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

May 18, 2026 updated by: GB002, Inc.

An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)

This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

316

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Cardiología Palermo
      • Corrientes, Argentina
        • Instituto de Cardiologia de Corrientes Juana Francisca Cabral
      • Quilmes, Argentina
        • Instuto de Investigacion Clinicas Quilmes
      • Río Cuarto, Argentina
        • Instituto Medico Río Cuarto
      • Santa Fe, Argentina
        • Hospital Provincial Dr. José María Cullen
  • Australia
      • Auchenflower, Australia
        • Wesley Research Institute
      • Fitzroy, Australia
        • St Vincent's Hospital (Melbourne)
      • Hobart, Australia
        • Royal Hobart Hospital
  • Belgium
      • Leuven, Belgium
        • University Hospitals of Leuven (Campus Gasthuisberg)
  • Brazil
      • Belo Horizonte, Brazil
        • Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
      • Blumenau, Brazil
        • Complexo de Prevencao, Diagnostico, Terapia e Reabilitacao Respiratoria - Hospital Dia di Pulmao
      • Porto Alegre, Brazil
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
      • Porto Alegre, Brazil
        • Uniao Brasileira de Educaçao e Assistência Hospital São Lucas da PUCRS
      • São Paulo, 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
  • Canada
      • Calgary, Canada
        • Peter Lougheed Center
      • London, Canada
        • London Health Sciences Centre - Victoria Hospital
      • Ottawa, Canada
        • University of Ottawa Heart Institute
      • Toronto, Canada
        • University Health Network, Toronto General Hospital
  • Chile
      • Santiago, Chile
        • Centro de Investigacion Clinica UC-CICUC
      • Santiago, Chile
        • Enroll SpA
  • Colombia
      • Bogotá, Colombia
        • Fundación Abood Shaio
      • Bogotá, Colombia
        • Fundación Neumologica Colombiana
  • Czechia
      • Prague, Czechia
        • Institut klinicke a experimentalni mediciny Klinika kardiologie Ambulance plicni hypertenze
      • Prague, Czechia
        • Všeobecná fakultní nemocnice v Praze ll. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hvpertenzi
  • Denmark
      • Aarhus, Denmark
        • Aarhus Universiteshospital
  • France
      • Le Kremlin-Bicêtre, France
        • CHU Bicetre, Service de Pneumologie et Reanimation Respiratorie
      • Lille, France
        • Centre Hospitalier REgional Universitaire de Lille Hopital Cardiologique - Institut Coeur Poumon Service de Cardiologie
      • Nice, France
        • CHU de Nice - Hopital Pasteur
      • Poitiers, France
        • CHU de Poitiers
  • Germany
      • Cologne, Germany
        • Zentrum fur Pulmonale Hypertonie, Klinik Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternistische lntensivmedizin), Herzzentrum der Universitat zu Koln
      • Giessen, Germany
        • Universitatsklinikum Giessen und Marburg GmbH Zentrum fur lnnere Medizin, Med. Klinik und Poliklinik II Studienambulanz fur Pulmonale Hypertonie
      • Heidelberg, Germany
        • Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie
      • Munich, Germany
        • Klinikum der LMU Medizinische Klinik und Poliklinik V
      • München, Germany
        • Krankenhaus Neuwittelsbach
      • Würzburg, Germany
        • Klinikum Wurzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin
  • Greece
      • Athens, Greece
        • ATTIKON University Hospital, 2nd Critical Care Department
      • Athens, Greece
        • "Evangelismos" General Hospital of Athens, 1st Department of Clinical Care and Pulmonary Hypertension Clinic
      • Kallithea, Greece
        • Onassis Cardiac Surgery Center, Non-Invasive Cardiology Department
      • Thessaloniki, Greece
        • AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic
  • Ireland
      • Dublin, Ireland
        • Mater Misericordiae University Hospital
  • Israel
      • Haifa, Israel
        • Lady Davis Carmel Medical Center
  • Italy
      • Bologna, Italy
        • IRCCS Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - UOC Cardiologia
      • Naples, Italy
        • Azienda Ospedaliera Dei Colli - Ospedale Monaldi
      • Pavia, Italy
        • Fondazione IRCCS Policlinico San matteo
      • Roma, Italy
        • A.O.U. Policlinico Umberto I
  • Japan
      • Bunkyō City, Japan
        • University of Tokyo Hospital
      • Fukuoka, Japan
        • Kyushu University Hospital
      • Mitaka, Japan
        • Kyorin University Hospital
      • Nagoya, Japan
        • Nagoya University Hospital
      • Okayama, Japan
        • NHO Okayama Medical Center
      • Shinjuku-Ku, Japan
        • Keio University Hospital
      • Suita, Japan
        • National Cerebral and Cardiovascular Center
  • Latvia
      • Riga, Latvia
        • Pauls Stradins Clinical University Hospital
  • Lithuania
      • Kaunas, Lithuania
        • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
  • Mexico
      • Mexico City, Mexico
        • Instituto Nacional de Cardiologia Ignacio Chavez
      • Monterrey, Mexico
        • Unidad de Investigación Clínica en Medicina, S.C.
  • Netherlands
      • Amsterdam, Netherlands
        • Amsterdam UMC, location VU mc
  • Poland
      • Krakow, Poland
        • Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn z Pododdzialem Intensywnego Nadzoru Kardiologicznego
      • Otwock, Poland
        • Europejskie Centrum Zdrowia Otwock Sp.zo.o. Szpital im. Fryderyka Chopina Oddzial Kardiologiczny
  • Portugal
      • Lisbon, Portugal
        • Unidade Local de Saude de Santa Maria, E.P.E. Hospital Pulido Valente
      • Porto, Portugal
        • Unidade Local de Saude de Santo Antonio, E.P.E. Hospital de Santo Antonio
  • Romania
      • Bucharest, Romania
        • Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Cardiology 2
      • Cluj-Napoca, Romania
        • "Niculae Stancioiu" Emergency Heart Institute for Cardiovascular Diseases, Cardiology 1 Department
  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • King Faisal Specialist Hospital and Research Center
      • Riyadh, Saudi Arabia
        • King Fahad Medical City
  • Serbia
      • Belgrade, Serbia
        • University Clinical Centre of Serbia, Cardiology Clinic
  • Singapore
      • Singapore, Singapore
        • National Heart Centre Singapore
  • South Korea
      • Seoul, South Korea
        • Asan Medical Center
      • Seoul, South Korea
        • Samsung Medical Center
      • Seoul, South Korea
        • Seoul National University Hospital
  • Spain
      • Barcelona, Spain
        • Hospital Clinic I Provincial
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Santander, Spain
        • Hospital Universitario Marques de Valdecilla
      • Seville, Spain
        • Hospital Universitario Virgen del Rocío
      • Toledo, Spain
        • Hospital Universitario de Toledo
  • United Kingdom
      • Cambridge, United Kingdom
        • Royal Papworth Hospital NHS Foundation Trust
      • Clydebank, United Kingdom
        • Golden Jubilee National Hospital
      • London, United Kingdom
        • Hammersmith Hospital
      • London, United Kingdom
        • Royal Free Hospital, Clinical Research Facility
      • Newcastle, United Kingdom
        • Freeman Hospital
      • Sheffield, United Kingdom
        • Royal Hallamshire Hospital
  • United States
    • California
      • Fresno, California, United States, 93720
        • Valley Advanced Lung Diseases Institute
      • Los Angeles, California, United States, 90073
        • Department of Veterans Affairs Greater Los Angeles Healthcare System
      • Sacramento, California, United States, 95817
        • UC Davis Health Medical Center
      • Stanford, California, United States, 94305
        • Stanford Healthcare
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida Health
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • The Emory Clinic
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital - Atlanta
      • Atlanta, Georgia, United States, 30309
        • Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
    • Illinois
      • Chicago, Illinois, United States, 60612
        • UI Health Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Pulmonary Specialists
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Health Sciences Center
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • UNC Hospitals
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • INTEGRIS Cardiovascular Physicians
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple Heart and Vascular Institute (Outpatient Clinic)
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina - Nexus Research Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • CHI St. Luke's Health Baylor College of Medicine Medical Center
      • Houston, Texas, United States, 77030
        • Houston Methodist Outpatient Center
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Campus
      • Richmond, Virginia, United States, 23230
        • Pulmonary Associates of Richmond, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.
  2. Evidence of an informed consent document, signed and dated by the subject, indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures.
  3. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  4. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at enrollment visit before first administration of Investigational Product (IP) in this study.
  5. WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of IP.
  6. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP.

Exclusion Criteria:

  1. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib administration, unless associated with an ongoing AE and discussed with the Sponsor's medical monitor (MM) (or designee).
  2. Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Seralutinib 90 mg
Seralutinib inhaled orally twice per day (BID)
Drug: Seralutinib
Capsule containing seralutinib
Device: Gereic Dry Powder Inhaler
Generic dry powder inhaler for seralutinib delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: From baseline to end of study (up to 48 months or availability of commercial product)
From baseline to end of study (up to 48 months or availability of commercial product)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in distance achieved on the Six-Minute Walk Test (6MWT)
Time Frame: Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)
Δ6MWT from Baseline to End of Study
Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)
Changes in NT-proBNP
Time Frame: Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)
Change in NT-proBNP from Baseline to End of Study
Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GB002, Inc.

Investigators

  • Study Director: Richard Aranda, MD, Gossamer Bio Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 19, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GB002-3102
  • 2023-506334-75 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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