Status:
ACTIVE_NOT_RECRUITING
Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
Lead Sponsor:
GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Type of Subject and Disease Characteristics
- 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.
- Treatment with standard of care PAH disease-specific background therapies (stable dose).
- Informed Consent
- Review and signature of an IRB-approved informed consent form.
Exclusion
- Medical Conditions
- Persistent and clinically significant systemic hypertension or hypotension.
- Interval history of newly developed left-sided heart disease.
- Potentially life-threatening cardiac arrhythmia with an ongoing risk.
- Uncontrolled bacterial, viral, or fungal infections which require systemic therapy.
- 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.
- History of portopulmonary hypertension or portal hypertension due to cirrhosis classified as Child-Pugh Class A or higher.
- 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.
- Current use of inhaled tobacco and/or inhaled marijuana. Ingestible or topical marijuana is allowed, per local restrictions and regulations.
- Current alcohol use disorder as defined by DSM-5, and/or history of current utilization of drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine \[PCP\]).
- 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
- Chronic renal insufficiency
- Hemoglobin (Hgb) concentration \<8.5 g/dL.
- Absolute neutrophil count (ANC) \< 1x 10\^9/L.
- Platelet count \<50 x 10\^9/L.
- Prior Therapy
- Use of inhaled prostanoids.
- Chronic use of oral anticoagulants (ie, vitamin K antagonist such as warfarin or novel oral anticoagulant \[NOAC\]/direct oral anticoagulant \[DOAC\]).
- Chronic use of any prohibited medication.
- NOTE: Additional inclusion/exclusion criteria may apply, per protocol.
Key Trial Info
Start Date :
April 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04816604
Start Date
April 5 2021
End Date
December 1 2027
Last Update
November 28 2025
Active Locations (28)
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1
University of California, Davis Medical Center
Sacramento, California, United States, 95817
2
Medical Corporation
Santa Barbara, California, United States, 93105
3
Mayo Clinic
Jacksonville, Florida, United States, 32224
4
Cleveland Clinic Florida
Weston, Florida, United States, 33331