Respiratory
Conditions
Interventions
GB0895
Placebo
Sponsors
Generate Biomedicines Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Capable of giving signed informed consent/assent according to requirements listed in the protocol. 2. Adults and adolescents =12 and =80 years of age at the time of signing the informed consent/assent. 3. Subjects must have a documented physician diagnosis of asthma for =2 years that meets the National Heart, Lung, and Blood Institute guidelines or Global Initiative for Asthma (GINA) guidelines. 4. Subjects with documented physician requirement for daily medium- to high-dose ICS for =12 months before Screening Visit 1 plus at least 1 additional controller (e.g., LABA, LAMA) =3 months before Screening Visit 1 with no change in ICS or controller(s) for at least 3 months. 5. The classification of medium and high doses of ICS should follow the GINA guidelines (GINA, 2024). 6. Subjects must have a well-documented history of at least 2 asthma exacerbations requiring systemic corticosteroid treatment despite the use of medium-to-high dose ICS in the past 12 months before Screening Visit 1. 7. Airflow obstruction as indicated a) For adults at Screening Visit 1, a pre-BD FEV1 <80% predicted recorded at Screening Visit 1. b) For adolescents at Screening Visit 1: i. A pre-BD FEV1 <90% predicted recorded at Screening Visit 1 or ii. FEV1:FVC ratio <0.8 recorded at Screening Visit 1 8. Positive BD responsiveness test: Increase of at least 12% and 200 mL in FEV1 between 15 and 60 minutes after the administration of a SABA at least once during the Screening period. 9. Asthma Control Questionnaire (ACQ-6) score =1.5 at the Screening Visit. 10. Weight =40kg at the Screening Visit 1 11. A woman of childbearing potential (WOCBP) must have a negative highly sensitive serum pregnancy test at Screening Visit 1 and a negative highly sensitive urine pregnancy test within 24 hours before the first dose of study treatment. 12. A female who is a non-WOCBP is eligible to participate. A WOCBP or a male with a WOCBP is eligible if they use a highly effective contraceptive
Exclusion criteria
Exclusion criteria: 1. Clinically significant asthma exacerbation within 12 weeks before the Screening Visit. 2. Concurrent Respiratory Disease 3. Eosinophilic Diseases 4. Cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable 5. Infection that requires systemic antibiotic, antifungal, antiparasitic or antiviral medications within 14 days before enrollment. 6. Acute, unresolved illness within 7 days before randomization 7. A current malignancy or history of cancer within 5 years before Screening 8. Helminth parasitic infection within 6 months before Screening. 9. Current smokers or subjects with smoking history. 10. Immunodeficiency disorder or positive HIV test at Screening 11. Major surgery within 8 weeks before Screening 12. Anti-IL-5 therapy in the 12 months before Screening or other monoclonal antibodies for the treatment of asthma within 4 months 13. Anti-TSLP or anti-TSLP receptor biologics 14. Systemic immunosuppressive/modulating drugs 15. Receipt of investigational biologic within 4 months or non-biologic within 30 days before Screening 16. Sensitivity to any component of the study treatment formulation. 17. History of life-threatening anaphylaxis 18. Concurrent enrollment in another study involving an IP. 19. Randomization in the current study or in previous GB-0895 studies. 20. Involvement in the planning and/or conduct of the study. 21. Abnormal finding in physical exam 22. Cirrhosis or other liver disease 23. Hepatitis B or Hepatitis C 24. Receipt of immunoglobulin within 30 days before Screening 25. Receipt of live attenuated vaccines 30 days before randomization 26. Receipt of the T2 cytokine inhibitor Suplatast tosilate within15 days before Screening 27. Subjects who have been treated with bronchial thermoplasty in the last 12 months before Screening 28. Pregnancy 29. Poor adherence to study procedures 30. Substance abuse history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of GB-0895 (300 mg subcutaneous [SC] every 26 weeks) as an adjunctive therapy, compared with placebo, in reducing clinically significant asthma exacerbations over 52 weeks in adults and adolescents with severe uncontrolled asthma. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of GB-0895 (300 mg SC every 26 weeks) as an adjunctive therapy, compared with placebo, in reducing clinically significant asthma exacerbations over 52 weeks among subjects with baseline eosinophils (EOS) <300 cells/µL. ;To assess lung function, health-related quality of life (HRQoL), and asthma control of GB 0895 compared with placebo. | — |
Countries
South Africa
Contacts
Public ContactEssack Mitha
National Principal Investigator
Outcome results
None listed