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)
2 other identifiers
interventional
330
30 countries
120
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2024
120 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2024
CompletedFirst Posted
Study publicly available on registry
February 23, 2024
CompletedStudy Start
First participant enrolled
September 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
July 29, 2026
July 1, 2026
2.2 years
January 19, 2024
July 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of treatment-emergent adverse events (TEAEs)
From baseline to end of study (up to 48 months or availability of commercial product)
Secondary Outcomes (2)
Changes in distance achieved on the Six-Minute Walk Test (6MWT)
Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)
Changes in NT-proBNP
Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)
Study Arms (1)
Seralutinib 90 mg
EXPERIMENTALSeralutinib inhaled orally twice per day (BID)
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.
- 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.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- 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.
- 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.
- 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.
You may not qualify if:
- 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).
- Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (120)
Valley Advanced Lung Diseases Institute
Fresno, California, 93720, United States
Department of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
UC Davis Health Medical Center
Sacramento, California, 95817, United States
Stanford Healthcare
Stanford, California, 94305, United States
University of Florida Health
Gainesville, Florida, 32610, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta, Georgia, 30309, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Northside Hospital - Atlanta
Atlanta, Georgia, 30342, United States
UI Health Hospital
Chicago, Illinois, 60612, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Norton Pulmonary Specialists
Louisville, Kentucky, 40202, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131, United States
NYU Langone Health
New York, New York, 10016, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
UNC Hospitals
Chapel Hill, North Carolina, 27514, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
INTEGRIS Cardiovascular Physicians
Oklahoma City, Oklahoma, 73112, United States
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Temple Heart and Vascular Institute (Outpatient Clinic)
Philadelphia, Pennsylvania, 19140, United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina - Nexus Research Center
Charleston, South Carolina, 29425, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston, Texas, 77030, United States
Houston Methodist Outpatient Center
Houston, Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042, United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23230, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Richard Aranda, MD
Gossamer Bio USA, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2024
First Posted
February 23, 2024
Study Start
September 3, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
July 29, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share