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A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 108 → 132 locations Eligibility criteria expanded, about 46 words · Secondary endpoints: 14 to 21 · Study description shortened, about 43 words Show 3 more changesShow less
    • Eligibility criteria expanded, about 46 words
    • Secondary endpoints: 14 to 21
    • Study description shortened, about 43 words
  2. Trial sites expanded: 96 → 108 locations Eligibility criteria expanded, about 38 words · Secondary endpoints: details revised at 13 of 14 entries · Study description expanded, about 4 words Show 3 more changesShow less
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: details revised at 13 of 14 entries
    • Study description expanded, about 4 words
  3. Trial sites expanded: 68 → 96 locationsv14
  4. Re-verified, no change to tracked fieldsv13
  5. Trial sites expanded: 59 → 68 locationsv12
  6. Trial sites expanded: 51 → 59 locations Trial sites expanded: 34 → 51 locationsv11 Show 1 more changeShow less
    • Trial sites expanded: 34 → 51 locations
  7. Study sites: 34 to 51v10
  8. Site contacts updated at 17 of 34 sitesv9
  9. Trial sites expanded: 16 → 34 locationsv8
  10. Study sites: 14 to 16v7
  11. Trial sites expanded: 11 → 14 locationsv6
  12. Study sites: 9 to 11v5
  13. Trial sites expanded: 2 → 9 locationsv4
  14. Study sites: 1 to 2v3
  15. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jan 2026 to Jan 20, 2026v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2026 to Jan 20, 2026
  16. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The objective of this study is to assess the potential for GB-0895 to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers. Additional information is available at www.SOLAIRIA.com.
Trial Details
NCT Number NCT07359846
Lead Sponsor Generate Biomedicines
Conditions Severe Asthma
Enrollment 786 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov