Long-term study of inhaled seralutinib in adults with pulmonary arterial hypertension
Tests inhaled seralutinib over the long term in adults with pulmonary arterial hypertension.
Plain-language title generated from the registry record
Registry title: Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
Key facts
- Where
- Buenos Aires, Corrientes, Quilmes, Río Cuarto, and Santa Fe, ArgentinaSee the 5 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06274801, who can take part
Where in Argentina
- Cardiología PalermoBuenos Aires, ArgentinaTaking people
- Instituto de Cardiologia de Corrientes Juana Francisca CabralCorrientes, ArgentinaTaking people
- Instuto de Investigacion Clinicas QuilmesQuilmes, ArgentinaTaking people
- Instituto Médico Río CuartoRío Cuarto, ArgentinaTaking people
- Hospital Provincial Dr. Jose Maria CullenSanta Fe, ArgentinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gossamer Bio USA, Inc.
- Trial code
- NCT06274801EU 2023-506334-75-00
- Record updated
- 13 October 2026
- Original description
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 studyRead full original descriptionShow less
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
Inclusion: 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.
Exclusion: Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study; 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).