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

Recruiting now · Phase 3

Conditions studied: Pulmonary Arterial Hypertension

In brief

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

Key facts

Study ID

NCT06274801

Run by

Gossamer Bio USA, Inc.

People needed

330

Starts

2024-09-03

Expected to finish

2026-12-01

Last updated by the study team

2026-07-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• CHI St. Luke's Health Baylor College of Medicine Medical Center — Houston, Texas, United States (enrolling)
• UC Davis Health Medical Center — Sacramento, California, United States (enrolling)
• Valley Advanced Lung Diseases Institute — Fresno, California, United States (enrolling)
• UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States (enrolling)
• Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead — Atlanta, Georgia, United States (enrolling)
• Stanford Healthcare — Stanford, California, United States (enrolling)
• Department of Veterans Affairs Greater Los Angeles Healthcare System — Los Angeles, California, United States (enrolling)
• University of Florida Health — Gainesville, Florida, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• Norton Pulmonary Specialists — Louisville, Kentucky, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• The Emory Clinic — Atlanta, Georgia, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• University of Rochester Medical Center — Rochester, New York, United States (enrolling)
• Northside Hospital - Atlanta — Atlanta, Georgia, United States (enrolling)
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)
• UI Health Hospital — Chicago, Illinois, United States (enrolling)
• The Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Temple Heart and Vascular Institute (Outpatient Clinic) — Philadelphia, Pennsylvania, United States (enrolling)
• UPMC Presbyterian Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
• Medical University of South Carolina - Nexus Research Center — Charleston, South Carolina, United States (enrolling)
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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