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

Running, not enrolling · Phase 2

Conditions studied: Pulmonary Arterial Hypertension

In brief

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

Key facts

Study ID

NCT04816604

Run by

Gossamer Bio USA, Inc.

People needed

74

Starts

2021-04-05

Expected to finish

2027-12-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type of Subject and Disease Characteristics
• 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.
• Treatment with standard of care PAH disease-specific background therapies (stable dose).
• Informed Consent
• Review and signature of an IRB-approved informed consent form.

You may not qualify if…

• Medical Conditions
• Persistent and clinically significant systemic hypertension or hypotension.
• Interval history of newly developed left-sided heart disease.
• Potentially life-threatening cardiac arrhythmia with an ongoing risk.
• Uncontrolled bacterial, viral, or fungal infections which require systemic therapy.
• 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.
• History of portopulmonary hypertension or portal hypertension due to cirrhosis classified as Child-Pugh Class A or higher.
• 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.
• Current use of inhaled tobacco and/or inhaled marijuana. Ingestible or topical marijuana is allowed, per local restrictions and regulations.
• Current alcohol use disorder as defined by DSM-5, and/or history of current utilization of drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine [PCP]).
• 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
• Chronic renal insufficiency
• Hemoglobin (Hgb) concentration <8.5 g/dL.
• Absolute neutrophil count (ANC) < 1x 10\^9/L.
• Platelet count <50 x 10\^9/L.
• Prior Therapy
• Use of inhaled prostanoids.
• Chronic use of oral anticoagulants (ie, vitamin K antagonist such as warfarin or novel oral anticoagulant [NOAC]/direct oral anticoagulant [DOAC]).
• Chronic use of any prohibited medication.
• NOTE: Additional inclusion/exclusion criteria may apply, per protocol.

Where it is running

• University of California, Davis Medical Center — Sacramento, California, United States
• Medical Corporation — Santa Barbara, California, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Norton Pulmonary Specialists — Louisville, Kentucky, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• NYU Langone Health — New York, New York, United States
• New York Presbyterian Hospital - Weill Cornell Medicine — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• INTEGRIS Baptist Medical Center, Inc. — Oklahoma City, Oklahoma, United States
• Houston Methodist Hospital — Houston, Texas, United States
• University of Utah Health — Salt Lake City, Utah, United States
• Royal Hobart Hospital — Hobart, Tasmania, Australia
• St. Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia
• 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

Full record on ClinicalTrials.gov

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