A Trial of SHR-1905 in Subjects With Severe Uncontrolled Asthma

Inclusion criteria

• Age ≥ 18.
• Documented physician-diagnosed asthma for at least 12 months.
• Participants who have received asthma controller medication with medium or high dose ICS for at least 6 months.
• Documented treatment with a total daily dose of either medium or high dose ICS (Refer to Guidelines for the prevention and management of bronchial asthma (2024 edition)) for at least 3 months.
• At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
• Pre-BD FEV1 < 80% predicted normal.
• Objective evidence of asthma as documented.
• Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
• ACQ-6 score ≥ 1.5 at screening and on day of baseline.
• ePRO adherence ≥ 70% in the 7 days prior to randomization.

Exclusion criteria

• Clinically significant pulmonary disease other than asthma.
• History of cancer.
• History of a clinically significant infection.
• Current smokers or participants with smoking history ≥ 10 pack-yrs.
• History of chronic alcohol or drug abuse within 12 months.
• Hepatitis B, C or HIV.
• Pregnant or breastfeeding.
• History of anaphylaxis following any biologic therapy.
• participant randomized in the current study or previous SHR-1905 studies.