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Clinical Trials in the UK / NCT07359846
Recruiting Phase 3

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)

NCT07359846 · tracked via the Priya Life Science UK tracker
Sponsor
Generate Biomedicines
Phase
Phase 3
Started
2026-01-20
Last updated
2026-09-08

Condition(s) studied

Severe Asthma

Investigational drug(s) / intervention(s)

GB-0895Placebo

GB-0895: Study Drug

Placebo: Placebo

Study summary

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (96)

FacilityCityRegionStatus
Research Site 13 Bakersfield California Recruiting
Research Site 12 Inglewood California Recruiting
Research Site 65 Lancaster California Recruiting
Research Site 10 West Covina California Recruiting
Research Site 06 Miami Florida Recruiting
Research Site 03 Miami Florida Recruiting
Research 09 Orlando Florida Recruiting
Research Site 01 Tamarac Florida Recruiting
Research Site 04 Tampa Florida Recruiting
Research Site 05 Tampa Florida Recruiting
Research Site 20 Fall River Massachusetts Recruiting
Research Site 02 Ypsilanti Michigan Recruiting
Research Site 69 New York New York Recruiting
Research Site 69 New York New York Recruiting
Research Site 11 Dayton Ohio Recruiting
Research Site 21 Oklahoma City Oklahoma Recruiting
Research Site 16 Rock Hill South Carolina Recruiting
Research Site 17 San Antonio Texas Recruiting
Research Site 07 Sugar Land Texas Recruiting
Research Site 08 Williamsburg Virginia Recruiting
Research Site 31 Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Research Site 87 Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Research Site 79 Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Research Site 92 Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Research Site 33 Ciudad Autónoma de Buenos Aires Buenos Aires Recruiting
Research Site 67 Buenos Aires Buenos Aires F.D. Recruiting
Research Site 81 Concepción del Uruguay Entre Ríos Province Recruiting
Research Site 80 Mendoza Mendoza Province Recruiting
Research Site 100 San Miguel de Tucumán Tucumán Province Recruiting
Research Site 72 Coffs Harbour New South Wales Recruiting
Research site 39 Southport Queensland Recruiting
Research Site 22 Mechelen Vlaams Brabant Recruiting
Research Site 73 Mechelen Vlaams Brabant Recruiting
Research Site 45 Erpent Belgium Recruiting
Research Site 95 Tartu Tartu Recruiting
Research Site 101 Tartu Tartu Recruiting
Research Site 53 Brest Finistère Recruiting
Research Site 99 Trieste Friuli Venezia Giulia Recruiting
Research Site 68 Seto-shi Aiti Recruiting
Research Site 23 Matsuyama Ehime Recruiting

+ 56 more sites — see the full list on the official registry below.

More Generate Biomedicines trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07359846 on ClinicalTrials.gov ↗ ← All trials in the UK