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

Phase 2

Recruiting

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: GB002 (seralutinib); Device: Generic Dry Powder Inhaler

• Registration Number: NCT04816604
• Lead Sponsor: GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-23
• Study First Posted: 2021-03-25
• Study Start: 2021-04-05
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GB002 (seralutinib)	Generic Dry Powder Inhaler	GB002 (seralutinib) inhaled orally twice per day (BID)
GB002 (seralutinib)	GB002 (seralutinib)	GB002 (seralutinib) inhaled orally twice per day (BID)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events	From first dose of study drug up to 80 months or availability of commercial product

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Over Time on the Six-Minute Walk Test (6MWT)	Baseline, up to 80 months or availability of commercial product	Change in the distance achieved on the 6MWT (Δ6MWT)

Trial Locations

Locations (33)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Klinik und Poliklinik f. Innere Medizin II Universitätsklinikum Regensburg; 🇩🇪 Regensburg, Germany

Dept. of Veterans Affairs Greater Los Angeles Healthcare System; 🇺🇸 Los Angeles, California, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Royal Hobart Hospital; 🇦🇺 Hobart, Tasmania, Australia

NYU Langone Health; 🇺🇸 New York, New York, United States

University Hospital of Leuven; 🇧🇪 Leuven, Belgium

St. Vincent's Hospital Melbourne; 🇦🇺 Fitzroy, Victoria, Australia

University of California, Davis Medical Center; 🇺🇸 Sacramento, California, United States

Medical Corporation; 🇺🇸 Santa Barbara, California, United States

Lundquist Institute for Biomedical Innovation at Harbor UCLA; 🇺🇸 Torrance, California, United States

Stanford Health Care; 🇺🇸 Stanford, California, United States

Norton Pulmonary Specialists; 🇺🇸 Louisville, Kentucky, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

New York Presbyterian Hospital - Weill Cornell Medicine; 🇺🇸 New York, New York, United States

University of Utah Health; 🇺🇸 Salt Lake City, Utah, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

INTEGRIS Baptist Medical Center, Inc.; 🇺🇸 Oklahoma City, Oklahoma, United States

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States

St Vincent's Hospital, Heart & Lung Transplant Unit; 🇦🇺 Darlinghurst, New South Wales, Australia

Všeobecná fakultní nemocnice v Praze; 🇨🇿 Praha, Czechia

AP-HP Hôpital de Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

Klinik für Pneumologie, Klinisches Studienzentrum Medizinische Hochschule; 🇩🇪 Hannover, Germany

Universitaetsklinikum Giessen und Marburg GmbH - Medizinische Klinik IV und V; 🇩🇪 Gießen, Germany

Thoraxklinik-Heidelberg gGmbH; 🇩🇪 Heidelberg, Germany

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited; 🇬🇧 London, United Kingdom

Royal Papworth Hospital NHS Foundation Trust; 🇬🇧 Cambridge, United Kingdom

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States