Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified January 2026 by GB002, Inc.
Sponsor
GB002, Inc.
Information Provided by (Responsible Party)
GB002, Inc.
Clinicaltrials.gov Identifier
NCT05934526
Other Study ID Numbers:
GB002-3101
First Submitted
June 27, 2023
First Posted
July 6, 2023
Last Update Posted
May 18, 2026
Last Verified
January 2026

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

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Pulmonary Arterial Hypertension
Drug: PlaceboDrug: Seralutinib

Study Design

Study TypeInterventional
Actual Enrollment390 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)
Study Start DateDecember 27, 2023
Actual Primary Completion DateNovember 26, 2025
Actual Study Completion DateDecember 21, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
Placebo
Placebo inhaled orally twice daily (BID) up to 48 weeks
Drug: Placebo
Matching capsule containing placebo
Seralutinib 90 mg
Seralutinib inhaled orally BID up to 48 weeks
Drug: Seralutinib
Capsule containing seralutinib

Outcome Measures

Primary Outcome Measures
  1. Change in distance achieved on the six-minute walk test (6MWT), six-minute walk distance (Δ6MWD) from baseline to Week 24
Secondary Outcome Measures
  1. Time to first event of Clinical Worsening from first dose of Investigational Product (IP) through end of study
  2. Proportion of subjects who achieve all of the following components of clinical improvement at Week 24, in the absence of clinical worsening:
    1. Improvement from baseline in World Health Organization (WHO) functional class (FC) or maintenance of WHO FC II 2. Decrease from baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) of ≥ 30% or decrease and maintenance at \< 300 ng/L 3. Increase from baseline in 6MWD of ≥ 10% or ≥ 30 m
  3. Change in NT-proBNP from baseline to Week 24
  4. Proportion of subjects with ≥ 1 point decrease from baseline in US Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) Lite 2 Risk Score at Week 24
  5. Proportion of subjects with each of the Clinical Worsening Outcomes:
    1. Death (all causes) 2. Hospitalization for signs and symptoms of worsening PAH (≥ 24 hours) 3. Worsening-related listing for or receipt of lung and/or heart/lung transplantation 4. Atrial septostomy performed 5. Worsening PAH requiring initiation of therapy with an additional approved background PAH disease-specific medication or the need to increase the dose of parenteral (IV or subcutaneous infusion) prostacyclin by 10% or more 6. Disease progression, defined by both of the following events occurring at any time, even if they began at different times, as compared to their baseline values: 1. Decrease in 6MWD of ≥ 15% on two consecutive tests, performed a minimum of 4 hours but no more than 1 week apart AND 2. Worsened WHO FC
  6. Proportion of subjects who improve from baseline in WHO FC or maintain WHO FC II
  7. Change in PAH-SYMPACT™ from baseline to Week 24
  8. Change in Euro-QoL - 5 Dimensions - 5 Levels (EQ-5D-5L) from baseline to Week 24
  9. Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs (SAEs), and treatment-emergent adverse events of special interest (AESIs)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. Adult subjects aged 18 to 75 years. 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
1. Evidence of chronic thromboembolic disease or acute pulmonary embolism. 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.

Contacts and Locations

Sponsors and CollaboratorsGB002, Inc.
Locations
University of Alabama at Birmingham | Birmingham Alabama, United States, 35233Valley Advanced Lung Diseases Institute | Fresno California, United States, 93711Keck Medical Center of USC | Los Angeles California, United States, 90033Dept of Veterans Affairs Greater Los Angeles Healthcare System | Los Angeles California, United States, 90073University of California, Irvine Medical Center | Orange California, United States, 92868UC Davis Health | Sacramento California, United States, 95817Stanford Healthcare | Stanford California, United States, 94305Winchester Center for Lung Disease | New Haven Connecticut, United States, 06519The George Washington University Medical Faculty Associates | Washington D.C. District of Columbia, United States, 20037University of Florida Clinical Research Center | Gainesville Florida, United States, 32610Mayo Clinic | Jacksonville Florida, United States, 32224Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead | Atlanta Georgia, United States, 30309Emory University | Atlanta Georgia, United States, 30322Northside Hospital Laboratory - Atlanta | Atlanta Georgia, United States, 30342UI Health Hospital | Chicago Illinois, United States, 60612University of Iowa Hospitals & Clinics | Iowa City Iowa, United States, 52242University of Kansas Medical Center | Kansas City Kansas, United States, 66160Norton Hospital | Louisville Kentucky, United States, 40202Tufts Medical Center | Boston Massachusetts, United States, 02111Massachusetts General Hospital | Boston Massachusetts, United States, 02114University of Michigan | Ann Arbor Michigan, United States, 48109M Health Fairview University of Minnesota Medical Center - East Bank | Minneapolis Minnesota, United States, 55455University of Missouri | Columbia Missouri, United States, 65212Washington 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, 27514Duke University Medical Center - Duke South | Durham North Carolina, United States, 27710University of Cincinnati Medical Center | Cincinnati Ohio, United States, 45219Cleveland Clinic Foundation | Cleveland Ohio, United States, 44195INTEGRIS Cardiovascular Physicians, LLC | Oklahoma City Oklahoma, United States, 73112Oregon Health & Science University | Portland Oregon, United States, 97239The 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, 15213Rhode Island Hospital | Providence Rhode Island, United States, 02903Medical 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, 77030Baylor Scott & White Medical Center - The Heart Hospital | Plano Texas, United States, 75024University 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, 23230Advocate Aurora Health-Aurora St. Luke's Medical Center | Milwaukee Wisconsin, United States, 53215Froedtert Hospital/Medical College of Wisconsin | Milwaukee Wisconsin, United States, 53226Cardiologia 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, 3065Wesley 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, N6A 5W9University of Ottawa Heart Institute | Ottawa Ontario, Canada, K1Y4W7Peter Lougheed Center | Calgary , Canada, University Health Network | Toronto , Canada, Enroll SpA | Santiago Santiago Metropolitan, Chile, 7500587Centro 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, 3436212Meir Medical Center | Kfar Saba , Israel, 4428164Rabin 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 | Naples , 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,
Investigators
Study Director: Richard Aranda, MD, Gossamer Bio Inc.