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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified January 2026 by GB002, Inc.
Sponsor
GB002, Inc.
Information Provided by (Responsible Party)
GB002, Inc.
Clinicaltrials.gov Identifier
NCT06274801
Other Study ID Numbers:
GB002-3102
First Submitted
January 18, 2024
First Posted
February 22, 2024
Last Update Posted
June 24, 2026
Last Verified
January 2026

ClinicalTrials.gov processed this data on June 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.

Condition or DiseaseIntervention/Treatment
Pulmonary Arterial Hypertension
Drug: Seralutinib

Study Design

Study TypeInterventional
Actual Enrollment316 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleAn Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)
Study Start DateSeptember 2, 2024
Actual Primary Completion Date4mos 4w from now
Actual Study Completion Date4mos 4w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Seralutinib 90 mg
Seralutinib inhaled orally twice per day (BID)
Drug: Seralutinib
Capsule containing seralutinib

Outcome Measures

Primary Outcome Measures
  1. Incidence of treatment-emergent adverse events (TEAEs)
Secondary Outcome Measures
  1. Changes in distance achieved on the Six-Minute Walk Test (6MWT)
    Δ6MWT from Baseline to End of Study
  2. Changes in NT-proBNP
    Change in NT-proBNP from Baseline to End of Study

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsGB002, Inc.
Locations
Valley Advanced Lung Diseases Institute | Fresno California, United States, 93720Department of Veterans Affairs Greater Los Angeles Healthcare System | Los Angeles California, United States, 90073UC Davis Health Medical Center | Sacramento California, United States, 95817Stanford Healthcare | Stanford California, United States, 94305University of Florida Health | Gainesville Florida, United States, 32610Mayo Clinic Jacksonville | Jacksonville Florida, United States, 32224Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead | Atlanta Georgia, United States, 30309The Emory Clinic | Atlanta Georgia, United States, 30322Northside Hospital - Atlanta | Atlanta Georgia, United States, 30342UI Health Hospital | Chicago Illinois, United States, 60612University of Kansas Medical Center | Kansas City Kansas, United States, 66160Norton Pulmonary Specialists | Louisville Kentucky, United States, 40202University of Michigan | Ann Arbor Michigan, United States, 48109Washington University School of Medicine | St Louis Missouri, United States, 63110University of Nebraska Medical Center | Omaha Nebraska, United States, 68198University of New Mexico Health Sciences Center | Albuquerque New Mexico, United States, 87131NYU Langone Health | New York New York, United States, 10016University of Rochester Medical Center | Rochester New York, United States, 14642UNC Hospitals | Chapel Hill North Carolina, United States, 27514University of Cincinnati Medical Center | Cincinnati Ohio, United States, 45219INTEGRIS Cardiovascular Physicians | Oklahoma City Oklahoma, United States, 73112The Hospital of the University of Pennsylvania | Philadelphia Pennsylvania, United States, 19104Temple Heart and Vascular Institute (Outpatient Clinic) | Philadelphia Pennsylvania, United States, 19140UPMC Presbyterian Hospital | Pittsburgh Pennsylvania, United States, 15213Medical University of South Carolina - Nexus Research Center | Charleston South Carolina, United States, 29425UT Southwestern Medical Center | Dallas Texas, United States, 75390CHI St. Luke's Health Baylor College of Medicine Medical Center | Houston Texas, United States, 77030Houston Methodist Outpatient Center | Houston Texas, United States, 77030University of Texas Health Science Center at San Antonio | San Antonio Texas, United States, 78229Intermountain Medical Center | Murray Utah, United States, 84107University of Utah Hospital | Salt Lake City Utah, United States, 84132Inova Fairfax Medical Campus | Falls Church Virginia, United States, 22042Pulmonary Associates of Richmond, Inc. | Richmond Virginia, United States, 23230Cardiologia 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, 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, 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, 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, Asan Medical Center | Seoul , South Korea, Samsung Medical Center | Seoul , South Korea, Seoul National University Hospital | 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,
Investigators
Study Director: Richard Aranda, MD, Gossamer Bio Inc.