Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
Key facts
- Where
- Belo Horizonte, Blumenau, Porto Alegre, and São Paulo, BrazilSee the 6 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 Brazil
- Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre TeresaBelo Horizonte, BrazilTaking people
- Complexo de Prevencao, Diagnostico, Terapia e Reabilitacao Respiratoria - Hospital Dia di PulmaoBlumenau, BrazilTaking people
- Irmandade Da Santa Casa de Misericordia de Porto AlegrePorto Alegre, BrazilTaking people
- Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRSPorto Alegre, BrazilTaking people
- Instituto do Coracao do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao PauloSão Paulo, BrazilTaking people
- Nucleo de Gestao de Pesquisa/Hospital Sao Paulo - SPDM/UNIFESPSão Paulo, BrazilNo longer taking part
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).