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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified November 2025 by Generate Biomedicines
Sponsor
Generate Biomedicines
Information Provided by (Responsible Party)
Generate Biomedicines
Clinicaltrials.gov Identifier
NCT07359846
Other Study ID Numbers:
GB-0895-302 (SOLAIRIA-2)
First Submitted
January 20, 2026
First Posted
January 21, 2026
Last Update Posted
April 12, 2026
Last Verified
November 2025

ClinicalTrials.gov processed this data on April 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

This is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study to evaluate the efficacy and safety of GB-0895 adjunctive therapy in adults and adolescents with severe uncontrolled asthma with an optional open-label extension (OLE). The trial is designed to administer GB-0895 an investigational drug or placebo, subcutaneously every 6 months.

The study is divided into several phases as described below:

* Screening/Baseline (Weeks -6 to -4)

* Run-in (Weeks -4 to 0, ±1)

* Treatment (Weeks 0 to 52)

* Follow-up (Weeks 52 to 90) or optional open-label extension (OLE) (Weeks 52 to 142, OLE includes GB-0895 treatment on Week 52 and Week 78)

Approximately 786 eligible study participants will be screened and randomized globally to receive either GB-0895 or placebo at week 0 and week 26. The safety of the participants enrolled in this trial will be carefully monitored.

Condition or DiseaseIntervention/Treatment
Severe Asthma
Drug: GB-0895Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment786 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma
Study Start DateJanuary 19, 2026
Actual Primary Completion Date2yrs 8mos from now
Actual Study Completion Date2yrs 8mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
GB-0895
GB-0895 Subcutaneous (SC) injection
Drug: GB-0895
Study Drug
Placebo
Placebo Subcutaneous (SC) injection
Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures
  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.
Secondary Outcome Measures
  1. To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma and baseline eosinophils (EOS) < 300 cells/µL.
    The annual exacerbation rate is based on CS exacerbations reported by the investigator in the eCRF over 52 weeks for subjects with baseline EOS \&lt; 300 cells/ &micro;L on GB-0895 as compared to placebo.
  2. Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
    The change from baseline in pre-BD FEV1 for subjects on GB-0895 as compared to placebo at week 52. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
  3. Change from baseline in Asthma Quality of Life Questionnaire AQLQ(S)12+ score
    The change from baseline on AQLQ(S)12+ score for subjects on GB-0895 as compared to placebo at week 52. The AQLQ(S)12+ is a 32-question assessment with questions related to symptoms, activity limitations, emotional function, and environmental stimuli. Questions are scored on a 7-point scale, which ranges from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean to all questions.
  4. Change from baseline in Asthma Control Questionnaire (ACQ-6) score
    The change from baseline on ACQ-6 score for subjects on GB-0895 as compared to placebo at week 52. The ACQ-6 is a 6-question questionnaire that assesses asthma symptoms (e.g., activity limitation, shortness of breath, wheezing etc.). Questions are scored on a 6-point scale, where 0 corresponds to totally controlled asthma and 6 corresponds to severely uncontrolled asthma.
  5. Time to first asthma exacerbation from randomization
    After subjects complete the screening period and are randomized to either GB-0895 or placebo, the time it takes until the first clinically significant asthma exacerbation occurs. Clinically significant asthma exacerbations are defined as requiring systemic corticosteroids (oral, IV, or intramuscular) and/or hospitalization or emergency department visits requiring systemic corticosteroids.
  6. Change from baseline in weekly mean daily Asthma Daytime Symptom Diary (ADSD)
    The change from baseline on weekly mean daily ADSD score for subjects on GB-0895 as compared to placebo at week 52. The ADSD is an 8-question diary that assesses asthma symptoms that the subjects will fill out at night before bed. The ADSD daily score is calculated by averaging the 8 daily score and a mean of 7-day ADSD score is calculated by averaging of the 7 daily score. The daily score is not calculated if any item response is missing.
  7. Change from baseline in weekly mean daily Asthma Nighttime Symptom (ANSD)
    The change from baseline on daily ANSD score for subjects on GB-0895 as compared to placebo at week 52. ANSD is an eight-question diary that assesses asthma symptoms that the subjects will fill out in the morning upon waking. The ANSD score is calculated by averaging the 8 daily score and a mean of 7-day ANSD score is calculated by averaging of the seven daily score.
  8. Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score
    The change from baseline on SGRQ score for subjects on GB-0895 as compared to placebo at week 52. The SGRQ is a 50-item questionnaire designed to measure health status. Questions are scored on a range of 0 to 100, with a lower score indicating a better quality of life
  9. Change from baseline in 22-Item Sino-Nasal Outcomes Test (SNOT-22) score
    The change from baseline on SNOT-22 score for subjects on GB-0895 as compared to placebo at week 52.The SNOT-22 is a 22-question questionnaire that assesses the impact on health-related quality of life and questions are scored from 0 to 110, with 0 indicating no disease and 110 as the worst disease.
  10. Change from baseline in the 5-Level EuroQol 5 dimensions questionnaire (EQ-5D-5L) score
    The change from baseline on EQ-5D-5L score for subjects on GB-0895 as compared to placebo at week 52. The EQ-5D-5L questionnaire includes a visual analogue scale (VAS) that allows subjects to rate current health status on a 0-100 scale, with 0 being the worst imaginable health state.
  11. PGI-S response at Week 52
    The Patient Global Impression of Asthma Severity (PGI-S) at Week 52 defined as an improvement by 1 or more points on the 0-5 scale. The PGI-S questionnaire asks the subjects to rate the overall severity of their asthma symptoms of the past 7 days with response options of: 1= no asthma symptoms, 2= mild, 3= moderate, 4= severe, and 5= worst possible asthma symptoms.
  12. ACQ-6 response at Week 52
    The Asthma Control Questionnaire-6 (ACQ-6) at Week 52 defined as an improvement in score of 0.5 or more. The ACQ-6 questionnaire is a 6-question subject-reported questionnaire that assesses the most common asthma symptoms and responses are calculated from the mean of the scores out of a value of 6, where 0 corresponds to totally controlled asthma and 6 corresponds to severely uncontrolled asthma.
  13. AQLQ(S)12+ response at Week 52
    The Asthma Quality of Life Questionnaire for 12-Year-Old and Older at week 52 defined as an improvement in score of 0.5 or more. The AQLQ(S)12+ is a 32-question subject-reported assessment. The questions are scored on a 7-point scale, which ranges from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean of all questions.
  14. SGRQ response at Week 52
    The St. George&#039;s Respiratory Questionnaire at week 52 defined as achieving &ge; 4-point reduction from baseline. The SGRQ is a 50-item questionnaire designed to measure health status and questions are scored on a range of 0 to 100, with a lower score indicating a better quality of life.

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
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.

Contacts and Locations

Sponsors and CollaboratorsGenerate Biomedicines
Locations
Research Site 10 | West Covina California, United States, 91790Research Site 06 | Miami Florida, United States, 33126Research Site 03 | Miami Florida, United States, 33135Research 09 | Orlando Florida, United States, 32807Research Site 01 | Tamarac Florida, United States, 33321Research Site 04 | Tampa Florida, United States, 33607Research Site 05 | Tampa Florida, United States, 33617Research Site 02 | Ypsilanti Michigan, United States, 48197Research Site 11 | Dayton Ohio, United States, 45424Research Site 07 | Sugar Land Texas, United States, 77479Research Site 08 | Williamsburg Virginia, United States, 23188
Investigators
Study Director: Snodgres, Generate Biomedicines