Efficacy and Safety of Inhaled AZD1402 Administered for Four Weeks in Adults with Asthma on Medium-to-High Dose Inhaled Corticosteroids - APATURA

Exclusion Criteria

• • Women who are pregnant or breastfeeding, or who are planning to become pregnant during the study.
• • Known or suspected hypersensitivity including anaphylaxis/anaphylactoid reaction following any biologic therapy, or known history of drug hypersensitivity to any component of the study intervention formulation.
• • Evidence of any active clinically important pulmonary disease other than asthma, within 5 years at screening.
• • History of pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts.
• • History or clinical suspicion of any clinically relevant or active disease or disorder.
• • History of severe COVID-19 infection requiring hospitalisation within the last 12 months or clinical history compatible with long COVID (symptoms beyond 12 weeks of acute infection).
• • Confirmed symptomatic COVID-19 infection during Screening, Run-in or prior to randomisation.
• • Current malignancy or history of malignancy.
• • Significant history of recurrent or ongoing ‘dry eye’.
• • Diagnosis of Sjögren’s syndrome.
• • High risk of infection suggesting abnormal immune function.
• • History of, or known significant infection or positivity at Screening period, including hepatitis B or C, or human immunodeficiency virus (HIV).
• • Evidence of active tuberculosis.
• • Clinically significant lower respiratory tract infection not resolved within 4 weeks prior to Screening and during Run-in.
• • Clinically significant upper respiratory tract infection at Screening and during Run-in.
• • A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained.
• • Any clinically important ECG abnormalities.
• • Any clinically significant cardiac disease.
• • Uncontrolled hypertension.
• • History of life-threatening asthma attack or asthma attack requiring ventilation.
• • Part 2 only: History of 3 or more severe asthma exacerbations.
• •Daily rescue use of SABA ≥ 8 puffs for ≥ 3 consecutive days at any time during Run-in Period, before randomisation.
• • History of anaphylaxis.
• • Any clinically significant abnormalities in haematology.
• • Alanine aminotransferase or AST level ≥ 3 times the upper limit of normal (ULN), confirmed by repeated testing during Screening Period.
• • History of, drug or alcohol abuse within the past 2 years prior to Screening.
• • Planned in-patient surgery, major dental procedure or hospitalisation during the study.
• • Prior/Concomitant Therapy: Systemic corticosteroid use, AZD1402, marketed or investigational biologicals such as monoclonal antibodies or chimeric biomolecules, investigational nonbiologic drug within 60 days prior to Screening and during Run-in, any immunosuppressive therapy, Live or attenuated vaccine within 4 weeks of Screening and during Run-in, Receipt of COVID-19 vaccine (vaccine or booster dose) within 30 days prior to randomisation, Immunoglobulin or blood products within 4 weeks of Screening and during Run-in, Any immunotherapy within 3 months of Screening and during Run-in.
• • Part 1 only: Additional asthma maintenance controller medications in addition to ICS-LABA (eg, leukotriene receptor inhibitors, theophylline, LAMA, chromones) within 3 months of Screening period and during Run-in.