GB-0895 for Severe Uncontrolled Asthma (SOLAIRIA-1)

This study is testing an investigational drug called GB-0895 to see if it can help adults and adolescents (ages 12 to 80) with severe asthma that isn't well-controlled by their current medications. You would receive either GB-0895 or a placebo (an inactive substance) every six months for 52 weeks. The main goal is to see if GB-0895 can reduce the number of asthma attacks (exacerbations) you experience over one year. To join, you must have had asthma for at least two years and be on specific asthma controller medications. The study plans to include about 786 participants globally, but its current recruitment status is unclear.

Study design
This is a global, multi-center, randomized, double-blind, placebo-controlled Phase 3 study involving approximately 786 participants.
What's involved
You would receive study treatment every 6 months for 52 weeks, with visits every 1-2 months after the first month.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 90 weeks, or up to 142 weeks if they join the optional open-label extension.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07276724

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

Recruiting
PHASE3Ages 12–80InterventionalTreatment
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~786 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:GB-0895Placebo

At a glance

Recruiting sites
78 of 78 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma.
Measured over From Day 1 (randomization) to Week 52
Severe Asthma
78 sites across 43 states
Florida10
Texas9
California5
Maryland3
Sofia3
State of Berlin3
Riga3
Hesse2
  • Snodgres · STUDY_DIRECTOR · Generate Biomedicines

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  • To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma.From Day 1 (randomization) to Week 52

    The annual exacerbation rate is based on clinically significant (CS) exacerbations reported by the investigator in the electronic case (eCRF) over 52 weeks for subjects on GB-0895 as compared to placebo.