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A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)
Led by Generate Biomedicines · Updated on 2026-04-13
786
Participants Needed
11
Research Sites
153 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-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults and adolescents aged 12 to 80 years
- Physician-diagnosed asthma for at least 2 years
- Use of medium to high dose inhaled corticosteroids for at least 12 months before screening
- Use of at least one additional asthma controller for 3 or more months before screening with no recent changes
- History of at least two asthma exacerbations requiring systemic corticosteroids in the past 12 months despite treatment
- Adults 18 years or 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:FVC ratio less than 0.80
- Positive bronchodilator responsiveness test during screening
- Asthma Control Questionnaire (ACQ-6) score of 1.5 or higher at screening
- Weight of 40 kg or more at screening
You will not qualify if you...
- Clinically significant asthma exacerbation within 12 weeks before screening or during run-in requiring therapy change
- Other respiratory diseases besides asthma (e.g., infections, bronchiectasis, pulmonary fibrosis, tuberculosis, chronic pulmonary disease, lung cancer history)
- Eosinophilic diseases (e.g., eosinophilic granulomatosis with polyangiitis, eosinophilic esophagitis)
- Unstable major medical conditions affecting safety or study completion
- Ongoing significant infections requiring systemic treatment before enrollment
- Current or recent malignancy within 5 years
- Known helminth parasitic infestation within 6 months before screening
- Current smokers or history of 10 or more pack-years smoking or vaping
- Former smokers or vapers must have quit at least 6 months before screening if less than 10 pack-years
- Hepatitis B, C, or HIV infection
- Major surgery within 8 weeks before screening or planned surgery during study
- Use of anti-IL-5 or anti-TSLP biologic therapies within specified time frames before screening
- Use of systemic immunosuppressive drugs within 12 weeks before randomization
- Participation in other clinical trials involving investigational products
- Known sensitivities or life-threatening reactions to biologic therapies
- Abnormal clinical findings that pose risk or interfere with study
- Cirrhosis or significant liver disease
- Recent immunoglobulin, blood products, or live vaccines before screening
- Treatment with bronchial thermoplasty within 12 months before screening
- Inability or unwillingness to follow study procedures or poor medication adherence
- Pregnant, breastfeeding, or planning pregnancy during the study
- History or suspected alcohol or substance misuse within 2 years before screening
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Research Site 10
West Covina, California, United States, 91790
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2
Research Site 06
Miami, Florida, United States, 33126
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3
Research Site 03
Miami, Florida, United States, 33135
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4
Research 09
Orlando, Florida, United States, 32807
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5
Research Site 01
Tamarac, Florida, United States, 33321
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6
Research Site 04
Tampa, Florida, United States, 33607
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7
Research Site 05
Tampa, Florida, United States, 33617
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8
Research Site 02
Ypsilanti, Michigan, United States, 48197
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9
Research Site 11
Dayton, Ohio, United States, 45424
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10
Research Site 07
Sugar Land, Texas, United States, 77479
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11
Research Site 08
Williamsburg, Virginia, United States, 23188
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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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