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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04816604
Other study ID # GB002-2102
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 5, 2021
Est. completion date December 2027

Study information

Verified date April 2024
Source Gossamer Bio Inc.
Contact GB002, Inc.
Phone 1-866-668-4083
Email ClinicalTrials@gossamerbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GB002 (seralutinib)
Capsule containing GB002 (seralutinib)
Device:
Generic Dry Powder Inhaler
Generic dry powder inhaler for GB002 (seralutinib) delivery

Locations

Country Name City State
Australia St Vincent's Hospital, Heart & Lung Transplant Unit Darlinghurst New South Wales
Australia St. Vincent's Hospital Melbourne Fitzroy Victoria
Australia Royal Hobart Hospital Hobart Tasmania
Belgium University Hospital of Leuven Leuven
Czechia VÅ¡eobecná fakultní nemocnice v Praze Praha
France AP-HP Hôpital de Bicêtre Le Kremlin-Bicêtre
Germany Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik IV und V Gießen
Germany Klinik für Pneumologie, Klinisches Studienzentrum Medizinische Hochschule Hannover
Germany Thoraxklinik-Heidelberg gGmbH Heidelberg
Germany Klinik und Poliklinik f. Innere Medizin II Universitätsklinikum Regensburg Regensburg
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Marqués de Valdecilla Santander
United Kingdom Royal Papworth Hospital NHS Foundation Trust Cambridge
United Kingdom Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited London
United States University of Michigan Ann Arbor Michigan
United States Tufts Medical Center Boston Massachusetts
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States Houston Methodist Hospital Houston Texas
United States University of Kansas Medical Center Kansas City Kansas
United States Dept. of Veterans Affairs Greater Los Angeles Healthcare System Los Angeles California
United States Norton Pulmonary Specialists Louisville Kentucky
United States New York Presbyterian Hospital - Weill Cornell Medicine New York New York
United States NYU Langone Health New York New York
United States INTEGRIS Baptist Medical Center, Inc. Oklahoma City Oklahoma
United States University of Nebraska Medical Center Omaha Nebraska
United States Oregon Health & Science University Portland Oregon
United States University of Rochester Medical Center Rochester New York
United States University of California, Davis Medical Center Sacramento California
United States Washington University School of Medicine Saint Louis Missouri
United States University of Utah Health Salt Lake City Utah
United States Medical Corporation Santa Barbara California
United States Stanford Health Care Stanford California
United States Lundquist Institute for Biomedical Innovation at Harbor UCLA Torrance California

Sponsors (1)

Lead Sponsor Collaborator
GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Czechia,  France,  Germany,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Treatment Emergent Adverse Events From first dose of study drug up to 80 months or availability of commercial product
Secondary Change from Baseline Over Time on the Six-Minute Walk Test (6MWT) Change in the distance achieved on the 6MWT (?6MWT) Baseline, up to 80 months or availability of commercial product
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