Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT)

What this study is about

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

Who can join (things the study team will check)

✅ You may be able to join if…

• 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.

🚫 You may not be able to join if…

• 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.

Where this trial is running

• Valley Advanced Lung Diseases Institute, Fresno, California, United States
• Department of Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California, United States
• UC Davis Health Medical Center, Sacramento, California, United States
• Stanford Healthcare, Stanford, California, United States
• University of Florida Health, Gainesville, Florida, United States
• Mayo Clinic Jacksonville, Jacksonville, Florida, United States
• Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead, Atlanta, Georgia, United States
• The Emory Clinic, Atlanta, Georgia, United States
• Northside Hospital - Atlanta, Atlanta, Georgia, United States
• UI Health Hospital, Chicago, Illinois, United States
• University of Kansas Medical Center, Kansas City, Kansas, United States
• Norton Pulmonary Specialists, Louisville, Kentucky, United States

+ 108 more sites.

Who to contact

GB002 Inc. · 1-866-668-4083 · ClinicalTrials@gossamerbio.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06274801.