RecruitingRecruiting
Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
NCT06274801 · Gossamer Bio USA, Inc.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)
About this study
The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.
Eligibility criteria
Inclusion Criteria:
1. Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.
2. Evidence of an informed consent document, signed and dated by the subject, indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures.
3. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
4. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at enrollment visit before first administration of Investigational Product (IP) in this study.
5. WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of IP.
6. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP.
Exclusion Criteria:
1. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib administration, unless associated with an ongoing AE and discussed with the Sponsor's medical monitor (MM) (or designee).
2. Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.
Study design
Enrollment target: 330 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-09-03
Estimated completion: 2026-12
Last updated: 2026-07-29
Interventions
Drug: SeralutinibDevice: Gereic Dry Powder Inhaler
Primary outcomes
- • Incidence of treatment-emergent adverse events (TEAEs) (From baseline to end of study (up to 48 months or availability of commercial product))
Sponsor
Gossamer Bio USA, Inc. · industry
Contacts & investigators
ContactGB002 Inc. · contact · ClinicalTrials@gossamerbio.com · 1-866-668-4083
InvestigatorRichard Aranda, MD · study_director, Gossamer Bio USA, Inc.
All locations (120)
Valley Advanced Lung Diseases InstituteRecruiting
Fresno, California, United States
Department of Veterans Affairs Greater Los Angeles Healthcare SystemRecruiting
Los Angeles, California, United States
UC Davis Health Medical CenterRecruiting
Sacramento, California, United States
Stanford HealthcareRecruiting
Stanford, California, United States
University of Florida HealthRecruiting
Gainesville, Florida, United States
Mayo Clinic JacksonvilleRecruiting
Jacksonville, Florida, United States
Piedmont Physicians Pulmonary & Sleep Medicine of BuckheadRecruiting
Atlanta, Georgia, United States
The Emory ClinicRecruiting
Atlanta, Georgia, United States
Northside Hospital - AtlantaRecruiting
Atlanta, Georgia, United States
UI Health HospitalRecruiting
Chicago, Illinois, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Norton Pulmonary SpecialistsRecruiting
Louisville, Kentucky, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
University of New Mexico Health Sciences CenterCompleted
Albuquerque, New Mexico, United States
NYU Langone HealthRecruiting
New York, New York, United States
University of Rochester Medical CenterRecruiting
Rochester, New York, United States
UNC HospitalsCompleted
Chapel Hill, North Carolina, United States
University of Cincinnati Medical CenterRecruiting
Cincinnati, Ohio, United States
INTEGRIS Cardiovascular PhysiciansActive Not Recruiting
Oklahoma City, Oklahoma, United States
The Hospital of the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Temple Heart and Vascular Institute (Outpatient Clinic)Recruiting
Philadelphia, Pennsylvania, United States
UPMC Presbyterian HospitalRecruiting
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina - Nexus Research CenterRecruiting
Charleston, South Carolina, United States
UT Southwestern Medical CenterRecruiting
Dallas, Texas, United States
CHI St. Luke's Health Baylor College of Medicine Medical CenterRecruiting
Houston, Texas, United States
Houston Methodist Outpatient CenterCompleted
Houston, Texas, United States
University of Texas Health Science Center at San AntonioRecruiting
San Antonio, Texas, United States
Intermountain Medical CenterRecruiting
Murray, Utah, United States
University of Utah HospitalRecruiting
Salt Lake City, Utah, United States
Inova Fairfax Medical CampusRecruiting
Falls Church, Virginia, United States
Pulmonary Associates of Richmond, Inc.Recruiting
Richmond, Virginia, United States
Cardiologia PalermoRecruiting
Buenos Aires, Argentina
Instituto de Cardiologia de Corrientes Juana Francisca CabralRecruiting
Corrientes, Argentina
Instuto de Investigacion Clinicas QuilmesRecruiting
Quilmes, Argentina
Instituto Medico Rio CuartoRecruiting
Río Cuarto, Argentina
Hospital Provincial Dr. Jose Maria CullenRecruiting
Santa Fe, Argentina
Pulmonary Hypertension Research QueenslandRecruiting
Auchenflower, Australia
St Vincent's Hospital (Melbourne)Recruiting
Fitzroy, Australia
Royal Hobart HospitalRecruiting
Hobart, Australia
Hopital ErasmeWithdrawn
Anderlecht, Belgium
University Hospitals of Leuven (Campus Gasthuisberg)Recruiting
Leuven, Belgium
Instituto das Pequenas Missionarias de Maria Imaculada - Hospital Madre TeresaRecruiting
Belo Horizonte, Brazil
Complexo de Prevencao, Diagnostico, Terapia e Reabilitacao Respiratoria - Hospital Dia di PulmaoRecruiting
Blumenau, Brazil
Irmandade da Santa Casa de Misericórdia de Porto AlegreRecruiting
Porto Alegre, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRSRecruiting
Porto Alegre, Brazil
Instituto do Coracao do Hospital das Clinicas da Faculdade de medicina da Universidade de Sao PauloRecruiting
São Paulo, Brazil
Nucleo de Gestao de Pesquisa/Hospital Sao Paulo - SPDM/UNIFESPActive Not Recruiting
São Paulo, Brazil
Peter Lougheed CenterRecruiting
Calgary, Canada
London Health Sciences Centre - Victoria HospitalRecruiting
London, Canada
University of Ottawa Heart InstituteActive Not Recruiting
Ottawa, Canada
University Health Network, Toronto General HospitalCompleted
Toronto, Canada
Centro de Investigacion Clinica UC-CICUCRecruiting
Santiago, Chile
Enroll SpARecruiting
Santiago, Chile
Fundacion Abood ShaioRecruiting
Bogotá, Colombia
Fundacion Neumologica ColombianaRecruiting
Bogotá, Colombia
Institut klinicke a experimentalni mediciny Klinika kardiologie Ambulance plicni hypertenzeRecruiting
Prague, Czechia
Všeobecná fakultní nemocnice v Praze ll. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hvpertenziRecruiting
Prague, Czechia
Aarhus UniversiteshospitalRecruiting
Aarhus, Denmark
CHU Bicetre, Service de Pneumologie et Reanimation RespiratorieRecruiting
Le Kremlin-Bicêtre, France
Centre Hospitalier REgional Universitaire de Lille Hopital Cardiologique - Institut Coeur Poumon Service de CardiologieRecruiting
Lille, France
CHU de Nice - Hopital PasteurCompleted
Nice, France
CHU de PoitiersRecruiting
Poitiers, France
Zentrum fur Pulmonale Hypertonie, Klinik Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternistische lntensivmedizin), Herzzentrum der Universitat zu KolnRecruiting
Cologne, Germany
Universitätsklinikum Dresden, Medizinische Klinik I / Pneumologisches StudiensekretariatWithdrawn
Dresden, Germany
Universitatsklinikum Giessen und Marburg GmbH Zentrum fur lnnere Medizin, Med. Klinik und Poliklinik II Studienambulanz fur Pulmonale HypertonieRecruiting
Giessen, Germany
Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale HypertonieRecruiting
Heidelberg, Germany
Klinikum der LMU Medizinische Klinik und Poliklinik VRecruiting
Munich, Germany
Krankenhaus NeuwittelsbachRecruiting
München, Germany
Klinikum Würzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und BeatmungsmedizinRecruiting
Würzburg, Germany
"Evangelismos" General Hospital of Athens, 1st Department of Clinical Care and Pulmonary Hypertension ClinicRecruiting
Athens, Greece
ATTIKON University Hospital, 2nd Critical Care DepartmentRecruiting
Athens, Greece
Onassis Cardiac Surgery Center, Non-Invasive Cardiology DepartmentCompleted
Kallithea, Greece
AHEPA University General Hospital of Thessaloniki, 1st Cardiology ClinicRecruiting
Thessaloniki, Greece
Mater Misericordiae University HospitalRecruiting
Dublin, Ireland
Lady Davis Carmel Medical CenterRecruiting
Haifa, Israel
IRCCS Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - UOC CardiologiaRecruiting
Bologna, Italy
Azienda Ospedaliera Dei Colli - Ospedale MonaldiRecruiting
Naples, Italy
Fondazione IRCCS Policlinico San MatteoRecruiting
Pavia, Italy
A.O.U. Policlinico Umberto IRecruiting
Roma, Italy
University of Tokyo HospitalRecruiting
Bunkyō City, Japan
Kyushu University HospitalRecruiting
Fukuoka, Japan
Kyorin University HospitalRecruiting
Mitaka, Japan
Nagoya University HospitalRecruiting
Nagoya, Japan
NHO Okayama Medical CenterRecruiting
Okayama, Japan
Keio University HospitalRecruiting
Shinjuku-Ku, Japan
National Cerebral and Cardiovascular CenterRecruiting
Suita, Japan
Pauls Stradins Clinical University HospitalRecruiting
Riga, Latvia
Hospital of Lithuanian University of Health Sciences Kauno klinikosRecruiting
Kaunas, Lithuania
Instituto Nacional de Cardiologia Ignacio ChavezRecruiting
Mexico City, Mexico
Unidad de Investigacion Clinica en Medicina, S.C.Recruiting
Monterrey, Mexico
Amsterdam UMC, location VU mcCompleted
Amsterdam, Netherlands
Erasmus MCWithdrawn
Rotterdam, Netherlands
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn z Pododdzialem Intensywnego Nadzoru KardiologicznegoRecruiting
Krakow, Poland
Europejskie Centrum Zdrowia Otwock Sp.zo.o. Szpital im. Fryderyka Chopina Oddzial KardiologicznyRecruiting
Otwock, Poland
Unidade Local de Saude de Santa Maria, E.P.E. Hospital Pulido ValenteRecruiting
Lisbon, Portugal
Unidade Local de Saude de Santo Antonio, E.P.E. Hospital de Santo AntonioRecruiting
Porto, Portugal
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Cardiology 2Recruiting
Bucharest, Romania
"Niculae Stancioiu" Emergency Heart Institute for Cardiovascular Diseases, Cardiology 1 DepartmentRecruiting
Cluj-Napoca, Romania
King Fahad Medical CityCompleted
Riyadh, Saudi Arabia
King Faisal Specialist Hospital and Research CenterCompleted
Riyadh, Saudi Arabia
University Clinical Centre of Serbia, Cardiology ClinicRecruiting
Belgrade, Serbia
National Heart Centre SingaporeRecruiting
Singapore, Singapore
National University Heart CentreWithdrawn
Singapore, Singapore
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health SystemWithdrawn
Seoul, South Korea
Hospital Clinic I ProvincialRecruiting
Barcelona, Spain
Hospital Universitario 12 De OctubreRecruiting
Madrid, Spain
Hospital Universitario Marques de ValdecillaRecruiting
Santander, Spain
Hospital Universitario Virgen del RocioCompleted
Seville, Spain
Hospital Universitario de ToledoCompleted
Toledo, Spain
Royal Papworth Hospital NHS Foundation TrustRecruiting
Cambridge, United Kingdom
Golden Jubilee National HospitalRecruiting
Clydebank, United Kingdom
Hammersmith HospitalCompleted
London, United Kingdom
Royal Free Hospital, Clinical Research FacilityRecruiting
London, United Kingdom
Freeman HospitalRecruiting
Newcastle, United Kingdom
Royal Hallamshire HospitalRecruiting
Sheffield, United Kingdom