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

NCT07276724 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: GB-0895-301 (SOLAIRIA-1)
• Study Type: interventional
• Target: 786
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Severe Asthma

Keywords

Asthma; Severe Asthma

Outcome Measures

Primary Outcomes (1)

• To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma.

  The annual exacerbation rate is based on clinically significant (CS) exacerbations reported by the investigator in the electronic case (eCRF) over 52 weeks for subjects on GB-0895 as compared to placebo.

  From Day 1 (randomization) to Week 52

Secondary Outcomes (14)

• To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma and baseline eosinophils (EOS) < 300 cells/µL.

  From Day 1 (randomization) to Week 52

• Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)

  From Day 1 (randomization) to Study Week 52

• Change from baseline in Asthma Quality of Life Questionnaire AQLQ(S)12+ score

  From Day 1 (randomization) to Week 52

• Change from baseline in Asthma Control Questionnaire (ACQ-6) score

  From Day 1 (randomization) to Week 52

• Time to first asthma exacerbation from randomization

  From Day 1 (randomization) to Week 52

Study Arms (2)

GB-0895

EXPERIMENTAL

GB-0895 Subcutaneous (SC) injection

Drug: GB-0895

Placebo

PLACEBO COMPARATOR

Placebo Subcutaneous (SC) injection

Drug: Placebo

Interventions

GB-0895 DRUG

Study Drug

GB-0895

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Generate Biomedicines: lead

Study Sites (27)

Research Site 23

Northridge, California, 91324, United States

RECRUITING

Research Site 26

Pasadena, California, 91105, United States

RECRUITING

Research Site 13

West Hills, California, 91307, United States

RECRUITING

Research Site 15

Colorado Springs, Colorado, 80923, United States

RECRUITING

Research Site 12

Doral, Florida, 33122, United States

RECRUITING

Research Site 14

Gainesville, Florida, 32607, United States

RECRUITING

Research Site 03

Hialeah, Florida, 33016, United States

RECRUITING

Research Site 25

Kendall, Florida, 33176, United States

RECRUITING

Research Site 04

Miami, Florida, 33126, United States

RECRUITING

Research Site 01

Miami Lakes, Florida, 33014, United States

RECRUITING

Research Site 08

North Miami, Florida, 33169, United States

RECRUITING

Research Site 10

Palm Springs, Florida, 33461, United States

RECRUITING

Research Site 02

Tampa, Florida, 33613, United States

RECRUITING

Research Site 18

Rincon, Georgia, 31326, United States

RECRUITING

Research Site 16

Baltimore, Maryland, 21237, United States

RECRUITING

Research Site 20

Towson, Maryland, 21204, United States

RECRUITING

Research Site 06

Flint, Michigan, 48504, United States

RECRUITING

Research Site 27

Gastonia, North Carolina, 28054, United States

RECRUITING

Research Site 24

Amarillo, Texas, 79106, United States

RECRUITING

Research Site 19

Baytown, Texas, 77521, United States

RECRUITING

Research Site 07

Dallas, Texas, 75230, United States

RECRUITING

Research Site 17

Dallas, Texas, 75254, United States

RECRUITING

Research Site 11

Houston, Texas, 77084, United States

RECRUITING

Research Site 09

Houston, Texas, 77099, United States

RECRUITING

Research Site 22

Kerrville, Texas, 78028, United States

RECRUITING

Research Site 05

Lewisville, Texas, 75057, United States

RECRUITING

Research Site 21

Riverton, Utah, 84096, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Snodgres

  Generate Biomedicines

  STUDY DIRECTOR

Central Study Contacts

Generate Recruitment

CONTACT

888-469-0033; solairiastudy@generatebiomedicines.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 11, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2025-12

Locations

US (27)