Active — Not RecruitingPhase 2

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

United States74 participantsStarted 2021-04-05

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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).
✓. Review and signature of an IRB-approved informed consent form.

Exclusion criteria

✕. 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.

What they're measuring

Number of Participants With Treatment Emergent Adverse Events

Timeframe: From first dose of study drug up to 80 months or availability of commercial product

Trial details

NCT IDNCT04816604

SponsorGB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

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