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NCT07359846 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
A Phase 3 study of Severe Asthma, sponsored by Generate Biomedicines.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 786
- Enrollment target
- 2
- Study locations
NCT07359846: Recruiting Phase 3 study of Severe Asthma, sponsored by Generate Biomedicines.
NCT07359846 is a Phase 3 study of Severe Asthma that is actively recruiting participants, run by Generate Biomedicines. The registered enrollment target is 786 participants, below the 3,768-participant average among 9 other Severe Asthma trials with a reported enrollment target (79% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07359846, a Phase 3 study of Severe Asthma, is actively recruiting participants, sponsored by Generate Biomedicines.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 786 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG GB-0895
Study Locations (2)
Florida
- Research Site 14 - Gainesville
- Research Site 01 - Tamarac
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 786 participants |
| Start Date | 2026-01-20 |
| Est. Completion | 2029-01 |
| Phase | Phase 3 |
What NCT07359846 shows while recruiting
NCT07359846 is an interventional study that assigns participants to a tested intervention. The registered 786 participants enrollment target is mid-sized for trials with a published cap, below the 3,768-participant average among 9 other Severe Asthma trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Severe Asthma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07359846 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT07359846 about?
NCT07359846 is a clinical study titled "A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)". 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 recei...
What is the current status of trial NCT07359846?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 786 participants. The study started on 2026-01-20. Estimated completion is 2029-01.
What conditions does trial NCT07359846 study?
This clinical trial studies the following conditions: Severe Asthma.
What interventions are being tested in trial NCT07359846?
The interventions under investigation include: Placebo (DRUG), GB-0895 (DRUG).
Who is sponsoring clinical trial NCT07359846?
This trial is sponsored by Generate Biomedicines, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07359846 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Severe Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07359846's enrollment target sits among peer trials
786 2nd of 9 higher than 7 of 9 other Severe Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Severe Asthma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)
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