Phase II Trial of RC1416 Injection in Asthma

RC1416 is a bispecific homodimer nanobody .It is being developed by Nanjing RegeneCore Biotech Co., Ltd. as a potential therapy for asthma. A total 195 severe uncontrolled asthma subjects will be enrolled in three groups to access the efficacy and safety of RC1416.

Inclusion criteria

• Male or female aged 18 and 75 years.
• Diagnosed with asthma for at least 1 year, and the current disease status meets the diagnostic criteria of the 2024 GINA guidelines.
• Have received medium-to-high dose ICS therapy for at least 3 consecutive months prior to screening, and maintained a stable treatment regimen and dose for ≥1 month prior to baseline.
• Pre-bronchodilator forced expiratory volume in 1 second (FEV1) measurement ≤80% of the predicted normal value at both the screening and baseline visits.
• Asthma Control Questionnaire-6 (ACQ-6) score ≥1.5 at both the screening and baseline visits.
• Must have experienced ≥1 severe asthma exacerbation event within the 12 months prior to screening.
• Positive bronchodilator reversibility test.

Exclusion criteria

• Individuals with a known history of allergy to the investigational product or its excipients.
• Clinically diagnosed with chronic obstructive pulmonary disease (COPD) or other lung diseases that may impair lung function .
• Experienced a severe asthma exacerbation event from within 1 month prior to screening until before dosing.
• Used systemic corticosteroids within 1 month prior to screening.
• Had a pulmonary or other site infection requiring intravenous antibiotics, antifungals, or antivirals from within 1 month prior to screening until before dosing.
• Used traditional Chinese medicine with anti-asthmatic effects within 1 month prior to screening.
• Underwent major surgery within 8 weeks prior to screening or plans to undergo major surgery during the study period.
• With a history of malignancy within the past 5 years .
• Active or incompletely treated tuberculosis
• Used biologic/systemic immunosuppressant/immunomodulators within 12 weeks or 5 half-lives prior to screening.
• Diagnosed active parasitic infection; suspected parasitic infection or high risk of infection.
• Abnormal 12-lead electrocardiogram (ECG) at screening. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial