

Všeobecná fakultní nemocnice v Praze ll. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hvpertenzi

Prague, Czechia

Aarhus Universiteshospital

Aarhus, Denmark

CHU Bicetre, Service de Pneumologie et Reanimation Respiratorie

Le Kremlin-Bicêtre, France

Centre Hospitalier REgional Universitaire de Lille Hopital Cardiologique - Institut Coeur Poumon Service de Cardiologie

Lille, France

CHU de Nice - Hopital Pasteur

Nice, France

CHU de Poitiers

Poitiers, France

Zentrum fur Pulmonale Hypertonie, Klinik Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternistische lntensivmedizin), Herzzentrum der Universitat zu Koln

Cologne, Germany

Universitätsklinikum Dresden, Medizinische Klinik I / Pneumologisches Studiensekretariat

Dresden, Germany

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

Giessen, Germany

Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie

Heidelberg, Germany

Klinikum der LMU Medizinische Klinik und Poliklinik V

Munich, Germany

Krankenhaus Neuwittelsbach

München, Germany

Klinikum Würzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin

Würzburg, Germany

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

Athens, Greece

ATTIKON University Hospital, 2nd Critical Care Department

Athens, Greece

Onassis Cardiac Surgery Center, Non-Invasive Cardiology Department

Kallithea, Greece

AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic

Thessaloniki, Greece

Mater Misericordiae University Hospital

Dublin, Ireland

Lady Davis Carmel Medical Center

Haifa, Israel

IRCCS Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - UOC Cardiologia

Bologna, Italy

Azienda Ospedaliera Dei Colli - Ospedale Monaldi

Naples, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

A.O.U. Policlinico Umberto I

Roma, Italy

University of Tokyo Hospital

Bunkyō City, Japan

Kyushu University Hospital

Fukuoka, Japan

Kyorin University Hospital

Mitaka, Japan

Nagoya University Hospital

Nagoya, Japan

NHO Okayama Medical Center

Okayama, Japan

Keio University Hospital

Shinjuku-Ku, Japan

National Cerebral and Cardiovascular Center

Suita, Japan

Pauls Stradins Clinical University Hospital

Riga, Latvia

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, Lithuania

Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, Mexico

Unidad de Investigacion Clinica en Medicina, S.C.

Monterrey, Mexico

Amsterdam UMC, location VU mc

Amsterdam, Netherlands

Erasmus MC

Rotterdam, Netherlands

Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn z Pododdzialem Intensywnego Nadzoru Kardiologicznego

Krakow, Poland

Europejskie Centrum Zdrowia Otwock Sp.zo.o. Szpital im. Fryderyka Chopina Oddzial Kardiologiczny

Otwock, Poland

Unidade Local de Saude de Santa Maria, E.P.E. Hospital Pulido Valente

Lisbon, Portugal

Unidade Local de Saude de Santo Antonio, E.P.E. Hospital de Santo Antonio

Porto, Portugal

Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Cardiology 2

Bucharest, Romania

"Niculae Stancioiu" Emergency Heart Institute for Cardiovascular Diseases, Cardiology 1 Department

Cluj-Napoca, Romania

King Fahad Medical City

Riyadh, Saudi Arabia

King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia

University Clinical Centre of Serbia, Cardiology Clinic

Belgrade, Serbia

National Heart Centre Singapore

Singapore, Singapore

National University Heart Centre

Singapore, Singapore

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Hospital Clinic I Provincial

Barcelona, Spain

Hospital Universitario 12 De Octubre

Madrid, Spain

Hospital Universitario Marques de Valdecilla

Santander, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Universitario de Toledo

Toledo, Spain

Royal Papworth Hospital NHS Foundation Trust

Cambridge, United Kingdom

Golden Jubilee National Hospital

Clydebank, United Kingdom

Hammersmith Hospital

London, United Kingdom

Royal Free Hospital, Clinical Research Facility

London, United Kingdom

Freeman Hospital

Newcastle, United Kingdom

Royal Hallamshire Hospital

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06274801

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