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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma
Led by Generate Biomedicines · Updated on 2026-05-18
786
Participants Needed
14
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating GB-0895 as an additional treatment for adolescents and adults aged 12 to 80 years with severe asthma that remains uncontrolled despite use of inhaled corticosteroids and other asthma controllers. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess the safety and effectiveness of GB-0895 in reducing asthma exacerbations over one year, with an optional open-label extension for further monitoring. Participants will be randomly assigned to receive either GB-0895 or a placebo by subcutaneous injection every six months during the 52-week treatment period. The study includes several phases: screening and baseline assessments, a run-in period, the treatment phase, and a follow-up period extending to week 90. Those who join the optional open-label extension will receive GB-0895 injections at weeks 52 and 78, continuing observation until week 142. During the study, participants will have visits every one to two months after the first month to monitor health and treatment effects. Researchers will assess asthma exacerbation rates, lung function, quality of life, asthma control, symptom diaries, respiratory questionnaires, and other health measures. Safety will be closely observed throughout the trial, which may last up to nearly three years including follow-up and extension periods.
CONDITIONS
Brief 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-documented asthma diagnosis 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 with no recent changes
- History of at least two asthma exacerbations requiring systemic corticosteroids within the past 12 months
- 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 under 0.80
- Positive bronchodilator response test during screening
- Asthma Control Questionnaire (ACQ-6) score of 1.5 or higher at screening
- Weight of at least 40 kg at screening
You will not qualify if you...
- Asthma exacerbation requiring change in maintenance therapy within 12 weeks before screening or during run-in
- Other respiratory diseases besides asthma, including infections, bronchiectasis, fibrosis, aspergillosis, tuberculosis, chronic pulmonary disease, or lung cancer history
- Eosinophilic diseases such as eosinophilic granulomatosis or esophagitis
- Unstable major medical conditions affecting safety or study completion
- Unresolved clinically significant infections requiring systemic treatment
- Current or recent cancer within 5 years
- Known helminth parasitic infestation within 6 months
- Current smokers or those with a smoking history of 10 or more pack-years; recent vaping users
- Former smokers with less than 10 pack-years must have stopped vaping or smoking for at least 6 months
- Hepatitis B, C, or HIV infection
- Major surgery within 8 weeks before screening or planned surgery during the study
- Use of anti-IL-5 therapies within 12 months or other monoclonal antibodies within 4 months prior to screening
- Prior use of anti-TSLP or anti-TSLP receptor biologics
- Recent immunosuppressive drug treatment within 12 weeks before randomization
- Recent investigational drug use prior to screening
- Known sensitivity to study treatment components
- History of life-threatening anaphylaxis to biologics
- Concurrent participation in other investigational studies
- Previous participation in GB-0895 studies
- Clinically significant abnormal lab or physical exam findings
- Cirrhosis or active liver disease
- Recent immunoglobulin or blood product receipt
- Recent live attenuated vaccine receipt
- Recent use of T2 cytokine inhibitors
- Bronchial thermoplasty within 12 months
- Poor adherence to asthma medications or inability to follow study procedures
- Pregnant, breastfeeding, or planning pregnancy during the study
- History or suspicion of alcohol or substance misuse within 2 years before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Approximately 4 weeks
Participants are observed without study drug treatment to establish baseline characteristics.
Visits as needed during run-in period
Duration - 52 weeks
Participants receive GB-0895 or placebo by subcutaneous injection every 6 months as adjunctive therapy for severe uncontrolled asthma.
2 visits for injections at Week 0 and Week 26 plus additional visits for monitoring during treatment
Duration - 38 weeks
Participants are monitored for safety and efficacy outcomes after completing the treatment phase.
Visits as scheduled between Week 52 and Week 90 for follow-up assessments
Trial Site Locations
Total: 14 locations
1
Research Site 13
Bakersfield, California, United States, 93301
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2
Research Site 12
Inglewood, California, United States, 90301
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3
Research Site 10
West Covina, California, United States, 91790
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4
Research Site 06
Miami, Florida, United States, 33126
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5
Research Site 03
Miami, Florida, United States, 33135
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6
Research 09
Orlando, Florida, United States, 32807
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7
Research Site 01
Tamarac, Florida, United States, 33321
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8
Research Site 04
Tampa, Florida, United States, 33607
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9
Research Site 05
Tampa, Florida, United States, 33617
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10
Research Site 02
Ypsilanti, Michigan, United States, 48197
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11
Research Site 11
Dayton, Ohio, United States, 45424
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12
Research Site 07
Sugar Land, Texas, United States, 77479
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13
Research Site 08
Williamsburg, Virginia, United States, 23188
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14
Research Site 14
Shinagawa-Ku, Tokyo, Japan, 140-8522
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Research Team
G
Generate Recruitment
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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