Pulmonary Arterial Hypertension
Conditions
Keywords
seralutinib
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.
Interventions
Capsule containing GB002 (seralutinib)
Generic dry powder inhaler for GB002 (seralutinib) delivery
Sponsors
Gossamer Bio USA, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment Emergent Adverse Events | From first dose of study drug up to 80 months or availability of commercial product |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Australia, Czechia, France, Germany, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORRichard Aranda
Gossamer Bio USA, Inc.
Outcome results
None listed