Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
Recruiting · NCT06274801 · Interventional (participants receive a specific treatment) · Lead sponsor: Gossamer Bio USA, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Gereic Dry Powder InhalerSeralutinib
What this trial is about
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
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
60 locations listed across 19 US states.
- 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
- Aarhus Universiteshospital - Aarhus, Denmark
- Amsterdam UMC, location VU mc - Amsterdam, Netherlands
- Hopital Erasme - Anderlecht, Belgium
- "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
- Pulmonary Hypertension Research Queensland - Auchenflower, Australia
- Hospital Clinic I Provincial - Barcelona, Spain
- University Clinical Centre of Serbia, Cardiology Clinic - Belgrade, Serbia
- 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
- Fundacion Abood Shaio - Bogotá, Colombia
- Fundacion Neumologica Colombiana - Bogotá, Colombia
- IRCCS Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - UOC Cardiologia - Bologna, Italy
- Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Cardiology 2 - Bucharest, Romania
- Cardiologia Palermo - Buenos Aires, Argentina
- University of Tokyo Hospital - Bunkyō City, Japan
- Peter Lougheed Center - Calgary, Canada
- Royal Papworth Hospital NHS Foundation Trust - Cambridge, United Kingdom
- "Niculae Stancioiu" Emergency Heart Institute for Cardiovascular Diseases, Cardiology 1 Department - Cluj-Napoca, Romania
- Golden Jubilee National Hospital - Clydebank, United Kingdom
- Zentrum fur Pulmonale Hypertonie, Klinik Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternistische lntensivmedizin), Herzzentrum der Universitat zu Koln - Cologne, Germany
- Instituto de Cardiologia de Corrientes Juana Francisca Cabral - Corrientes, Argentina
- Universitätsklinikum Dresden, Medizinische Klinik I / Pneumologisches Studiensekretariat - Dresden, Germany
- Mater Misericordiae University Hospital - Dublin, Ireland
- St Vincent's Hospital (Melbourne) - Fitzroy, Australia
- Kyushu University Hospital - Fukuoka, Japan
- Universitatsklinikum Giessen und Marburg GmbH Zentrum fur lnnere Medizin, Med. Klinik und Poliklinik II Studienambulanz fur Pulmonale Hypertonie - Giessen, Germany
Showing 60 of 120 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →