An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)

Gossamer Bio USA, Inc.

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

Description

The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.

Eligibility

Age range: 18–75 years
Sex: All
Healthy volunteers: No

Detailed 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 pre…

Interventions

Drug
Seralutinib
Capsule containing seralutinib
Device
Gereic Dry Powder Inhaler
Generic dry powder inhaler for seralutinib delivery

Locations (120)

Valley Advanced Lung Diseases Institute
Fresno, California
Department of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California
UC Davis Health Medical Center
Sacramento, California
Stanford Healthcare
Stanford, California
University of Florida Health
Gainesville, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida