Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07359846 | A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2) | PHASE3 | RECRUITING | 786 | — | — | Jan 20, 2026 | Jan 1, 2029 | May 18, 2026 | 14 | United States, Japan |
| NCT07276724 | A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1) | PHASE3 | RECRUITING | 786 | — | — | Dec 3, 2025 | Dec 1, 2028 | May 18, 2026 | 29 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| GB-0895 | EXPERIMENTAL | GB-0895 Subcutaneous (SC) injection |
| Placebo | PLACEBO_COMPARATOR | Placebo Subcutaneous (SC) injection |
| Name | Type | Description |
|---|---|---|
| GB-0895 | DRUG | Study Drug |
| Placebo | DRUG | Placebo |
1. Adults and adolescents ≥ 12 and ≤ 80 years of age. 2. Documented physician diagnosis of asthma for ≥ 2 years. 3. Subjects must be on medium to high dose ICS for ≥ 12 months before Screening Visit 1 plus at least 1 additional asthma controller (e.g., LABA, LAMA) ≥ 3 months before Screening Visit 1...