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
- Kaunas, LithuaniaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with pulmonary arterial hypertension who finished an earlier seralutinib study. It tests the long-term safety of inhaled seralutinib.
- Age
- 18 to 75 years
- Sex
- Men and women can join.
- Earlier treatment
- People must have finished a qualifying last visit in an earlier seralutinib PAH study while on the study drug.
Main reasons for not taking part
- Severe acute or long-lasting medical or lab problems that could raise the risk of taking part or of taking seralutinib
- Any other condition or reason that the investigator thinks rules out taking part
Read by machine on 9 November 2026.
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 Lithuania
- Lithuanian University of Health SciencesKaunas, LithuaniaNo 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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).