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Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)
RecruitingPhase 3
An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)
Who can join
Ages 18 to 75 · All sexes
Full 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.
About the study
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
What is being tested
- Seralutinib (drug)
- Gereic Dry Powder Inhaler (device)
Sponsor: Gossamer Bio USA, Inc. · Participants: 330 · Started: Sep 3, 2024
Contact the study team
- GB002 Inc. · Phone: 1-866-668-4083
Official record on ClinicalTrials.gov — NCT06274801
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.