Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma

Korábbi kezelés

• Receipt of any marketed biologic agent within 4 months or 5 half-lives prior to screening; Receipt of immunoglobulin or blood products within 30 days prior to screening or during the Screening Run-in period; Receipt of any live or attenuated vaccines within 15 days prior to screening
• Helminth infection within 24 weeks prior to screening
• Use of immunosuppressive medication within 3 months prior to Screening Visit or during the Screening Run-in period

Más betegség

• Participants with a known, pre-existing, clinically important lung condition other than asthma
• Tuberculosis or treatment required for tuberculosis within 12 months
• History of cancer

Egyéb

• Current or former smokers ≥10 pack years
• Participants who are pregnant, lactating or breastfeeding

• Written Informed Consent Form
• Females that are not pregnant or breastfeeding with following condition: not a woman of childbearing potential or woman of childbearing potential using a highly effective contraception method
• Physician-diagnosis of asthma and documented evidence of airway reversibility during prior 24 months or during screening
• Airflow limitation as indicated by pre-BD FEV1 value: PART A of ≥ 30% and ≤ 90%, predicted; PART B of ≥ 30% and ≤ 80%, predicted
• PART A Low, medium-, or high-dose ICS and ≥1 maintenance asthma controller medication (LABA/LTRA/LAMA/chromones/theophylline)
• PART B: medium-, or high-dose ICS and ≥1 maintenance asthma controller medication (LABA/LTRA/LAMA/chromones/theophylline)
• Part B: History of at least of 2 asthma exacerbations within 12 months before V1