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Long-term effects of GB002 in adults with pulmonary arterial hypertension

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)

Phase 2 Interventional Gossamer Bio Inc. · NCT04816604

This study is testing the long-term effects of a medication called GB002 in adults with pulmonary arterial hypertension who have already tried it before.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorGossamer Bio Inc. Industry-sponsored
Drugs / interventionsseralutinib
Locations33 sites (Los Angeles, California and 32 other locations)
Trial IDNCT04816604 on ClinicalTrials.gov

What this trial studies

This open-label extension study evaluates the long-term effects of GB002 (seralutinib) in adult subjects who have previously participated in a GB002 study for pulmonary arterial hypertension (PAH). Participants will receive GB002 via a dry powder inhaler, and the study aims to assess the safety and efficacy of continued treatment. Eligible subjects must have completed a prior GB002 PAH study and be on stable doses of standard PAH therapies. The study focuses on monitoring the ongoing effects of the treatment over an extended period.

Who should consider this trial

Good fit: Ideal candidates are adults who have previously completed a GB002 PAH study and are compliant with study procedures.

Not a fit: Patients with significant systemic hypertension, newly developed left-sided heart disease, or uncontrolled infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term management of pulmonary arterial hypertension with GB002.

How similar studies have performed: While this study builds on previous GB002 research, the long-term effects of this specific treatment approach have not been extensively tested in other studies.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Los Angeles, California and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary Arterial Hypertensionseralutinib
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.