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

StatusTerminated
PhasePhase 2
Started

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Record History

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  1. Re-verified, no change to tracked fields
  2. Trial terminated Sponsor's reason: Enrollment has declined and remaining participants have been on study more than three years. Continued study visits/data collection are no longer considered necessary. This is not expected to affect study interpretation or the overall benefit-risk. Show 4 more changesShow less
    • Primary completion date changed from estimate of Dec 2027 to Sep 9, 2026
    • Eligibility criteria expanded, about 20 words
    • Site details revised at 1 of 28 sites
    • Publications: details revised at 1 of 1 entry
  3. Sponsor changed: GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. to Gossamer Bio USA, Inc.v25
  4. 3 versions Re-verified since Jan 20, 2026, no change to tracked fieldsv22-v24
  5. Study sites: 30 to 28v21
Show 19 earlier versionsHide 19 earlier versions
  1. Study sites: 31 to 30v20
  2. Study sites: 37 to 31v19
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 74
    • Study sites: 33 to 37
    v18
  4. Primary and study completion dates: Jul 2025 to Dec 2027
    • Study sites: 29 to 33
    • Secondary endpoints: details revised at 1 of 1 entry
    v17
  5. Study sites: 28 to 29v16
  6. Study sites: 26 to 28v15
  7. Study sites: 22 to 26v14
  8. Study sites: 21 to 22v13
  9. Study sites: 16 to 21v12
  10. Study sites: 14 to 16v11
  11. Primary and study completion dates: Dec 2023 to Jul 2025
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 1 entry
    v10
  12. Study sites: 13 to 14v9
  13. Study sites: 12 to 13v8
  14. Study sites: 9 to 12v7
  15. Study sites: 6 to 9v6
  16. Study sites: 5 to 6v5
  17. Study sites: 4 to 5v4
  18. Study sites: 1 to 4v3
  19. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Interventions: GB002 (Drug), Generic Dry Powder Inhaler (Device) to GB002 (seralutinib) (Drug), Generic Dry Powder Inhaler (Device)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.
Trial Details
NCT Number NCT04816604
Lead Sponsor Gossamer Bio USA, Inc.
Conditions
(from sponsor)		 Pulmonary Arterial Hypertension
Related terms Pulmonary Arterial Hypertension
Enrollment 74 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov