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Clinical Trials in the USA / NCT06274801
Recruiting Phase 3

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

NCT06274801 · tracked via the Priya Life Science USA tracker
Sponsor
Gossamer Bio USA, Inc.
Phase
Phase 3
Started
2024-09-03
Last updated
2026-07-29

Condition(s) studied

Pulmonary Arterial Hypertension

Investigational drug(s) / intervention(s)

SeralutinibGereic Dry Powder Inhaler

Seralutinib: Capsule containing seralutinib

Gereic Dry Powder Inhaler: Generic dry powder inhaler for seralutinib delivery

Study summary

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (120)

FacilityCityRegionStatus
Valley Advanced Lung Diseases Institute Fresno California Recruiting
Department of Veterans Affairs Greater Los Angeles Healthcare System Los Angeles California Recruiting
UC Davis Health Medical Center Sacramento California Recruiting
Stanford Healthcare Stanford California Recruiting
University of Florida Health Gainesville Florida Recruiting
Mayo Clinic Jacksonville Jacksonville Florida Recruiting
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead Atlanta Georgia Recruiting
The Emory Clinic Atlanta Georgia Recruiting
Northside Hospital - Atlanta Atlanta Georgia Recruiting
UI Health Hospital Chicago Illinois Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
Norton Pulmonary Specialists Louisville Kentucky Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
University of New Mexico Health Sciences Center Albuquerque New Mexico Completed
NYU Langone Health New York New York Recruiting
University of Rochester Medical Center Rochester New York Recruiting
UNC Hospitals Chapel Hill North Carolina Completed
University of Cincinnati Medical Center Cincinnati Ohio Recruiting
INTEGRIS Cardiovascular Physicians Oklahoma City Oklahoma Active Not Recruiting
The Hospital of the University of Pennsylvania Philadelphia Pennsylvania Recruiting
Temple Heart and Vascular Institute (Outpatient Clinic) Philadelphia Pennsylvania Recruiting
UPMC Presbyterian Hospital Pittsburgh Pennsylvania Recruiting
Medical University of South Carolina - Nexus Research Center Charleston South Carolina Recruiting
UT Southwestern Medical Center Dallas Texas Recruiting
CHI St. Luke's Health Baylor College of Medicine Medical Center Houston Texas Recruiting
Houston Methodist Outpatient Center Houston Texas Completed
University of Texas Health Science Center at San Antonio San Antonio Texas Recruiting
Intermountain Medical Center Murray Utah Recruiting
University of Utah Hospital Salt Lake City Utah Recruiting
Inova Fairfax Medical Campus Falls Church Virginia Recruiting
Pulmonary Associates of Richmond, Inc. Richmond Virginia Recruiting
Cardiologia Palermo Buenos Aires Argentina Recruiting
Instituto de Cardiologia de Corrientes Juana Francisca Cabral Corrientes Argentina Recruiting
Instuto de Investigacion Clinicas Quilmes Quilmes Argentina Recruiting
Instituto Medico Rio Cuarto Río Cuarto Argentina Recruiting
Hospital Provincial Dr. Jose Maria Cullen Santa Fe Argentina Recruiting
Pulmonary Hypertension Research Queensland Auchenflower Australia Recruiting
St Vincent's Hospital (Melbourne) Fitzroy Australia Recruiting

+ 80 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06274801 on ClinicalTrials.gov ↗ ← All trials in the USA