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Clinical Trials in the USA / NCT07276724
Recruiting Phase 3

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)

NCT07276724 · tracked via the Priya Life Science USA tracker
Sponsor
Generate Biomedicines
Phase
Phase 3
Started
2025-12-03
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 23 Northridge California Recruiting
Research Site 26 Pasadena California Recruiting
Research Site 29 Rancho Cucamonga California Recruiting
Research Site 34 Valencia California Recruiting
Research Site 13 West Hills California Recruiting
Research Site 15 Colorado Springs Colorado Recruiting
Research Site 32 Brooksville Florida Recruiting
Research Site 12 Doral Florida Recruiting
Research Site 14 Gainesville Florida Recruiting
Research Site 03 Hialeah Florida Recruiting
Research Site 25 Kendall Florida Recruiting
Research Site 04 Miami Florida Recruiting
Research Site 01 Miami Lakes Florida Recruiting
Research Site 08 North Miami Florida Recruiting
Research Site 10 Palm Springs Florida Recruiting
Research Site 02 Tampa Florida Recruiting
Research Site 18 Rincon Georgia Recruiting
Research Site 31 Glenview Illinois Recruiting
Research Site 16 Baltimore Maryland Recruiting
Research Site 28 Columbia Maryland Recruiting
Research Site 20 Towson Maryland Recruiting
Research Site 06 Flint Michigan Recruiting
Research Site 30 Olive Branch Mississippi Recruiting
Research Site 37 The Bronx New York Recruiting
Research Site 27 Gastonia North Carolina Recruiting
Research Site 83 Winston-Salem North Carolina Recruiting
Research Site 24 Amarillo Texas Recruiting
Research Site 19 Baytown Texas Recruiting
Research Site 07 Dallas Texas Recruiting
Research Site 17 Dallas Texas Recruiting
Research Site 11 Houston Texas Recruiting
Research Site 09 Houston Texas Recruiting
Research Site 22 Kerrville Texas Recruiting
Research Site 05 Lewisville Texas Recruiting
Research Site 33 McKinney Texas Recruiting
Research Site 21 Riverton Utah Recruiting
Research Site 56 Haskovo Haskovo Recruiting
Research Site 54 Pleven Pleven Recruiting
Research Site 55 Plovdiv Plovdiv Recruiting
Research Site 73 Rousse Ruse Recruiting

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

More Generate Biomedicines trials in the USA

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 NCT07276724 on ClinicalTrials.gov ↗ ← All trials in the USA