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A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)
Led by Generate Biomedicines · Updated on 2026-04-27
786
Participants Needed
27
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 12 and 80 years
- Diagnosed with asthma by a doctor for at least 2 years
- Using medium to high dose inhaled corticosteroids for at least 12 months plus at least one additional asthma controller for at least 3 months without changes
- History of at least two asthma exacerbations requiring systemic corticosteroids in the past 12 months
- Adults (18 years and older) must have pre-bronchodilator FEV1 less than 80% predicted
- Adolescents (12 to under 18 years) must have pre-bronchodilator FEV1 less than 90% predicted or FEV1 to Forced Vital Capacity ratio less than 0.80
- Positive bronchodilator responsiveness test during screening
- Asthma Control Questionnaire (ACQ-6) score of 1.5 or higher at screening
- Weigh at least 40 kg at screening
You will not qualify if you...
- Experienced a significant asthma exacerbation within 12 weeks before screening or during run-in requiring a change in asthma maintenance therapy
- Have other respiratory diseases besides asthma, including infections or chronic pulmonary diseases
- Have eosinophilic diseases such as eosinophilic granulomatosis with polyangiitis or eosinophilic esophagitis
- Have unstable major physical or mental health conditions
- Have unresolved infections requiring systemic treatment
- Have current or recent history of cancer within 5 years
- Have known parasitic infestations within 6 months before screening
- Current smokers or with a smoking history of 10 or more pack-years, or use vaping products
- Former smokers with less than 10 pack-years must have quit for at least 6 months
- Have hepatitis B, C, or HIV
- Had major surgery within 8 weeks before screening or planned surgeries during the study
- Used certain biologic therapies or immunosuppressive drugs within specified timeframes before screening
- Known allergy to study treatments
- History of life-threatening allergic reactions to biologics
- Enrolled in another clinical study with investigational products
- Previously participated in GB-0895 studies
- Abnormal clinical findings that may risk safety or study completion
- Have cirrhosis or active liver disease
- Received immunoglobulin or blood products within 30 days before screening
- Received live vaccines within 30 days before or during the study
- Received T2 cytokine inhibitors within 15 days before screening
- Treated with bronchial thermoplasty in the last 12 months
- Unable or unwilling to follow study procedures or poor adherence to asthma medications
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- History or suspected history of alcohol or substance abuse within 2 years before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Research Site 23
Northridge, California, United States, 91324
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2
Research Site 26
Pasadena, California, United States, 91105
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3
Research Site 13
West Hills, California, United States, 91307
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4
Research Site 15
Colorado Springs, Colorado, United States, 80923
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5
Research Site 12
Doral, Florida, United States, 33122
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6
Research Site 14
Gainesville, Florida, United States, 32607
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7
Research Site 03
Hialeah, Florida, United States, 33016
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8
Research Site 25
Kendall, Florida, United States, 33176
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9
Research Site 04
Miami, Florida, United States, 33126
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10
Research Site 01
Miami Lakes, Florida, United States, 33014
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11
Research Site 08
North Miami, Florida, United States, 33169
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12
Research Site 10
Palm Springs, Florida, United States, 33461
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13
Research Site 02
Tampa, Florida, United States, 33613
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14
Research Site 18
Rincon, Georgia, United States, 31326
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15
Research Site 16
Baltimore, Maryland, United States, 21237
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16
Research Site 20
Towson, Maryland, United States, 21204
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17
Research Site 06
Flint, Michigan, United States, 48504
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18
Research Site 27
Gastonia, North Carolina, United States, 28054
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19
Research Site 24
Amarillo, Texas, United States, 79106
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20
Research Site 19
Baytown, Texas, United States, 77521
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21
Research Site 07
Dallas, Texas, United States, 75230
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22
Research Site 17
Dallas, Texas, United States, 75254
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23
Research Site 11
Houston, Texas, United States, 77084
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24
Research Site 09
Houston, Texas, United States, 77099
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25
Research Site 22
Kerrville, Texas, United States, 78028
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26
Research Site 05
Lewisville, Texas, United States, 75057
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27
Research Site 21
Riverton, Utah, United States, 84096
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Research Team
G
Generate Recruitment
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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