Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)
NCT ID: NCT05934526
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
390 participants
INTERVENTIONAL
2023-12-28
2025-12-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
NCT06274801
Efficacy and Safety of Seralutinib in Adult Subjects With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
NCT07181382
GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
NCT04456998
Selonsertib in Adults With Pulmonary Arterial Hypertension
NCT02234141
Characterization and Detection of Prolonged Endothelin Receptors Antagonists Administration
NCT01352065
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo inhaled orally twice daily (BID) up to 48 weeks
Generic Dry Powder Inhaler
Generic dry powder inhaler for seralutinib or placebo delivery
Placebo
Matching capsule containing placebo
Seralutinib 90 mg
Seralutinib inhaled orally BID up to 48 weeks
Seralutinib
Capsule containing seralutinib
Generic Dry Powder Inhaler
Generic dry powder inhaler for seralutinib or placebo delivery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Seralutinib
Capsule containing seralutinib
Generic Dry Powder Inhaler
Generic dry powder inhaler for seralutinib or placebo delivery
Placebo
Matching capsule containing placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Body mass index (BMI) ≥ 15 kg/m\^2 and ≤ 40 kg/m\^2.
3. Diagnosis of PAH classified by one of the following:
1. Idiopathic PAH (IPAH) or heritable PAH (HPAH).
2. PAH associated with connective tissue disease (CTD-APAH); PAH associated with anorexigen or PAH associated with methamphetamine use.
3. Congenital heart disease with simple systemic to pulmonary shunt at least 1 year after surgical repair.
4. 6MWDs ≥ 150 meters and ≤ 475 meters during Screening prior to randomization.
5. WHO FC II or III.
6. US Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) Lite 2 Risk Score ≥ 5 OR NT-proBNP ≥ 300 ng/L OR PVR ≥ 800 dyne s/cm\^5.
7. Cardiac catheterization within the screening period, or a standard of care right heart catheterization (RHC) (with pressure wave forms available for review) up to 48 weeks prior to Screening.
1. Mean pulmonary arterial pressure (mPAP) \> 20 mmHg (at rest), AND
2. Pulmonary vascular resistance (PVR) ≥ 400 dyne·s/cm\^5, AND
3. Pulmonary capillary wedge pressure (PCWP) or left ventricle end-diastolic pressure (LVEDP) ≤ 15 mmHg.
8. Treatment with at least one allowed background PAH disease-specific medication prior to Screening.
1. Subjects receiving treatment with endothelin receptor antagonists, phosphodiesterase type 5 inhibitors, guanylate cyclase stimulators, and/or prostacyclin analogues or prostacyclin receptor agonists are eligible only if on a stable dose for at least 12 weeks prior to and throughout Screening.
2. Subjects receiving treatment with sotatercept are eligible only if on a stable dose of sotatercept for at least 24 weeks prior to and throughout Screening, with a RHC performed during Screening (or within 2 weeks prior to Screening).
9. Pulmonary function tests (PFTs) at Screening or completed no more than 12 weeks prior to Screening.
10. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and on Day 1 before first administration of Investigational Product (IP).
11. 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.
12. 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
2. Uncontrolled systemic hypertension as evidenced by systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg.
3. Systolic blood pressure \< 90 mm Hg during Screening.
4. WHO Pulmonary Hypertension Group 2 - 5.
5. Human immunodeficiency virus (HIV)-associated PAH, schistosomiasis associated PAH, PAH associated with portal hypertension, or pulmonary veno-occlusive disease (PVOD).
6. Recent history of left-sided heart disease and/or clinically significant cardiac disease within 48 weeks of Screening.
7. Left ventricular ejection fraction (LVEF) ≤ 50% within 24 weeks of Screening.
8. Hemodynamically significant valvular heart disease or uncontrolled symptomatic coronary disease.
9. History of atrial septostomy.
10. Uncontrolled atrial fibrillation or paroxysmal atrial fibrillation.
11. Untreated severe obstructive sleep apnea.
12. Hepatic dysfunction defined as Child-Pugh Class A or higher, or as evidenced by one of the following at Screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 1.5 x upper limit of normal (ULN) or total bilirubin ≥ 1.5 x ULN.
13. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or IP administration (eg, history of intracranial hemorrhage, recurrent syncope).
14. Any musculoskeletal disease, injury, or any other disease that limits evaluation of 6MWT.
15. Initiation of an exercise program for cardiopulmonary rehabilitation within 12 weeks prior to Screening or planned during the study.
16. Pregnant or nursing or intends to become pregnant during the duration of the study.
17. Body weight \< 37 kg at Screening.
18. Estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73m\^2 Hemoglobin (Hgb) concentration \< 8.5 g/dL at Screening.
19. Evidence of active or latent Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C, or tuberculosis (TB) infection at Screening.
20. Prior/concurrent treatment with tyrosine kinase inhibitors or activin signaling inhibitors:
1. Tyrosine kinase inhibitors, other than Janus kinase inhibitors approved for systemic autoimmune rheumatic diseases, within 12 weeks prior to Screening.
2. Activin signaling inhibitors within 5 half-lives prior to Screening.
21. Requirement of IV inotropes (ie, levosimendan, dopamine, dobutamine, milrinone, norepinephrine) or IV diuretics for more than 24 hours within 4 weeks prior to Screening.
22. Subjects currently receiving oral anticoagulants (ie, warfarin/other vitamin K antagonists or direct-acting oral anticoagulants \[DOACs\]) if any of the following criteria are met:
a. History within 24 weeks of Screening of: i. Syncope, or ii. Symptomatic bleeding in a critical area or organ iii. Intramuscular with compartment syndrome, or iv. Bleeding causing a fall in hemoglobin levels of 1.24 mmol/L (20 g/L or greater) or more, or v. Bleeding leading to a transfusion of 2 U or more of whole blood or red blood cells.
b. History of central nervous system pathology.
c. History of clinically significant (massive) hemoptysis.
d. If on warfarin/other vitamin K antagonist, uncontrolled International normalized ratio (eg, INR \> 3) as assessed.
e. Platelet count \< 150 x 10\^9/L at Screening.
f. Concomitant use of antiplatelet agents.
g. CTD-APAH
h. Concomitant use of sotatercept.
23. Prior participation in seralutinib studies and/or prior treatment with seralutinib.
24. Currently participating in or has participated in a study of an investigational agent or has used an investigational device for the treatment of PAH within 12 weeks or 5 half-lives of the investigational agent, whichever is longer, prior to Screening.
25. Current use of inhaled tobacco- or nicotine-containing products (including e-vapor products) and/or inhaled marijuana.
26. Current alcohol use disorder based on the opinion of the Investigator, and/or a positive test for drugs of abuse.
27. Subjects with a history of severe milk protein allergy or known intolerance to lactose.
28. QT interval corrected for heart rate using Fridericia's formula (QTcF) of \> 500 msec.
29. Have any other condition or reason that, in the opinion of the Investigator or in the opinion of the Sponsor's Medical Monitor (MM) (or designee) in consultation with the Investigator, would prohibit the subject from participating in the study.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GB002, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Richard Aranda, MD
Role: STUDY_DIRECTOR
Gossamer Bio Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Valley Advanced Lung Diseases Institute
Fresno, California, United States
Keck Medical Center of USC
Los Angeles, California, United States
Dept of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, United States
University of California, Irvine Medical Center
Orange, California, United States
UC Davis Health
Sacramento, California, United States
Stanford Healthcare
Stanford, California, United States
Winchester Center for Lung Disease
New Haven, Connecticut, United States
The George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
University of Florida Clinical Research Center
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Northside Hospital Laboratory - Atlanta
Atlanta, Georgia, United States
UI Health Hospital
Chicago, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Norton Hospital
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, United States
University of Missouri
Columbia, Missouri, 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
Duke University Medical Center - Duke South
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
INTEGRIS Cardiovascular Physicians, LLC
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, 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
Rhode Island Hospital
Providence, Rhode Island, 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
Baylor Scott & White Medical Center - The Heart Hospital
Plano, 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
Advocate Aurora Health-Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Froedtert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Cardiologia Palermo
Buenos Aires, , Argentina
Instituto Cardiovascular de Buenos Aires
Buenos Aires, , Argentina
Instituto de Cardiologia de Corrientes Juana Francisca Cabral
Corrientes, , Argentina
Hospital Privado Centro Medico de Cordóba S.A.
Córdoba, , Argentina
Instituto de Investigaciones Clinicas Quilmes
Quilmes, , Argentina
Instituto Medico Rio Cuarto
Río Cuarto, , Argentina
Sanatorio Parque S.A.
Rosario, , Argentina
Hospital Provincial Dr. José María Cullen
Santa Fe, , Argentina
St Vincent's Hospital
Melbourne, Victoria, Australia
Wesley Research Institute
Auchenflower, , Australia
Royal Hobart Hospital
Hobart, , Australia
Nepean Hospital
Kingswood, , Australia
Religious Hospital Linz GmbH
Linz, , Austria
AKH-Vienna Medical Univesity of Vienna Internal Medicine II-Cardiology
Vienna, , Austria
Hôpital Erasme
Anderlecht, , Belgium
University Hospitals of Leuven (Campus Gasthuisberg)
Leuven, , Belgium
Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
Belo Horizonte, , Brazil
Complexo de Prevencao, Diagnostico, Terapia e Reabilitacao Respiratoria - Hospital Dia do Pulmao
Blumenau, , Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, , Brazil
Uniao Brasileira de Educaçao e Assistência Hospital São Lucas da PUCRS
Porto Alegre, , Brazil
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, , Brazil
Núcleo de Gestão de Pesquisa/Hospital São Paulo - SPDM/UNIFESP
São Paulo, , Brazil
London Health Science Centre - Victoria Hospital
London, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Peter Lougheed Center
Calgary, , Canada
University Health Network
Toronto, , Canada
Enroll SpA
Santiago, Santiago Metropolitan, Chile
Centro de Investigacion Clinica UC-CICUC
Santiago, , Chile
Fundación Abood Shaio
Bogotá, , Colombia
Fundación Neumologica Colombiana
Bogotá, , Colombia
Institut Klinicke a Experimentalni Mediciny
Prague, , Czechia
Všeobecná fakultní nemocnice v Praze Il. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hypertenzi
Prague, , Czechia
Aarhus Universitetshospital, Department of Cardiology
Aarhus, , Denmark
Rigshospitalet, Department of Cardiology
Copenhagen, , Denmark
CHU Bicêtre
Le Kremlin-Bicêtre, , France
Institut Coeur Poumon
Lille, , France
CHU de Montpellier
Montpellier, , France
Hôpital Pasteur
Nice, , France
CHU de Poitiers
Poitiers, , France
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Centre Hospitalier Universitaire - Hôpital d´Adultes de Brabois
Vandœuvre-lès-Nancy, , France
DRK Kliniken Berlin Westend
Berlin, , Germany
Zentrum fur Pulmona le Hypertonie, Klini k Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternlstische lntensiv medizin), Herzzentrum der Universitat zu Koln
Cologne, , Germany
Universitatsklinikum Dresden, Medizinische Klinik / Pneumologisches Studiensekretariat
Dresden, , Germany
Universitatsklinikum Giessen und Marburg GmbH Zentrum fur Innere Medizin, Med. Klinik und Poliklinik II Studienambulanz fur Pulmonale Hypertonie
Giessen, , Germany
Universitätsklinikum Greifswald Klinik und Poliklinik für Innere Medizin B
Greifswald, , Germany
Universitätsklinikum Halle (Saale) / Martin-Luther-Universität Halle- Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I
Halle, , Germany
Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie
Heidelberg, , Germany
Krankenhaus Neuwittelsbach
Munich, , Germany
Klinikum der LMU Medizinische Klinik und Poliklinik V
München, , Germany
Klinikum Wurzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin
Würzburg, , Germany
"Evangelismos" General Hospital, 1st Department of Clinical Care & Pulmonary Hypertension Clinic
Athens, , Greece
ATTIKON University Hospital, 2nd Critical Care Department
Athens, , Greece
Onassis Cardiac Surgery Center
Kallithea, , Greece
AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic
Thessaloniki, , Greece
Mater Misericordiae University Hospital, Respiratory Department
Dublin, , Ireland
Lady Davis Carmel Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center
Petah Tikva, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
IRCCS Azienda Ospedaliero Universitaria Di Bologna Policlinico 5 Orsola Malpighi - U.O.C. Cardiologia
Bologna, , Italy
Azienda Ospedaliera Dei Colli - Ospedale Monaldi Centro per la Diagnosi e Terapia dell'Ipertensione Polmonare
Napoli, , Italy
Fondazione IRCCS Policlinico San Matteo - U.O. di Cardiologia
Pavia, , Italy
Azienda Ospealiero Universitaria Policlinico Umberto I - Dipartamento di Scienze Cliniche Internistiche Anestesiologiche e Cardiovascolari - VIII Padglione
Rome, , Italy
Azienda Sanitaria Universitaria Giuliano Isontina /ASUGI - Ospedale di Cattinara - Cardiovascular Department Coronary Intensive Care Unit
Trieste, , Italy
Kyushu University Hospital
Fukuoka, , Japan
Kurume University Hospital
Kurume, , 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
Kyorin University Hospital
Tokyo, , Japan
University of Tokyo Hospital
Tokyo, , 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
Hospital Universitario Dr. José Eleuterio González Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas
Monterrey, , Mexico
Unidad de Investigacion Clinica en Medicina, S.C.
Monterrey, , Mexico
Amsterdam UMC, location VUmc
Amsterdam, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Krakowski Szpital Specjalistyczny Im. Św. Jana Pawła II Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego
Krakow, , Poland
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Szpital irn. Fryderyka Chopina Oddzial Kardiologiczny
Otwock, , Poland
Centro Hospitalar e Universitário de Coimbra
Coimbra, , Portugal
Centro Hospitalar Universitário Lisboa Norte, EPE - Hospital Pulido Valente
Lisbon, , Portugal
Centro Hospitalar Universitário de Santo António
Porto, , Portugal
Emergency Institute of Cardiovascular Diseases "Prof. Dr. C.C. Iliescu" Bucharest, Cardiology 2
Bucharest, , Romania
"Niculae Stanciolu" Emergency Heart Institute for Cardivascular Diseases
Cluj-Napoca, , Romania
Mediprax Centrum S.R.L
Cluj-Napoca, , Romania
Targu-Mures Emergency Clinical County Hospital, Internal Medicine II
Târgu Mureş, , Romania
King Fahad Medical City
Riyadh, , Saudi Arabia
King Faisal Specialist Hospital and Research Center
Riyadh, , Saudi Arabia
Institute for Cardiovascular Diseases "Dedinje" Clinic for Cardiology
Belgrade, , Serbia
University Clinical Centre of Serbia, Cardiology Clinic
Belgrade, , Serbia
National Heart Centre Singapore
Singapore, , Singapore
National University Heart Centre Singapore
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
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary´s Hospital
Seoul, , South Korea
Hospital Clinic I Provincial
Barcelona, , Spain
Hospital Universitario 12 De Octubre
Madrid, , Spain
Hospital Universitario Puerta De Hierro Majadahonda
Majadahonda, , Spain
Hospital Costa del Sol
Marbella, , Spain
Hospital Universitario Son Espases
Palma de Mallorca, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitario de Toledo
Toledo, , Spain
Royal Papworth Hospital NHS Foundation Trust
Cambridge, , United Kingdom
Golden Jubilee National Hospital, Agamemnon Street
Clydebank, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Royal Brompton Hospital, Pulmonary Hypertension Service, Sydney Street
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Sheffield Clinical Research Facility, Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sitbon O, Sahay S, Escribano Subias P, Zolty RL, Kingrey JF, Ryan JJ, Sobol I, Sood N, Benza RL, Channick RN, Chin KM, Frantz RP, Ghofrani HA, Hemnes AR, McLaughlin VV, Vachiery JL, Zamanian RT, Ter Veer A, Roscigno RF, Mottola D, Parsley E, Aranda R, Zisman LS, Howard LS; TORREY Study Investigators. Seralutinib for the Treatment of Pulmonary Arterial Hypertension in Adults: TORREY Open-Label Extension Study. Adv Ther. 2025 Oct;42(10):5104-5123. doi: 10.1007/s12325-025-03297-2. Epub 2025 Aug 11.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-503614-80-00
Identifier Type: OTHER
Identifier Source: secondary_id
GB002-3101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.