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Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
Active Not RecruitingPhase 2
Sponsor: Gossamer Bio USA, Inc.
Conditions: Pulmonary Arterial Hypertension
Interventions: GB002 (seralutinib), Generic Dry Powder Inhaler
Countries: United States, Australia, Czechia, France, Germany, Spain, United Kingdom
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 overview
Sex: ALL
Age: 18 Years to 80 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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.Locations (28)
- Sacramento, California, United States
- Santa Barbara, California, United States
- Jacksonville, Florida, United States
- Weston, Florida, United States
- Kansas City, Kansas, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- New York, New York, United States
- Rochester, New York, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Hobart, Tasmania, Australia
- Fitzroy, Victoria, Australia
- Prague, Czechia
- Le Kremlin-Bicêtre, France
- Berlin, Germany
- Giessen, Germany
- Hanover, Germany
- Heidelberg, Germany
- Regensburg, Germany
- Madrid, Spain
- Santander, Spain
- Cambridge, United Kingdom
- London, United Kingdom