A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)
Recruiting · NCT07276724 · Interventional (participants receive a specific treatment) · Lead sponsor: Generate Biomedicines
View the official record on ClinicalTrials.gov →Interventions studied
GB-0895Placebo
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.
Who can take part
Age range
12 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Eligibility criteria (as published)
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 with no change in ICS or controller(s) for at least three months.
4. Subjects must have a well-documented history of at least two asthma exacerbations requiring systemic corticosteroid treatment despite the use of medium-to-high dose ICS in the past 12 months before Screening Visit 1.
5. Adults ≥ 18 years of age at Screening Visit 1, a pre-BD FEV1 \<80% predicted at Screening Visit 1.
6. Adolescents 12 to \< 18 years of age at Screening Visit 1: A pre-BD FEV1 \< 90% predicted OR, FEV1:Forced Vital Capacity (FVC) ratio \< 0.80.
7. Positive BD responsiveness test: Increase of at least 12% and 200 mL in FEV1 between 15 and 60 minutes after the administration of a short-acting β2-agonist (SABA) at least once during the screening period.
8. ACQ-6 score ≥ 1.5 at the Screening Visit.
9. Weight ≥40 kg at the Screening Visit 1
Exclusion Criteria:
1. Subjects who experience a clinically significant asthma exacerbation within 12 weeks before the Screening Visit or during the run-in period and require a change in asthma maintenance therapy.
2. Other concurrent respiratory disease other than asthma, including (but not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, tuberculosis, diagnosis of chronic pulmonary disease (including but not limited to emphysema and/or chronic bronchitis), or a history of lung cancer.
3. Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis, eosinophilic esophagitis).
4. Any cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could affect subject safety, influence study findings or interpretation, or impede completion of the study.
5. Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding enrollment.
6. A current malignancy or previous history of cancer within 5 years before screening.
7. Clinically significant infection that is not resolved before study enrollment.
8. Subjects with a known, pre-existing helminth parasitic infestation within 6 months before Screening Visit 1.
9. Current smokers or subjects with a smoking history ≥10 pack-years, and subjects using vaping products, including electronic cigarettes.
10. Former smokers with a smoking history of \<10 pack-years and users of vaping/e-cigarette products must have stopped for at least 6 months before Screening Visit 1 to be eligible.
11. Hepatitis B, C, or HIV.
12. Major surgery within 8 weeks before Screening Visit 1 or planned surgical procedures requiring general anesthesia or inpatient status for \>1 day during the study.
13. Use of any anti-IL-5 therapy (e.g., mepolizumab, reslizumab, benralizumab, depemokimab) within 12 months before Screening Visit 1 or other monoclonal antibodies used for asthma within 4 months or 5 half-lives.
14. Prior use (at any time) of any anti-TSLP or anti-TSLP receptor biologics, approved (e.g., tezepelumab) or investigational.
15. Treatment with systemic immunosuppressive/immunomodulating drugs (e.g., methotrexate, cyclosporine) within 12 weeks prior to randomization.
16. Receipt of an investigational biologic within 4 months or 5 half-lives, OR receipt of an investigational non-biologic within 30 days or 5 half-lives before Screening Visit 1.
17. Known history of sensitivity to any component of the study treatment formulation.
18. History of life-threatening anaphylaxis following any biologic therapy.
19. Concurrent enrollment in another clinical study involving investigational product (IP).
20. Subject has been randomized in the current study or previous GB-0895 studies.
21. Any clinically meaningful abnormal finding in physical examination, vital signs, ECG, hematology, serum chemistry, or urinalysis that, in the opinion of the Investigator, may put the subject at risk, influence study results, or impede study completion.
22. Cirrhosis (with or without hepatic dysfunction) or other active or clinically significant liver disease.
23. Receipt of immunoglobulin or blood products within 30 days before Screening Visit 1.
24. Receipt of live attenuated vaccines within 30 days before randomization and during the study, including the follow-up period.
25. Receipt of the T2 cytokine inhibitor suplatast tosilate within 15 days before Screening Visit 1.
26. Subjects treated with bronchial thermoplasty in the last 12 months before Screening Visit 1.
27. Unwillingness or inability to follow study procedures, including poor adherence to asthma controller medications, in the opinion of the Investigator.
28. Women who are pregnant, lactating, or planning to become pregnant during the study.
29. History (or suspected history) of alcohol misuse or substance abuse within 2 years before Screening Visit 1.
Where it is running
60 locations listed across 12 US states.
- Research Site 23 - Northridge, California, United States
- Research Site 26 - Pasadena, California, United States
- Research Site 29 - Rancho Cucamonga, California, United States
- Research Site 34 - Valencia, California, United States
- Research Site 13 - West Hills, California, United States
- Research Site 15 - Colorado Springs, Colorado, United States
- Research Site 32 - Brooksville, Florida, United States
- Research Site 12 - Doral, Florida, United States
- Research Site 14 - Gainesville, Florida, United States
- Research Site 03 - Hialeah, Florida, United States
- Research Site 25 - Kendall, Florida, United States
- Research Site 04 - Miami, Florida, United States
- Research Site 01 - Miami Lakes, Florida, United States
- Research Site 08 - North Miami, Florida, United States
- Research Site 10 - Palm Springs, Florida, United States
- Research Site 02 - Tampa, Florida, United States
- Research Site 18 - Rincon, Georgia, United States
- Research Site 31 - Glenview, Illinois, United States
- Research Site 16 - Baltimore, Maryland, United States
- Research Site 28 - Columbia, Maryland, United States
- Research Site 20 - Towson, Maryland, United States
- Research Site 06 - Flint, Michigan, United States
- Research Site 30 - Olive Branch, Mississippi, United States
- Research Site 37 - The Bronx, New York, United States
- Research Site 27 - Gastonia, North Carolina, United States
- Research Site 83 - Winston-Salem, North Carolina, United States
- Research Site 24 - Amarillo, Texas, United States
- Research Site 19 - Baytown, Texas, United States
- Research Site 07 - Dallas, Texas, United States
- Research Site 17 - Dallas, Texas, United States
- Research Site 11 - Houston, Texas, United States
- Research Site 09 - Houston, Texas, United States
- Research Site 22 - Kerrville, Texas, United States
- Research Site 05 - Lewisville, Texas, United States
- Research Site 33 - McKinney, Texas, United States
- Research Site 21 - Riverton, Utah, United States
- Research Site 40 - Berlin, Germany
- Research Site 86 - Jablonec nad Nisou, Czechia
- Research Site 92 - Leipzig, Germany
- Research Site 43 - Lübeck, Germany
- Research Site 94 - Teplice, Czechia
- Research Site 90 - Athens, Attica, Greece
- Research Site 42 - Deggingen, Baden-Wurttemberg, Germany
- Research Site 53 - Szigetvár, Baranya Varmegye, Hungary
- Research Site 80 - München, Bavaria, Germany
- Research Site 41 - Oradea, Bihor County, Romania
- Research Site 50 - Brasov, Brașov County, Romania
- Research Site 35 - Bucharest, Bucharest, Romania
- Research Site 84 - Bucharest, Bucharest, Romania
- Research Site 45 - Budapest, Budapest, Hungary
- Research Site 87 - Cluj-Napoca, Cluj, Romania
- Research Site 66 - Cluj-Napoca, Cluj, Romania
- Research Site 64 - Cluj-Napoca, Cluj, Romania
- Research Site 85 - Varnsdorf, Czechia, Czechia
- Research Site 51 - Craiova, Dolj, Romania
- Research Site 82 - Thessaloniki, Exochi, Greece
- Research Site 48 - Figueira da Foz Municipality, Figueira da Foz, Portugal
- Research Site 61 - Welkom, Free State, South Africa
- Research Site 89 - Johannesburg, Gauteng, South Africa
- Research Site 59 - Johannesburg, Gauteng, South Africa
Showing 60 of 96 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →