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AzTrials

Pulmonary Arterial HypertensionPhase 3NCT05934526

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

A Phase 3 study testing Seralutinib and Generic Dry Powder Inhaler in people with Pulmonary Arterial Hypertension, run by GB002, Inc. at 166 sites in 31 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Seralutinib and Generic Dry Powder Inhaler
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
390 participants
Where
166 sitesin 31 countries
Study dates
28 Dec 2023to 22 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult subjects aged 18 to 75 years.
  • Body mass index (BMI) ≥ 15 kg/m^2 and ≤ 40 kg/m^2.
  • Diagnosis of PAH classified by one of the following:
  • Idiopathic PAH (IPAH) or heritable PAH (HPAH).
  • PAH associated with connective tissue disease (CTD-APAH); PAH associated with anorexigen or PAH associated with methamphetamine use.
  • Congenital heart disease with simple systemic to pulmonary shunt at least 1 year after surgical repair.
Show all 20Show fewer
  • 6MWDs ≥ 150 meters and ≤ 475 meters during Screening prior to randomization.
  • WHO FC II or III.
  • 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.
  • 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.
  • Mean pulmonary arterial pressure (mPAP) > 20 mmHg (at rest), AND
  • Pulmonary vascular resistance (PVR) ≥ 400 dyne·s/cm^5, AND
  • Pulmonary capillary wedge pressure (PCWP) or left ventricle end-diastolic pressure (LVEDP) ≤ 15 mmHg.
  • Treatment with at least one allowed background PAH disease-specific medication prior to Screening.
  • 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.
  • 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).
  • Pulmonary function tests (PFTs) at Screening or completed no more than 12 weeks prior to Screening.
  • Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and on Day 1 before first administration of Investigational Product (IP).
  • 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.

Who cannot join

  • Evidence of chronic thromboembolic disease or acute pulmonary embolism.
  • Uncontrolled systemic hypertension as evidenced by systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg.
  • Systolic blood pressure < 90 mm Hg during Screening.
  • WHO Pulmonary Hypertension Group 2 - 5.
  • Human immunodeficiency virus (HIV)-associated PAH, schistosomiasis associated PAH, PAH associated with portal hypertension, or pulmonary veno-occlusive disease (PVOD).
  • Recent history of left-sided heart disease and/or clinically significant cardiac disease within 48 weeks of Screening.
Show all 39Show fewer
  • Left ventricular ejection fraction (LVEF) ≤ 50% within 24 weeks of Screening.
  • Hemodynamically significant valvular heart disease or uncontrolled symptomatic coronary disease.
  • History of atrial septostomy.
  • Uncontrolled atrial fibrillation or paroxysmal atrial fibrillation.
  • Untreated severe obstructive sleep apnea.
  • 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.
  • 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).
  • Any musculoskeletal disease, injury, or any other disease that limits evaluation of 6MWT.
  • Initiation of an exercise program for cardiopulmonary rehabilitation within 12 weeks prior to Screening or planned during the study.
  • Pregnant or nursing or intends to become pregnant during the duration of the study.
  • Body weight < 37 kg at Screening.
  • Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m^2 Hemoglobin (Hgb) concentration < 8.5 g/dL at Screening.
  • Evidence of active or latent Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C, or tuberculosis (TB) infection at Screening.
  • Prior/concurrent treatment with tyrosine kinase inhibitors or activin signaling inhibitors:
  • Tyrosine kinase inhibitors, other than Janus kinase inhibitors approved for systemic autoimmune rheumatic diseases, within 12 weeks prior to Screening.
  • Activin signaling inhibitors within 5 half-lives prior to Screening.
  • Requirement of IV inotropes (ie, levosimendan, dopamine, dobutamine, milrinone, norepinephrine) or IV diuretics for more than 24 hours within 4 weeks prior to Screening.
  • 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:
  • 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.
  • History of central nervous system pathology.
  • History of clinically significant (massive) hemoptysis.
  • If on warfarin/other vitamin K antagonist, uncontrolled International normalized ratio (eg, INR > 3) as assessed.
  • Platelet count < 150 x 10^9/L at Screening.
  • Concomitant use of antiplatelet agents.
  • CTD-APAH
  • Concomitant use of sotatercept.
  • Prior participation in seralutinib studies and/or prior treatment with seralutinib.
  • 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.
  • Current use of inhaled tobacco- or nicotine-containing products (including e-vapor products) and/or inhaled marijuana.
  • Current alcohol use disorder based on the opinion of the Investigator, and/or a positive test for drugs of abuse.
  • Subjects with a history of severe milk protein allergy or known intolerance to lactose.
  • QT interval corrected for heart rate using Fridericia's formula (QTcF) of > 500 msec.
  • 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.

Trial locations and contacts

166 sites in 31 countries.

166 sites in 31 countries

United States50 sites

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87131

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead

    Atlanta, Georgia, 30309

  • Emory University

    Atlanta, Georgia, 30322

  • Northside Hospital Laboratory - Atlanta

    Atlanta, Georgia, 30342

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • UNC Hospitals

    Chapel Hill, North Carolina, 27514

  • Medical University of South Carolina - Nexus Research Center

    Charleston, South Carolina, 29425

  • UI Health Hospital

    Chicago, Illinois, 60612

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • University of Missouri

    Columbia, Missouri, 65212

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke University Medical Center - Duke South

    Durham, North Carolina, 27710

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

  • Valley Advanced Lung Diseases Institute

    Fresno, California, 93711

  • University of Florida Clinical Research Center

    Gainesville, Florida, 32610

  • CHI St. Luke's Health Baylor College of Medicine Medical Center

    Houston, Texas, 77030

  • Houston Methodist Outpatient Center

    Houston, Texas, 77030

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Keck Medical Center of USC

    Los Angeles, California, 90033

  • Dept of Veterans Affairs Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • Norton Hospital

    Louisville, Kentucky, 40202

  • Advocate Aurora Health-Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Froedtert Hospital/Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • M Health Fairview University of Minnesota Medical Center - East Bank

    Minneapolis, Minnesota, 55455

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Winchester Center for Lung Disease

    New Haven, Connecticut, 06519

  • NYU Langone Health

    New York, New York, 10016

  • INTEGRIS Cardiovascular Physicians, LLC

    Oklahoma City, Oklahoma, 73112

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of California, Irvine Medical Center

    Orange, California, 92868

  • The Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple Heart and Vascular Institute (Outpatient Clinic)

    Philadelphia, Pennsylvania, 19140

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • Baylor Scott & White Medical Center - The Heart Hospital

    Plano, Texas, 75024

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Pulmonary Associates of Richmond, Inc.

    Richmond, Virginia, 23230

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • UC Davis Health

    Sacramento, California, 95817

  • University of Utah Hospital

    Salt Lake City, Utah, 84132

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford Healthcare

    Stanford, California, 94305

  • The George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

Other trials in United States

Germany10 sites

  • DRK Kliniken Berlin Westend

    Berlin

  • Zentrum fur Pulmona le Hypertonie, Klini k Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternlstische lntensiv medizin), Herzzentrum der Universitat zu Koln

    Cologne

  • Universitatsklinikum Dresden, Medizinische Klinik / Pneumologisches Studiensekretariat

    Dresden

  • Universitatsklinikum Giessen und Marburg GmbH Zentrum fur Innere Medizin, Med. Klinik und Poliklinik II Studienambulanz fur Pulmonale Hypertonie

    Giessen

  • Universitätsklinikum Greifswald Klinik und Poliklinik für Innere Medizin B

    Greifswald

  • Universitätsklinikum Halle (Saale) / Martin-Luther-Universität Halle- Wittenberg, Universitätsklinik und Poliklinik für Innere Medizin I

    Halle

  • Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie

    Heidelberg

  • Klinikum der LMU Medizinische Klinik und Poliklinik V

    München

  • Krankenhaus Neuwittelsbach

    Munich

  • Klinikum Wurzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin

    Würzburg

Other trials in Germany

Argentina8 sites

  • Cardiologia Palermo

    Buenos Aires

  • Instituto Cardiovascular de Buenos Aires

    Buenos Aires

  • Hospital Privado Centro Medico de Cordóba S.A.

    Córdoba

  • Instituto de Cardiologia de Corrientes Juana Francisca Cabral

    Corrientes

  • Instituto de Investigaciones Clinicas Quilmes

    Quilmes

  • Instituto Medico Rio Cuarto

    Río Cuarto

  • Sanatorio Parque S.A.

    Rosario

  • Hospital Provincial Dr. José María Cullen

    Santa Fe

Other trials in Argentina

Japan8 sites

  • Kyushu University Hospital

    Fukuoka

  • Kurume University Hospital

    Kurume

  • Nagoya University Hospital

    Nagoya

  • NHO Okayama Medical Center

    Okayama

  • Keio University Hospital

    Shinjuku-Ku

  • National Cerebral and Cardiovascular Center

    Suita

  • Kyorin University Hospital

    Tokyo

  • University of Tokyo Hospital

    Tokyo

Other trials in Japan

Spain8 sites

  • Hospital Clinic I Provincial

    Barcelona

  • Hospital Universitario 12 De Octubre

    Madrid

  • Hospital Universitario Puerta De Hierro Majadahonda

    Majadahonda

  • Hospital Costa del Sol

    Marbella

  • Hospital Universitario Son Espases

    Palma de Mallorca

  • Hospital Universitario Marques de Valdecilla

    Santander

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Universitario de Toledo

    Toledo

Other trials in Spain

France7 sites

  • CHU Bicêtre

    Le Kremlin-Bicêtre

  • Institut Coeur Poumon

    Lille

  • CHU de Montpellier

    Montpellier

  • Hôpital Pasteur

    Nice

  • CHU de Poitiers

    Poitiers

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg

  • Centre Hospitalier Universitaire - Hôpital d´Adultes de Brabois

    Vandœuvre-lès-Nancy

Other trials in France

United Kingdom7 sites

  • Royal Papworth Hospital NHS Foundation Trust

    Cambridge

  • Golden Jubilee National Hospital, Agamemnon Street

    Clydebank

  • Hammersmith Hospital

    London

  • Royal Brompton Hospital, Pulmonary Hypertension Service, Sydney Street

    London

  • Royal Free Hospital

    London

  • Freeman Hospital

    Newcastle

  • Sheffield Clinical Research Facility, Royal Hallamshire Hospital

    Sheffield

Other trials in United Kingdom

Brazil6 sites

  • Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

    Belo Horizonte

  • Complexo de Prevencao, Diagnostico, Terapia e Reabilitacao Respiratoria - Hospital Dia do Pulmao

    Blumenau

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre

  • Uniao Brasileira de Educaçao e Assistência Hospital São Lucas da PUCRS

    Porto Alegre

  • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo

  • Núcleo de Gestão de Pesquisa/Hospital São Paulo - SPDM/UNIFESP

    São Paulo

Other trials in Brazil

Israel5 sites

  • Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin Medical Center

    Petah Tikva

  • The Chaim Sheba Medical Center

    Ramat Gan

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Italy5 sites

  • IRCCS Azienda Ospedaliero Universitaria Di Bologna Policlinico 5 Orsola Malpighi - U.O.C. Cardiologia

    Bologna

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

    Naples

  • Fondazione IRCCS Policlinico San Matteo - U.O. di Cardiologia

    Pavia

  • Azienda Ospealiero Universitaria Policlinico Umberto I - Dipartamento di Scienze Cliniche Internistiche Anestesiologiche e Cardiovascolari - VIII Padglione

    Rome

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

    Trieste

Other trials in Italy

South Korea5 sites

  • Asan Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital, Yonsei University Health System Seoul

    Seoul

  • The Catholic University of Korea, Seoul St. Mary´s Hospital

    Seoul

Other trials in South Korea

Australia4 sites

  • Wesley Research Institute

    Auchenflower

  • Royal Hobart Hospital

    Hobart

  • Nepean Hospital

    Kingswood

  • St Vincent's Hospital

    Melbourne, Victoria, 3065

Other trials in Australia

Canada4 sites

  • Peter Lougheed Center

    Calgary

  • London Health Science Centre - Victoria Hospital

    London, Ontario, N6A 5W9

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y4W7

  • University Health Network

    Toronto

Other trials in Canada

Greece4 sites

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

    Athens

  • ATTIKON University Hospital, 2nd Critical Care Department

    Athens

  • Onassis Cardiac Surgery Center

    Kallithea

  • AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic

    Thessaloniki

Other trials in Greece

Romania4 sites

  • Emergency Institute of Cardiovascular Diseases "Prof. Dr. C.C. Iliescu" Bucharest, Cardiology 2

    Bucharest

  • "Niculae Stanciolu" Emergency Heart Institute for Cardivascular Diseases

    Cluj-Napoca

  • Mediprax Centrum S.R.L

    Cluj-Napoca

  • Targu-Mures Emergency Clinical County Hospital, Internal Medicine II

    Târgu Mureş

Other trials in Romania

Mexico3 sites

  • Instituto nacional de Cardiologia Ignacio Chavez

    Mexico City

  • Hospital Universitario Dr. José Eleuterio González Centro de Prevención y Rehabilitación de Enfermedades Pulmonares Crónicas

    Monterrey

  • Unidad de Investigacion Clinica en Medicina, S.C.

    Monterrey

Other trials in Mexico

Portugal3 sites

  • Centro Hospitalar e Universitário de Coimbra

    Coimbra

  • Centro Hospitalar Universitário Lisboa Norte, EPE - Hospital Pulido Valente

    Lisbon

  • Centro Hospitalar Universitário de Santo António

    Porto

Other trials in Portugal

Austria2 sites

  • Religious Hospital Linz GmbH

    Linz

  • AKH-Vienna Medical Univesity of Vienna Internal Medicine II-Cardiology

    Vienna

Other trials in Austria

Belgium2 sites

  • Hôpital Erasme

    Anderlecht

  • University Hospitals of Leuven (Campus Gasthuisberg)

    Leuven

Other trials in Belgium

Chile2 sites

  • Enroll SpA

    Santiago, Santiago Metropolitan, 7500587

  • Centro de Investigacion Clinica UC-CICUC

    Santiago

Other trials in Chile

Colombia2 sites

  • Fundación Abood Shaio

    Bogotá

  • Fundación Neumologica Colombiana

    Bogotá

Other trials in Colombia

Czechia2 sites

  • Institut Klinicke a Experimentalni Mediciny

    Prague

  • Všeobecná fakultní nemocnice v Praze Il. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hypertenzi

    Prague

Other trials in Czechia

Denmark2 sites

  • Aarhus Universitetshospital, Department of Cardiology

    Aarhus

  • Rigshospitalet, Department of Cardiology

    Copenhagen

Other trials in Denmark

Netherlands2 sites

  • Amsterdam UMC, location VUmc

    Amsterdam

  • Erasmus MC

    Rotterdam

Other trials in Netherlands

Poland2 sites

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

    Krakow

  • Europejskie Centrum Zdrowia Otwock Sp. z o.o. Szpital irn. Fryderyka Chopina Oddzial Kardiologiczny

    Otwock

Other trials in Poland

Saudi Arabia2 sites

  • King Fahad Medical City

    Riyadh

  • King Faisal Specialist Hospital and Research Center

    Riyadh

Other trials in Saudi Arabia

Serbia2 sites

  • Institute for Cardiovascular Diseases "Dedinje" Clinic for Cardiology

    Belgrade

  • University Clinical Centre of Serbia, Cardiology Clinic

    Belgrade

Other trials in Serbia

Singapore2 sites

  • National Heart Centre Singapore

    Singapore

  • National University Heart Centre Singapore

    Singapore

Other trials in Singapore

Ireland1 site

  • Mater Misericordiae University Hospital, Respiratory Department

    Dublin

Other trials in Ireland

Latvia1 site

  • Pauls Stradins Clinical University Hospital

    Riga

Other trials in Latvia

Lithuania1 site

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas

Other trials in Lithuania

About this study

Official title: A 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)

The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.

Being tested
Placebo, Seralutinib, Generic Dry Powder Inhaler
Keywords
seralutinib, GB002, PROSERA
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Matching capsule containing placebo

  • SeralutinibDrug

    Capsule containing seralutinib

  • Generic Dry Powder InhalerDevice

    Generic dry powder inhaler for seralutinib or placebo delivery

Study groups in NCT05934526
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo inhaled orally twice daily (BID) up to 48 weeks
Receives: Drug: Placebo; Device: Generic Dry Powder Inhaler
Seralutinib 90 mgExperimentalSeralutinib inhaled orally BID up to 48 weeks
Receives: Drug: Seralutinib; Device: Generic Dry Powder Inhaler

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in distance achieved on the six-minute walk test (6MWT), six-minute walk distance (Δ6MWD) from baseline to Week 24

    Measured: Baseline to 24 weeks

Secondary outcomes (9)

  1. Time to first event of Clinical Worsening from first dose of Investigational Product (IP) through end of study

    Measured: Baseline to 48 weeks

  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

    Measured: Baseline to 24 weeks

  3. Change in NT-proBNP from baseline to Week 24

    Measured: Baseline to 24 weeks

  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

    Measured: Baseline to 24 weeks

  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:
    7. Decrease in 6MWD of ≥ 15% on two consecutive tests, performed a minimum of 4 hours but no more than 1 week apart AND
    8. Worsened WHO FC

    Measured: Baseline to 52 weeks

  6. Proportion of subjects who improve from baseline in WHO FC or maintain WHO FC II

    Measured: Baseline to 24 weeks

  7. Change in PAH-SYMPACT™ from baseline to Week 24

    Measured: Baseline to 24 weeks

  8. Change in Euro-QoL - 5 Dimensions - 5 Levels (EQ-5D-5L) from baseline to Week 24

    Measured: Baseline to 24 weeks

  9. Incidence of treatment-emergent adverse events (TEAEs), serious TEAEs (SAEs), and treatment-emergent adverse events of special interest (AESIs)

    Measured: Baseline to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2023
  2. Study start28 Dec 2023
  3. Primary completion27 Nov 2025
  4. Study completion22 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
390 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05934526
Sponsor's protocol ID
GB002-3101
Other IDs
2023-503614-80-00, 2023
Status last verified
Feb 2026
First submitted
28 Jun 2023
Last updated
19 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 40788460

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Seralutinib and Generic Dry Powder Inhaler in people with Pulmonary Arterial Hypertension, run by GB002, Inc. at 166 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in United States, Germany, Argentina, Japan, Spain and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in distance achieved on the six-minute walk test (6MWT), six-minute walk distance (Δ6MWD) from baseline to Week 24 (time frame: Baseline to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05934526, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

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