A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Moderate-to-severe Asthma

简要总结

主要结局

次要结局

• Change from baseline in pre-bronchodilator (BD) FEV1(From baseline to week 48)
• Change from baseline in post-BD FEV1(From baseline to week 48)
• The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD)(From baseline to week 48)
• Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score(From baseline to week 48)
• Change from baseline in ACQ-5 score(From baseline to week 48)
• Change from baseline in FeNO(From baseline to week 48)
• Time to first asthma exacerbation(From baseline to week 48)
• Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit(From baseline to week 48)
• Average number of inhalations per day of short-acting beta 2-agoinst (SABA), Low dose ICS/formoterol or ICS/SABA for symptom relief(From baseline to week 48)
• Proportion of participants with ≥0.5-point reduction in ACQ-6 and ACQ-7 score(From baseline to week 48)
• Serum lunsekimig concentrations(From baseline to week 52)
• Anti-drug antibodies (ADA) against lunsekimig(From baseline to week 52)
• Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores(From baseline to week 48)
• Proportion of participants with ≥4-point improvement in SGRQ score(From baseline to week 48)
• Change from baseline in Asthma Quality of Life Questionnaire Standardized for 12 years and older (AQLQ{S} +12) scores(From baseline to week 48)
• Proportion of participants with ≥0.5-point improvement in AQLQ(S)+12 domain and total scores(From baseline to week 48)
• Change from baseline in ACQ scores(From baseline to week 48)
• Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)(From baseline to week 52)