Clinical Trial

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The objective of this study is to assess the potential for GB-0895 treatment to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers. The study details include: Study treatment: randomized to receive either GB-0895 or placebo administered every 6 months over 52 weeks. Visit frequency: every 1-2 months after the first month.
Protocol Amendment History 5 changes
notable Trial sites expanded: 53 -> 67 locations 2026-08-04
notable Trial sites expanded: 35 -> 53 locations 2026-07-21
notable Trial sites expanded: 29 -> 35 locations 2026-06-12
notable Trial sites expanded: 21 -> 25 locations 2026-04-14
notable Trial sites expanded: 13 -> 21 locations 2026-04-03
Trial Details
NCT Number NCT07276724
Lead Sponsor Generate Biomedicines
Conditions Severe Asthma
Enrollment 786 participants
Start Date 2025-12-03
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-03