Pulmonary Arterial HypertensionPhase 3NCT06274801
Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
A Phase 3 study testing Seralutinib and Gereic Dry Powder Inhaler in people with Pulmonary Arterial Hypertension, run by Gossamer Bio USA, Inc. at 120 sites in 30 countries.
Trial summary
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 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 Gereic Dry Powder Inhaler
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 120 sitesin 30 countries
- Study dates
- 3 Sep 2024to Dec 2026
- Phase
- Phase 3
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
- Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.
- 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.
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- 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.
- 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
- 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).
- Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.
Trial locations and contacts
120 sites in 30 countries. Contact the study team or a site near you to ask about taking part.
120 sites in 30 countries
United States33 sites, 29 recruiting
- Completed
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Recruiting
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta, Georgia, 30309
- Recruiting
The Emory Clinic
Atlanta, Georgia, 30322
- Recruiting
Northside Hospital - Atlanta
Atlanta, Georgia, 30342
- Completed
UNC Hospitals
Chapel Hill, North Carolina, 27514
- Recruiting
Medical University of South Carolina - Nexus Research Center
Charleston, South Carolina, 29425
- Recruiting
UI Health Hospital
Chicago, Illinois, 60612
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
- Recruiting
Valley Advanced Lung Diseases Institute
Fresno, California, 93720
- Recruiting
University of Florida Health
Gainesville, Florida, 32610
- Recruiting
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston, Texas, 77030
- Completed
Houston Methodist Outpatient Center
Houston, Texas, 77030
- Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
- Recruiting
Department of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California, 90073
- Recruiting
Norton Pulmonary Specialists
Louisville, Kentucky, 40202
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
- Recruiting
NYU Langone Health
New York, New York, 10016
- Active, not recruiting
INTEGRIS Cardiovascular Physicians
Oklahoma City, Oklahoma, 73112
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
- Recruiting
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
Temple Heart and Vascular Institute (Outpatient Clinic)
Philadelphia, Pennsylvania, 19140
- Recruiting
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
- Recruiting
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23230
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
- Recruiting
UC Davis Health Medical Center
Sacramento, California, 95817
- Recruiting
University of Utah Hospital
Salt Lake City, Utah, 84132
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
- Recruiting
Stanford Healthcare
Stanford, California, 94305
Germany7 sites, 6 recruiting
- Recruiting
Zentrum fur Pulmonale Hypertonie, Klinik Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternistische lntensivmedizin), Herzzentrum der Universitat zu Koln
Cologne
- Withdrawn
Universitätsklinikum Dresden, Medizinische Klinik I / Pneumologisches Studiensekretariat
Dresden
- Recruiting
Universitatsklinikum Giessen und Marburg GmbH Zentrum fur lnnere Medizin, Med. Klinik und Poliklinik II Studienambulanz fur Pulmonale Hypertonie
Giessen
- Recruiting
Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie
Heidelberg
- Recruiting
Krankenhaus Neuwittelsbach
München
- Recruiting
Klinikum der LMU Medizinische Klinik und Poliklinik V
Munich
- Recruiting
Klinikum Würzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin
Würzburg
Japan7 sites, 7 recruiting
- Recruiting
University of Tokyo Hospital
Bunkyō City
- Recruiting
Kyushu University Hospital
Fukuoka
- Recruiting
Kyorin University Hospital
Mitaka
- Recruiting
Nagoya University Hospital
Nagoya
- Recruiting
NHO Okayama Medical Center
Okayama
- Recruiting
Keio University Hospital
Shinjuku-Ku
- Recruiting
National Cerebral and Cardiovascular Center
Suita
Brazil6 sites, 5 recruiting
- Recruiting
Instituto das Pequenas Missionarias de Maria Imaculada - Hospital Madre Teresa
Belo Horizonte
- Recruiting
Complexo de Prevencao, Diagnostico, Terapia e Reabilitacao Respiratoria - Hospital Dia di Pulmao
Blumenau
- Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre
- Recruiting
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre
- Recruiting
Instituto do Coracao do Hospital das Clinicas da Faculdade de medicina da Universidade de Sao Paulo
São Paulo
- Active, not recruiting
Nucleo de Gestao de Pesquisa/Hospital Sao Paulo - SPDM/UNIFESP
São Paulo
United Kingdom6 sites, 5 recruiting
- Recruiting
Royal Papworth Hospital NHS Foundation Trust
Cambridge
- Recruiting
Golden Jubilee National Hospital
Clydebank
- Completed
Hammersmith Hospital
London
- Recruiting
Royal Free Hospital, Clinical Research Facility
London
- Recruiting
Freeman Hospital
Newcastle
- Recruiting
Royal Hallamshire Hospital
Sheffield
Argentina5 sites, 5 recruiting
- Recruiting
Cardiologia Palermo
Buenos Aires
- Recruiting
Instituto de Cardiologia de Corrientes Juana Francisca Cabral
Corrientes
- Recruiting
Instuto de Investigacion Clinicas Quilmes
Quilmes
- Recruiting
Instituto Medico Rio Cuarto
Río Cuarto
- Recruiting
Hospital Provincial Dr. Jose Maria Cullen
Santa Fe
Spain5 sites, 2 recruiting
- Completed
Hospital Clinic I Provincial
Barcelona
- Recruiting
Hospital Universitario 12 De Octubre
Madrid
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander
- Completed
Hospital Universitario Virgen del Rocio
Seville
- Completed
Hospital Universitario de Toledo
Toledo
Canada4 sites, 2 recruiting
- Recruiting
Peter Lougheed Center
Calgary
- Recruiting
London Health Sciences Centre - Victoria Hospital
London
- Active, not recruiting
University of Ottawa Heart Institute
Ottawa
- Completed
University Health Network, Toronto General Hospital
Toronto
France4 sites, 3 recruiting
- Recruiting
CHU Bicetre, Service de Pneumologie et Reanimation Respiratorie
Le Kremlin-Bicêtre
- Recruiting
Centre Hospitalier REgional Universitaire de Lille Hopital Cardiologique - Institut Coeur Poumon Service de Cardiologie
Lille
- Completed
CHU de Nice - Hopital Pasteur
Nice
- Recruiting
CHU de Poitiers
Poitiers
Greece4 sites, 3 recruiting
- Recruiting
"Evangelismos" General Hospital of Athens, 1st Department of Clinical Care and Pulmonary Hypertension Clinic
Athens
- Recruiting
ATTIKON University Hospital, 2nd Critical Care Department
Athens
- Completed
Onassis Cardiac Surgery Center, Non-Invasive Cardiology Department
Kallithea
- Recruiting
AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic
Thessaloniki
Italy4 sites, 4 recruiting
- Recruiting
IRCCS Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - UOC Cardiologia
Bologna
- Recruiting
Azienda Ospedaliera Dei Colli - Ospedale Monaldi
Naples
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia
- Recruiting
A.O.U. Policlinico Umberto I
Roma
South Korea4 sites, 3 recruiting
- Recruiting
Asan Medical Center
Seoul
- Recruiting
Samsung Medical Center
Seoul
- Recruiting
Seoul National University Hospital
Seoul
- Withdrawn
Severance Hospital, Yonsei University Health System
Seoul
Australia3 sites, 3 recruiting
- Recruiting
Pulmonary Hypertension Research Queensland
Auchenflower
- Recruiting
St Vincent's Hospital (Melbourne)
Fitzroy
- Recruiting
Royal Hobart Hospital
Hobart
Belgium2 sites, 1 recruiting
- Withdrawn
Hopital Erasme
Anderlecht
- Recruiting
University Hospitals of Leuven (Campus Gasthuisberg)
Leuven
Chile2 sites, 2 recruiting
- Recruiting
Centro de Investigacion Clinica UC-CICUC
Santiago
- Recruiting
Enroll SpA
Santiago
Colombia2 sites, 2 recruiting
- Recruiting
Fundacion Abood Shaio
Bogotá
- Recruiting
Fundacion Neumologica Colombiana
Bogotá
Czechia2 sites, 2 recruiting
- Recruiting
Institut klinicke a experimentalni mediciny Klinika kardiologie Ambulance plicni hypertenze
Prague
- Recruiting
Všeobecná fakultní nemocnice v Praze ll. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hvpertenzi
Prague
Mexico2 sites, 2 recruiting
- Recruiting
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City
- Recruiting
Unidad de Investigacion Clinica en Medicina, S.C.
Monterrey
Netherlands2 sites
- Completed
Amsterdam UMC, location VU mc
Amsterdam
- Withdrawn
Erasmus MC
Rotterdam
Poland2 sites, 2 recruiting
- Recruiting
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn z Pododdzialem Intensywnego Nadzoru Kardiologicznego
Krakow
- Recruiting
Europejskie Centrum Zdrowia Otwock Sp.zo.o. Szpital im. Fryderyka Chopina Oddzial Kardiologiczny
Otwock
Portugal2 sites, 2 recruiting
- Recruiting
Unidade Local de Saude de Santa Maria, E.P.E. Hospital Pulido Valente
Lisbon
- Recruiting
Unidade Local de Saude de Santo Antonio, E.P.E. Hospital de Santo Antonio
Porto
Romania2 sites, 2 recruiting
- Recruiting
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Cardiology 2
Bucharest
- Recruiting
"Niculae Stancioiu" Emergency Heart Institute for Cardiovascular Diseases, Cardiology 1 Department
Cluj-Napoca
Saudi Arabia2 sites
- Completed
King Fahad Medical City
Riyadh
- Completed
King Faisal Specialist Hospital and Research Center
Riyadh
Singapore2 sites, 1 recruiting
- Recruiting
National Heart Centre Singapore
Singapore
- Withdrawn
National University Heart Centre
Singapore
Ireland1 site, 1 recruiting
- Recruiting
Mater Misericordiae University Hospital
Dublin
Latvia1 site, 1 recruiting
- Recruiting
Pauls Stradins Clinical University Hospital
Riga
Lithuania1 site, 1 recruiting
- Recruiting
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas
Serbia1 site, 1 recruiting
- Recruiting
University Clinical Centre of Serbia, Cardiology Clinic
Belgrade
About this study
Official title: 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
Read the detailed description
The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Seralutinib, Gereic Dry Powder Inhaler
- Keywords
- seralutinib, GB002, PROSERA, PROSERA-EXT
- 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.
SeralutinibDrug
Capsule containing seralutinib
Gereic Dry Powder InhalerDevice
Generic dry powder inhaler for seralutinib delivery
| Study group | Role | What they receive |
|---|---|---|
| Seralutinib 90 mg | Experimental | Seralutinib inhaled orally twice per day (BID) Receives: Drug: Seralutinib; Device: Gereic Dry Powder Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Measured: From baseline to end of study (up to 48 months or availability of commercial product)
Secondary outcomes (2)
Changes in distance achieved on the Six-Minute Walk Test (6MWT)
Δ6MWT from Baseline to End of Study
Measured: 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
Change in NT-proBNP from Baseline to End of Study
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start3 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gossamer Bio USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Aranda, MD, Study director, Gossamer Bio USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274801
- Sponsor's protocol ID
- GB002-3102
- Other IDs
- 2023-506334-75, 2023
- Status last verified
- Jul 2026
- First submitted
- 19 Jan 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No