Clinical trial NCT06274801: Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Keywords: seralutinib
GB002
PROSERA
PROSERA-EXT
Lead sponsor: Gossamer Bio Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: From baseline to end of study (up to 48 months or availability of commercial product)
Secondary outcomes:
measure: Changes in distance achieved on the Six-Minute Walk Test (6MWT)
timeFrame: 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)
measure: Changes in NT-proBNP
timeFrame: 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)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Department of Veterans Affairs Greater Los Angeles Healthcare System
state: California
city: Sacramento
country: United States
facility: UC Davis Health Medical Center
state: California
city: Atlanta
country: United States
facility: Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
state: Georgia
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital - Atlanta
state: Georgia
city: Chicago
country: United States
facility: UI Health Hospital
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Norton Pulmonary Specialists
state: Kentucky
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Houston
country: United States
facility: Houston Methodist Outpatient Center
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond, Inc.
state: Virginia
city: Buenos Aires
country: Argentina
facility: Cardiologia Palermo
city: Corrientes
country: Argentina
facility: Instituto de Cardiologia de Corrientes Juana Francisca Cabral
city: Río Cuarto
country: Argentina
facility: Instituto Medico Rio Cuarto
city: Santa Fe
country: Argentina
facility: Hospital Provincial Dr. Jose Maria Cullen
city: Auchenflower
country: Australia
facility: Wesley Research Institute
city: Fitzroy
country: Australia
facility: St Vincent's Hospital (Melbourne)
city: Anderlecht
country: Belgium
facility: Hopital Erasme
city: Santiago
country: Chile
facility: Enroll SpA
city: Praha
country: Czechia
facility: Institut klinicke a experimentalni mediciny Klinika kardiologie Ambulance plicni hypertenze
city: Praha
country: Czechia
facility: Všeobecná fakultní nemocnice v Praze ll. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hvpertenzi
city: Aarhus
country: Denmark
facility: Aarhus Universiteshospital
city: Le Kremlin-Bicêtre
country: France
facility: CHU Bicetre, Service de Pneumologie et Reanimation Respiratorie
city: Nice
country: France
facility: CHU de Nice - Hopital Pasteur
city: Poitiers
country: France
facility: CHU de Poitiers
city: Dresden
country: Germany
facility: Universitätsklinikum Dresden, Medizinische Klinik I / Pneumologisches Studiensekretariat
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie
city: München
country: Germany
facility: Krankenhaus Neuwittelsbach
city: Würzburg
country: Germany
facility: Klinikum Würzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin
city: Athens
country: Greece
facility: ATTIKON University Hospital, 2nd Critical Care Department
city: Thessaloníki
country: Greece
facility: AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - UOC Cardiologia
city: Napoli
country: Italy
facility: Azienda Ospedaliera Dei Colli - Ospedale Monaldi
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: A.O.U. Policlinico Umberto I
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos
city: Monterrey
country: Mexico
facility: Unidad de Investigacion Clinica en Medicina, S.C.
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Otwock
country: Poland
facility: Europejskie Centrum Zdrowia Otwock Sp.zo.o. Szpital im. Fryderyka Chopina Oddzial Kardiologiczny
city: Porto
country: Portugal
facility: Unidade Local de Saude de Santo Antonio, E.P.E. Hospital de Santo Antonio
city: Belgrade
country: Serbia
facility: University Clinical Centre of Serbia, Cardiology Clinic
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Singapore
country: Singapore
facility: National University Heart Centre
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial
city: Madrid
country: Spain
facility: Hospital Universitario 12 De Octubre
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital NHS Foundation Trust
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Gossamer Bio Inc.
name: Richard Aranda, MD
role: STUDY_DIRECTOR
References: