🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT04816604
Active, not recruiting Phase 2

Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

NCT04816604 · tracked via the Priya Life Science USA tracker
Sponsor
Gossamer Bio USA, Inc.
Phase
Phase 2
Started
2021-04-05
Last updated
2026-07-27

Condition(s) studied

Pulmonary Arterial Hypertension

Investigational drug(s) / intervention(s)

GB002 (seralutinib)Generic Dry Powder Inhaler

GB002 (seralutinib): Capsule containing GB002 (seralutinib)

Generic Dry Powder Inhaler: Generic dry powder inhaler for GB002 (seralutinib) delivery

Study summary

This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: Type of Subject and Disease Characteristics 1. Subjects must have completed a prior GB002 PAH study and, in the opinion of the Investigator and Sponsor, have been compliant with study procedures and have completed treatment with IP through parent study end-of-treatment (EOT) visit. 2. Treatment with standard of care PAH disease-specific background therapies (stable dose). Informed Consent 3. Review and signature of an IRB-approved informed consent form. Exclusion Criteria: Medical Conditions 1. Persistent and clinically significant systemic hypertension or hypotension. 2. Interval history of newly developed left-sided heart disease. 3. Potentially life-threatening cardiac arrhythmia with an ongoing risk. 4. Uncontrolled bacterial, viral, or fungal infections which require systemic therapy. 5. Other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or GB002 administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study. 6. History of portopulmonary hypertension or portal hypertension due to cirrhosis classified as Child-Pugh Class A or higher. 7. Subjects with a history of severe milk protein allergy. In addition, subjects with known intolerance or hypersensitivity to lactose who, in the opinion of the investigator, may experience severe symptoms following the ingestion of lactose. 8. Current use of inhaled tobacco and/or inhaled marijuana. Ingestible or topical marijuana is allowed, per local restrictions and regulations. 9. Current alcohol use disorder as defined by DSM-5, and/or history of current utilization of drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine \[PCP\]). 10. Have any other condition or reason that, in the opinion of the Investigator and/or the Sponsor's Medical Monitor (or designee), would prohibit the subject from participating in the study. Diagnostic Assessments 11. Chronic renal insufficiency 12. Hemoglobin (Hgb) concentration \<8.5 g/dL. 13. Absolute neutrophil count (ANC) \< 1x 10\^9/L. 14. Platelet count \<50 x 10\^9/L. Prior Therapy 15. Use of inhaled prostanoids. 16. Chronic use of oral anticoagulants (ie, vitamin K antagonist such as warfarin or novel oral anticoagulant \[NOAC\]/direct oral anticoagulant \[DOAC\]). 17. Chronic use of any prohibited medication. NOTE: Additional inclusion/exclusion criteria may apply, per protocol.

Primary outcome measure(s)

Trial sites (28)

FacilityCityRegionStatus
University of California, Davis Medical Center Sacramento California
Medical Corporation Santa Barbara California
Mayo Clinic Jacksonville Florida
Cleveland Clinic Florida Weston Florida
University of Kansas Medical Center Kansas City Kansas
Norton Pulmonary Specialists Louisville Kentucky
Tufts Medical Center Boston Massachusetts
University of Nebraska Medical Center Omaha Nebraska
NYU Langone Health New York New York
New York Presbyterian Hospital - Weill Cornell Medicine New York New York
University of Rochester Medical Center Rochester New York
The Ohio State University Wexner Medical Center Columbus Ohio
INTEGRIS Baptist Medical Center, Inc. Oklahoma City Oklahoma
Houston Methodist Hospital Houston Texas
University of Utah Health Salt Lake City Utah
Royal Hobart Hospital Hobart Tasmania
St. Vincent's Hospital Melbourne Fitzroy Victoria
Všeobecná fakultní nemocnice v Praze Prague Czechia
AP-HP Hôpital de Bicêtre Le Kremlin-Bicêtre France
DRK Kliniken Berlin Berlin Germany
Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik IV und V Giessen Germany
Klinik für Pneumologie, Klinisches Studienzentrum Medizinische Hochschule Hanover Germany
Thoraxklinik-Heidelberg gGmbH Heidelberg Germany
Klinik und Poliklinik f. Innere Medizin II Universitätsklinikum Regensburg Regensburg Germany
Hospital Universitario 12 de Octubre Madrid Spain
Hospital Universitario Marqués de Valdecilla Santander Spain
Royal Papworth Hospital NHS Foundation Trust Cambridge United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited London United Kingdom
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 NCT04816604 on ClinicalTrials.gov ↗ ← All trials in the USA