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)

  • STATUS
    Recruiting
  • End date
    Jul 22, 2025
  • participants needed
    100
  • sponsor
    GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
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Updated on 22 October 2022
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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.

Details
Condition Pulmonary Arterial Hypertension
Treatment Generic Dry Powder Inhaler, GB002 (seralutinib)
Clinical Study IdentifierNCT04816604
SponsorGB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Last Modified on22 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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