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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Severe Asthma

In brief

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.

Key facts

Study ID

NCT07276724

Run by

Generate Biomedicines

People needed

786

Starts

2025-12-03

Expected to finish

2028-12-01

Last updated by the study team

2026-08-03

Who can join

Age: 12 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.
• 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.
• Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis, eosinophilic esophagitis).
• 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.
• Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding enrollment.
• A current malignancy or previous history of cancer within 5 years before screening.
• Clinically significant infection that is not resolved before study enrollment.
• Subjects with a known, pre-existing helminth parasitic infestation within 6 months before Screening Visit 1.
• Current smokers or subjects with a smoking history ≥10 pack-years, and subjects using vaping products, including electronic cigarettes.
• 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.
• Hepatitis B, C, or HIV.
• 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.
• 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.
• Prior use (at any time) of any anti-TSLP or anti-TSLP receptor biologics, approved (e.g., tezepelumab) or investigational.
• Treatment with systemic immunosuppressive/immunomodulating drugs (e.g., methotrexate, cyclosporine) within 12 weeks prior to randomization.
• 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.
• Known history of sensitivity to any component of the study treatment formulation.
• History of life-threatening anaphylaxis following any biologic therapy.
• Concurrent enrollment in another clinical study involving investigational product (IP).
• Subject has been randomized in the current study or previous GB-0895 studies.
• 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.
• Cirrhosis (with or without hepatic dysfunction) or other active or clinically significant liver disease.
• Receipt of immunoglobulin or blood products within 30 days before Screening Visit 1.
• Receipt of live attenuated vaccines within 30 days before randomization and during the study, including the follow-up period.
• Receipt of the T2 cytokine inhibitor suplatast tosilate within 15 days before Screening Visit 1.

Where it is running

• Research Site 26 — Pasadena, California, United States (enrolling)
• Research Site 29 — Rancho Cucamonga, California, United States (enrolling)
• Research Site 34 — Valencia, California, United States (enrolling)
• Research Site 13 — West Hills, California, United States (enrolling)
• Research Site 15 — Colorado Springs, Colorado, United States (enrolling)
• Research Site 32 — Brooksville, Florida, United States (enrolling)
• Research Site 12 — Doral, Florida, United States (enrolling)
• Research Site 14 — Gainesville, Florida, United States (enrolling)
• Research Site 03 — Hialeah, Florida, United States (enrolling)
• Research Site 25 — Kendall, Florida, United States (enrolling)
• Research Site 04 — Miami, Florida, United States (enrolling)
• Research Site 01 — Miami Lakes, Florida, United States (enrolling)
• Research Site 08 — North Miami, Florida, United States (enrolling)
• Research Site 10 — Palm Springs, Florida, United States (enrolling)
• Research Site 02 — Tampa, Florida, United States (enrolling)
• Research Site 18 — Rincon, Georgia, United States (enrolling)
• Research Site 31 — Glenview, Illinois, United States (enrolling)
• Research Site 16 — Baltimore, Maryland, United States (enrolling)
• Research Site 28 — Columbia, Maryland, United States (enrolling)
• Research Site 20 — Towson, Maryland, United States (enrolling)
• Research Site 06 — Flint, Michigan, United States (enrolling)
• Research Site 30 — Olive Branch, Mississippi, United States (enrolling)
• Research Site 37 — The Bronx, New York, United States (enrolling)
• Research Site 27 — Gastonia, North Carolina, United States (enrolling)
• Research Site 23 — Northridge, California, United States (enrolling)

Full record on ClinicalTrials.gov

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