New inhaled drug shows promise for rare lung disease

NCT ID NCT05934526

Disease control Sponsor: GB002, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an inhaled medication called seralutinib in 390 adults with pulmonary arterial hypertension (PAH), a serious lung condition that makes it hard to breathe and limits physical activity. The goal was to see if the drug improves how far patients can walk in six minutes and delays the disease from getting worse. Participants were randomly assigned to receive either seralutinib or a placebo, and neither they nor their doctors knew which treatment they received.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

390 people

The number who actually took part.

Started

Dec 2023

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary arterial hypertension

Contacts and locations

Locations

"Evangelismos" General Hospital, 1st Department of Clinical Care & Pulmonary Hypertension Clinic

Athens, Greece
"Niculae Stanciolu" Emergency Heart Institute for Cardivascular Diseases

Cluj-Napoca, Romania
AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic

Thessaloniki, Greece
AKH-Vienna Medical Univesity of Vienna Internal Medicine II-Cardiology

Vienna, Austria
ATTIKON University Hospital, 2nd Critical Care Department

Athens, Greece
Aarhus Universitetshospital, Department of Cardiology

Aarhus, Denmark
Advocate Aurora Health-Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States
Amsterdam UMC, location VUmc

Amsterdam, Netherlands
Asan Medical Center

Seoul, South Korea
Azienda Ospealiero Universitaria Policlinico Umberto I - Dipartamento di Scienze Cliniche Internistiche Anestesiologiche e Cardiovascolari - VIII Padglione

Rome, Italy
Azienda Ospedaliera Dei Colli - Ospedale Monaldi Centro per la Diagnosi e Terapia dell'Ipertensione Polmonare

Naples, Italy
Azienda Sanitaria Universitaria Giuliano Isontina /ASUGI - Ospedale di Cattinara - Cardiovascular Department Coronary Intensive Care Unit

Trieste, Italy
Baylor Scott & White Medical Center - The Heart Hospital

Plano, Texas, 75024, United States
CHI St. Luke's Health Baylor College of Medicine Medical Center

Houston, Texas, 77030, United States
CHU Bicêtre

Le Kremlin-Bicêtre, France
CHU de Montpellier

Montpellier, France
CHU de Poitiers

Poitiers, France
Cardiologia Palermo

Buenos Aires, Argentina
Centre Hospitalier Universitaire - Hôpital d´Adultes de Brabois

Vandœuvre-lès-Nancy, France
Centro Hospitalar Universitário Lisboa Norte, EPE - Hospital Pulido Valente

Lisbon, Portugal
Centro Hospitalar Universitário de Santo António

Porto, Portugal
Centro Hospitalar e Universitário de Coimbra

Coimbra, Portugal
Centro de Investigacion Clinica UC-CICUC

Santiago, Chile
Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States
Complexo de Prevencao, Diagnostico, Terapia e Reabilitacao Respiratoria - Hospital Dia do Pulmao

Blumenau, Brazil
DRK Kliniken Berlin Westend

Berlin, Germany
Dept of Veterans Affairs Greater Los Angeles Healthcare System

Los Angeles, California, 90073, United States
Duke University Medical Center - Duke South

Durham, North Carolina, 27710, United States
Emergency Institute of Cardiovascular Diseases "Prof. Dr. C.C. Iliescu" Bucharest, Cardiology 2

Bucharest, Romania
Emory University

Atlanta, Georgia, 30322, United States
Enroll SpA

Santiago, Santiago Metropolitan, 7500587, Chile
Erasmus MC

Rotterdam, Netherlands
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Szpital irn. Fryderyka Chopina Oddzial Kardiologiczny

Otwock, Poland
Fondazione IRCCS Policlinico San Matteo - U.O. di Cardiologia

Pavia, Italy
Freeman Hospital

Newcastle, United Kingdom
Froedtert Hospital/Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Fundación Abood Shaio

Bogotá, Colombia
Fundación Neumologica Colombiana

Bogotá, Colombia
Golden Jubilee National Hospital, Agamemnon Street

Clydebank, United Kingdom
Hammersmith Hospital

London, United Kingdom
Hospital Clinic I Provincial

Barcelona, Spain
Hospital Costa del Sol

Marbella, Spain
Hospital Privado Centro Medico de Cordóba S.A.

Córdoba, Argentina
Hospital Provincial Dr. José María Cullen

Santa Fe, Argentina
Hospital Universitario 12 De Octubre

Madrid, Spain
Hospital Universitario Dr. José Eleuterio González Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas

Monterrey, Mexico
Hospital Universitario Marques de Valdecilla

Santander, Spain
Hospital Universitario Puerta De Hierro Majadahonda

Majadahonda, Spain
Hospital Universitario Son Espases

Palma de Mallorca, Spain
Hospital Universitario Virgen del Rocío

Seville, Spain
Hospital Universitario de Toledo

Toledo, Spain
Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, Lithuania
Houston Methodist Outpatient Center

Houston, Texas, 77030, United States
Hôpital Erasme

Anderlecht, Belgium
Hôpital Pasteur

Nice, France
Hôpitaux Universitaires de Strasbourg

Strasbourg, France
INTEGRIS Cardiovascular Physicians, LLC

Oklahoma City, Oklahoma, 73112, United States
IRCCS Azienda Ospedaliero Universitaria Di Bologna Policlinico 5 Orsola Malpighi - U.O.C. Cardiologia

Bologna, Italy
Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States
Institut Coeur Poumon

Lille, France
Institut Klinicke a Experimentalni Mediciny

Prague, Czechia
Institute for Cardiovascular Diseases "Dedinje" Clinic for Cardiology

Belgrade, Serbia
Instituto Cardiovascular de Buenos Aires

Buenos Aires, Argentina
Instituto Medico Rio Cuarto

Río Cuarto, Argentina
Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

Belo Horizonte, Brazil
Instituto de Cardiologia de Corrientes Juana Francisca Cabral

Corrientes, Argentina
Instituto de Investigaciones Clinicas Quilmes

Quilmes, Argentina
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil
Instituto nacional de Cardiologia Ignacio Chavez

Mexico City, Mexico
Intermountain Medical Center

Murray, Utah, 84107, United States
Irmandade da Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Brazil
Keck Medical Center of USC

Los Angeles, California, 90033, United States
Keio University Hospital

Shinjuku-Ku, Japan
King Fahad Medical City

Riyadh, Saudi Arabia
King Faisal Specialist Hospital and Research Center

Riyadh, Saudi Arabia
Klinikum Wurzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin

Würzburg, Germany
Klinikum der LMU Medizinische Klinik und Poliklinik V

München, Germany
Krakowski Szpital Specjalistyczny Im. Św. Jana Pawła II Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego

Krakow, Poland
Krankenhaus Neuwittelsbach

Munich, Germany
Kurume University Hospital

Kurume, Japan
Kyorin University Hospital

Tokyo, Japan
Kyushu University Hospital

Fukuoka, Japan
Lady Davis Carmel Medical Center

Haifa, 3436212, Israel
London Health Science Centre - Victoria Hospital

London, Ontario, N6A 5W9, Canada
M Health Fairview University of Minnesota Medical Center - East Bank

Minneapolis, Minnesota, 55455, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Mater Misericordiae University Hospital, Respiratory Department

Dublin, Ireland
Mayo Clinic

Jacksonville, Florida, 32224, United States
Medical University of South Carolina - Nexus Research Center

Charleston, South Carolina, 29425, United States
Mediprax Centrum S.R.L

Cluj-Napoca, Romania
Meir Medical Center

Kfar Saba, 4428164, Israel
NHO Okayama Medical Center

Okayama, Japan
NYU Langone Health

New York, New York, 10016, United States
Nagoya University Hospital

Nagoya, Japan
National Cerebral and Cardiovascular Center

Suita, Japan
National Heart Centre Singapore

Singapore, Singapore
National University Heart Centre Singapore

Singapore, Singapore
Nepean Hospital

Kingswood, Australia
Northside Hospital Laboratory - Atlanta

Atlanta, Georgia, 30342, United States
Norton Hospital

Louisville, Kentucky, 40202, United States
Núcleo de Gestão de Pesquisa/Hospital São Paulo - SPDM/UNIFESP

São Paulo, Brazil
Onassis Cardiac Surgery Center

Kallithea, Greece
Oregon Health & Science University

Portland, Oregon, 97239, United States
Pauls Stradins Clinical University Hospital

Riga, Latvia
Peter Lougheed Center

Calgary, Canada
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead

Atlanta, Georgia, 30309, United States
Pulmonary Associates of Richmond, Inc.

Richmond, Virginia, 23230, United States
Rabin Medical Center

Petah Tikva, Israel
Religious Hospital Linz GmbH

Linz, Austria
Rhode Island Hospital

Providence, Rhode Island, 02903, United States
Rigshospitalet, Department of Cardiology

Copenhagen, Denmark
Royal Brompton Hospital, Pulmonary Hypertension Service, Sydney Street

London, United Kingdom
Royal Free Hospital

London, United Kingdom
Royal Hobart Hospital

Hobart, Australia
Royal Papworth Hospital NHS Foundation Trust

Cambridge, United Kingdom
Samsung Medical Center

Seoul, South Korea
Sanatorio Parque S.A.

Rosario, Argentina
Seoul National University Hospital

Seoul, South Korea
Severance Hospital, Yonsei University Health System Seoul

Seoul, South Korea
Sheffield Clinical Research Facility, Royal Hallamshire Hospital

Sheffield, United Kingdom
St Vincent's Hospital

Melbourne, Victoria, 3065, Australia
Stanford Healthcare

Stanford, California, 94305, United States
Targu-Mures Emergency Clinical County Hospital, Internal Medicine II

Târgu Mureş, Romania
Tel Aviv Sourasky Medical Center

Tel Aviv, Israel
Temple Heart and Vascular Institute (Outpatient Clinic)

Philadelphia, Pennsylvania, 19140, United States
The Catholic University of Korea, Seoul St. Mary´s Hospital

Seoul, South Korea
The Chaim Sheba Medical Center

Ramat Gan, Israel
The George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States
The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie

Heidelberg, Germany
Tufts Medical Center

Boston, Massachusetts, 02111, United States
UC Davis Health

Sacramento, California, 95817, United States
UI Health Hospital

Chicago, Illinois, 60612, United States
UNC Hospitals

Chapel Hill, North Carolina, 27514, United States
UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States
UT Southwestern Medical Center

Dallas, Texas, 75390, United States
Uniao Brasileira de Educaçao e Assistência Hospital São Lucas da PUCRS

Porto Alegre, Brazil
Unidad de Investigacion Clinica en Medicina, S.C.

Monterrey, Mexico
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
University Clinical Centre of Serbia, Cardiology Clinic

Belgrade, Serbia
University Health Network

Toronto, Canada
University Hospitals of Leuven (Campus Gasthuisberg)

Leuven, Belgium
University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States
University of California, Irvine Medical Center

Orange, California, 92868, United States
University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States
University of Florida Clinical Research Center

Gainesville, Florida, 32610, United States
University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States
University of Kansas Medical Center

Kansas City, Kansas, 66160, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Missouri

Columbia, Missouri, 65212, 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
University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada
University of Rochester Medical Center

Rochester, New York, 14642, United States
University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States
University of Tokyo Hospital

Tokyo, Japan
University of Utah Hospital

Salt Lake City, Utah, 84132, United States
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
Valley Advanced Lung Diseases Institute

Fresno, California, 93711, United States
Všeobecná fakultní nemocnice v Praze Il. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hypertenzi

Prague, Czechia
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Wesley Research Institute

Auchenflower, Australia
Winchester Center for Lung Disease

New Haven, Connecticut, 06519, United States
Zentrum fur Pulmona le Hypertonie, Klini k Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternlstische lntensiv medizin), Herzzentrum der Universitat zu Koln

Cologne, Germany

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