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FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.","From Day 1 (randomization) to Study Week 52",{"measure":22,"description":23,"timeFrame":12},"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.",{"measure":25,"description":26,"timeFrame":12},"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.",{"measure":28,"description":29,"timeFrame":12},"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\u002For hospitalization or emergency department visits requiring systemic corticosteroids.",{"measure":31,"description":32,"timeFrame":12},"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.\n\nThe 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.",{"measure":34,"description":35,"timeFrame":12},"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.\n\nANSD 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.",{"measure":37,"description":38,"timeFrame":12},"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",{"measure":40,"description":41,"timeFrame":12},"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.",{"measure":43,"description":44,"timeFrame":12},"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.",{"measure":46,"description":47,"timeFrame":12},"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.",{"measure":49,"description":50,"timeFrame":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.\n\nThe 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.",{"measure":52,"description":53,"timeFrame":12},"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.",{"measure":55,"description":56,"timeFrame":12},"SGRQ response at Week 52","The St. George's Respiratory Questionnaire at week 52 defined as achieving ≥ 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.",null,{"allocation":59,"interventionModel":60,"interventionModelDescription":57,"primaryPurpose":61,"observationalModel":57,"timePerspective":57,"maskingInfo":62},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":63,"maskingDescription":57,"whoMasked":64},"TRIPLE",[65,66,67],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","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.\n\nThe study is divided into several phases as described below:\n\n* Screening\u002FBaseline (Weeks -6 to -4)\n* Run-in (Weeks -4 to 0, ±1)\n* Treatment (Weeks 0 to 52)\n* 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)\n\nApproximately 786 eligible study participants will be screened and randomized globally to receive either GB-0895 or placebo at week 0 and week 26. 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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.\n8. ACQ-6 score ≥ 1.5 at the Screening Visit.\n9. Weight ≥40 kg at the Screening Visit 1\n\nExclusion Criteria:\n\n1. 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.\n2. 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\u002For chronic bronchitis), or a history of lung cancer.\n3. Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis, eosinophilic esophagitis).\n4. 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.\n5. Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding enrollment.\n6. A current malignancy or previous history of cancer within 5 years before screening.\n7. Clinically significant infection that is not resolved before study enrollment.\n8. Subjects with a known, pre-existing helminth parasitic infestation within 6 months before Screening Visit 1.\n9. Current smokers or subjects with a smoking history ≥10 pack-years, and subjects using vaping products, including electronic cigarettes.\n10. Former smokers with a smoking history of \\\u003C10 pack-years and users of vaping\u002Fe-cigarette products must have stopped for at least 6 months before Screening Visit 1 to be eligible.\n11. Hepatitis B, C, or HIV.\n12. 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.\n13. 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.\n14. Prior use (at any time) of any anti-TSLP or anti-TSLP receptor biologics, approved (e.g., tezepelumab) or investigational.\n15. Treatment with systemic immunosuppressive\u002Fimmunomodulating drugs (e.g., methotrexate, cyclosporine) within 12 weeks prior to randomization.\n16. 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.\n17. Known history of sensitivity to any component of the study treatment formulation.\n18. History of life-threatening anaphylaxis following any biologic therapy.\n19. Concurrent enrollment in another clinical study involving investigational product (IP).\n20. Subject has been randomized in the current study or previous GB-0895 studies.\n21. 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.\n22. Cirrhosis (with or without hepatic dysfunction) or other active or clinically significant liver disease.\n23. Receipt of immunoglobulin or blood products within 30 days before Screening Visit 1.\n24. Receipt of live attenuated vaccines within 30 days before randomization and during the study, including the follow-up period.\n25. Receipt of the T2 cytokine inhibitor suplatast tosilate within 15 days before Screening Visit 1.\n26. Subjects treated with bronchial thermoplasty in the last 12 months before Screening Visit 1.\n27. Unwillingness or inability to follow study procedures, including poor adherence to asthma controller medications, in the opinion of the Investigator.\n28. Women who are pregnant, lactating, or planning to become pregnant during the study.\n29. 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