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

Pulmonary Arterial Hypertension Clinical Trial

Official title:

An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04816604
• Other study ID #: GB002-2102
• Status: Recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

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	Všeobecná 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