A Phase 2 Randomized, Double-blind Placebo-Controlled Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety and Efficacy of WIN378 in Adult Participants with Moderate or Severe Asthma

Asthma

1. Treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), vital signs, laboratory assessments, and electrocardiogram (ECG) during the trial (Week 0 [Day 1] to Week 60)., 2. WIN378 PK and anti-drug antibodies (ADA) during the trial (Week 0 [Day 1] to Week 60).

1. Change from baseline in FeNO at week 24, 2. Change from baseline in FEV1 at Week 24 and Week 48, 3. Change from baseline in FeNO at Week 24 and Week 48, 4. Change from baseline in BEC at Week 24 and Week 48, 5. An exposure-response analysis will be done to support selection of the optimal dose(s) for future testing. The analysis will describe the exposure-response relationship between concentration of WIN378 and change in FeNO, FEV1, and eosinophil count over 48 weeks., 6. Change from baseline in lung function as measured by pre-bronchodilator (BD) and post-BD FEV1 and forced vital capacity (FVC) at Week 24 and Week 48, 7a. Change from baseline in asthma symptoms (daytime and nighttime symptom frequency and severity, activity avoidance and limitation, asthma-related stress and fatigue as well as rescue asthma medication use) as measured by the Asthma Symptom Diary, and other measures of asthma control as measured by the Asthma Control Questionnaire (ACQ-6) at Week 48 in the overall population., 7b. Annualized asthma exacerbation rate (AAER), annualized rate of severe asthma exacerbations, time to first asthma exacerbation/severe asthma exacerbation, and proportion of participants with 1 or more asthma exacerbations/severe asthma exacerbations over 48 weeks, 7c. Change from baseline in Asthma Quality of Life Questionnaire (Standardised) (AQLQ[S]+12) and European Quality of Life - 5 Dimensions 5 Level Version (EQ-5D-5L) at Week 48

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