Actively Recruiting
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
29
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating GB-0895 as an additional treatment for adolescents and adults with severe asthma that is not controlled by inhaled corticosteroids and other common asthma medications. This global, multicenter Phase 3 trial includes a randomized, double-blind, placebo-controlled design to assess the safety and effectiveness of GB-0895 given subcutaneously every six months. The study also offers an optional open-label extension for further evaluation. Participants will be randomly assigned to receive either GB-0895 or a placebo injection at the start of the study and again after 26 weeks. The treatment period lasts 52 weeks, followed by a follow-up phase up to week 90 or an optional extension up to week 142, during which additional doses may be given. Study visits will occur every 1 to 2 months after the initial month, allowing for regular monitoring and assessments. Throughout the study, participants will undergo evaluations including lung function tests, asthma symptom questionnaires, and quality of life assessments. Researchers will closely monitor safety and measure the rate of asthma flare-ups over the year. Other outcomes include changes in lung function, asthma control, and respiratory symptoms. The total trial duration from screening to follow-up or extension can extend beyond two years depending on participant enrollment in the optional phase.
CONDITIONS
Brief 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...
- 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 plus at least one additional asthma controller for at least 3 months
- History of at least two asthma exacerbations requiring systemic corticosteroids in the past 12 months despite current treatment
- Adults 18 years or older must have pre-bronchodilator FEV1 less than 80% predicted at screening
- Adolescents 12 to less than 18 years old 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 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, pulmonary fibrosis, tuberculosis, chronic pulmonary diseases, or lung cancer history
- Eosinophilic diseases such as eosinophilic granulomatosis with polyangiitis or eosinophilic esophagitis
- Unstable major medical conditions affecting safety or study completion
- Ongoing significant infections requiring systemic treatment
- Current or recent cancer within 5 years
- Known parasitic infections within 6 months before screening
- Current smokers or history of 10 or more pack-years smoking, including vaping users
- Recent use of specific asthma biologic therapies or immunosuppressive drugs
- History of severe allergic reactions to biologic therapies
- Participation in other clinical trials with investigational products
- Pregnant, lactating, or planning pregnancy during study
- History of substance abuse within 2 years before screening
- Abnormal clinical or lab findings posing risk or study interference
- Recent surgery or planned surgery requiring general anesthesia during study
- Receipt of live vaccines within 30 days before randomization or during study
- Inability or unwillingness to follow study procedures or poor medication adherence
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)
Duration - 4 weeks
Participants undergo a run-in period before starting treatment to establish baseline conditions.
Visits during run-in period as scheduled by study staff
Duration - 52 weeks
Participants receive GB-0895 or placebo subcutaneously every 6 months while being monitored for efficacy and safety of the investigational drug.
2 subcutaneous injections at Week 0 and Week 26, with regular visits for assessments during treatment
Duration - 38 weeks
Participants are monitored for safety and outcomes after treatment ends.
Visits scheduled periodically from Week 52 to Week 90
Duration - 90 weeks
Participants have the option to continue receiving GB-0895 treatment with additional monitoring in an open-label extension phase.
Subcutaneous injections at Week 52 and Week 78 with scheduled visits until Week 142
Trial Site Locations
Total: 29 locations
1
Research Site 23
Northridge, California, United States, 91324
Actively Recruiting
2
Research Site 26
Pasadena, California, United States, 91105
Actively Recruiting
3
Research Site 29
Rancho Cucamonga, California, United States, 91730
Actively Recruiting
4
Research Site 13
West Hills, California, United States, 91307
Actively Recruiting
5
Research Site 15
Colorado Springs, Colorado, United States, 80923
Actively Recruiting
6
Research Site 12
Doral, Florida, United States, 33122
Actively Recruiting
7
Research Site 14
Gainesville, Florida, United States, 32607
Actively Recruiting
8
Research Site 03
Hialeah, Florida, United States, 33016
Actively Recruiting
9
Research Site 25
Kendall, Florida, United States, 33176
Actively Recruiting
10
Research Site 04
Miami, Florida, United States, 33126
Actively Recruiting
11
Research Site 01
Miami Lakes, Florida, United States, 33014
Actively Recruiting
12
Research Site 08
North Miami, Florida, United States, 33169
Actively Recruiting
13
Research Site 10
Palm Springs, Florida, United States, 33461
Actively Recruiting
14
Research Site 02
Tampa, Florida, United States, 33613
Actively Recruiting
15
Research Site 18
Rincon, Georgia, United States, 31326
Actively Recruiting
16
Research Site 16
Baltimore, Maryland, United States, 21237
Actively Recruiting
17
Research Site 28
Columbia, Maryland, United States, 21045
Actively Recruiting
18
Research Site 20
Towson, Maryland, United States, 21204
Actively Recruiting
19
Research Site 06
Flint, Michigan, United States, 48504
Actively Recruiting
20
Research Site 27
Gastonia, North Carolina, United States, 28054
Actively Recruiting
21
Research Site 24
Amarillo, Texas, United States, 79106
Actively Recruiting
22
Research Site 19
Baytown, Texas, United States, 77521
Actively Recruiting
23
Research Site 07
Dallas, Texas, United States, 75230
Actively Recruiting
24
Research Site 17
Dallas, Texas, United States, 75254
Actively Recruiting
25
Research Site 11
Houston, Texas, United States, 77084
Actively Recruiting
26
Research Site 09
Houston, Texas, United States, 77099
Actively Recruiting
27
Research Site 22
Kerrville, Texas, United States, 78028
Actively Recruiting
28
Research Site 05
Lewisville, Texas, United States, 75057
Actively Recruiting
29
Research Site 21
Riverton, Utah, United States, 84096
Actively Recruiting
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here