Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
ConditionPulmonary Arterial Hypertension
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGossamer Bio USA, Inc.
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Seralutinib
- Gereic Dry Powder Inhaler
Treatment groups
330 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov