Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Device: Gereic Dry Powder Inhaler
- Registration Number
- NCT06274801
- Lead Sponsor
- GB002, Inc.
- Brief 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
- Detailed Description
The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Seralutinib 90 mg Seralutinib Seralutinib inhaled orally twice per day (BID) Seralutinib 90 mg Gereic Dry Powder Inhaler Seralutinib inhaled orally twice per day (BID)
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs) From baseline to end of study (up to 48 months or availability of commercial product)
- Secondary Outcome Measures
Name Time Method Changes in distance achieved on the Six-Minute Walk Test (6MWT) 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
Changes in NT-proBNP 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
Trial Locations
- Locations (49)
Aarhus Universiteshospital
🇩🇰Aarhus, Denmark
National University Heart Centre
🇸🇬Singapore, Singapore
Hospital Clinic I Provincial
🇪🇸Barcelona, Spain
Hospital Universitario 12 De Octubre
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Lady Davis Carmel Medical Center
🇮🇱Haifa, Israel
University of New Mexico Health Sciences Center
🇺🇸Albuquerque, New Mexico, United States
Enroll SpA
🇨🇱Santiago, Chile
CHU de Poitiers
🇫🇷Poitiers, France
Europejskie Centrum Zdrowia Otwock Sp.zo.o. Szpital im. Fryderyka Chopina Oddzial Kardiologiczny
🇵🇱Otwock, Poland
Department of Veterans Affairs Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
🇺🇸Atlanta, Georgia, United States
The Emory Clinic
🇺🇸Atlanta, Georgia, United States
Northside Hospital - Atlanta
🇺🇸Atlanta, Georgia, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Norton Pulmonary Specialists
🇺🇸Louisville, Kentucky, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Houston Methodist Outpatient Center
🇺🇸Houston, Texas, United States
Inova Fairfax Medical Campus
🇺🇸Falls Church, Virginia, United States
Pulmonary Associates of Richmond, Inc.
🇺🇸Richmond, Virginia, United States
Cardiologia Palermo
🇦🇷Buenos Aires, Argentina
Instituto de Cardiologia de Corrientes Juana Francisca Cabral
🇦🇷Corrientes, Argentina
Instituto Medico Rio Cuarto
🇦🇷Río Cuarto, Argentina
Hospital Provincial Dr. Jose Maria Cullen
🇦🇷Santa Fe, Argentina
Wesley Research Institute
🇦🇺Auchenflower, Australia
St Vincent's Hospital (Melbourne)
🇦🇺Fitzroy, Australia
Hopital Erasme
🇧🇪Anderlecht, Belgium
Institut klinicke a experimentalni mediciny Klinika kardiologie Ambulance plicni hypertenze
🇨🇿Praha, Czechia
CHU Bicetre, Service de Pneumologie et Reanimation Respiratorie
🇫🇷Le Kremlin-Bicêtre, France
CHU de Nice - Hopital Pasteur
🇫🇷Nice, France
Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie
🇩🇪Heidelberg, Germany
Klinikum Würzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin
🇩🇪Würzburg, Germany
ATTIKON University Hospital, 2nd Critical Care Department
🇬🇷Athens, Greece
AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic
🇬🇷Thessaloníki, Greece
IRCCS Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - UOC Cardiologia
🇮🇹Bologna, Italy
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
A.O.U. Policlinico Umberto I
🇮🇹Roma, Italy
National Cerebral and Cardiovascular Center
🇯🇵Suita, Japan
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
Hospital of Lithuanian University of Health Sciences Kauno klinikos
🇱🇹Kaunas, Lithuania
Unidad de Investigacion Clinica en Medicina, S.C.
🇲🇽Monterrey, Mexico
Erasmus MC
🇳🇱Rotterdam, Netherlands
Unidade Local de Saude de Santo Antonio, E.P.E. Hospital de Santo Antonio
🇵🇹Porto, Portugal
University Clinical Centre of Serbia, Cardiology Clinic
🇷🇸Belgrade, Serbia
National Heart Centre Singapore
🇸🇬Singapore, Singapore
Royal Papworth Hospital NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Golden Jubilee National Hospital
🇬🇧Clydebank, United Kingdom