Moderate to Severe Asthma
Conditions
Brief summary
This study is a phase II study of RC1416 in subjects with severe uncontrolled asthma. The purpose of the study is to evaluate efficacy and safety of RC1416 in subjects with severe uncontrolled asthma.
Detailed description
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.
Interventions
DRUGRC1416
There are two doses in this part. Each subjects will receive the drug by subcutaneous injection.
DRUGRC1416 Placebo
Each subjects will receive the placebo by subcutaneous injection
Sponsors
Nanjing RegeneCore Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 week 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-bronchodilator (Pre-BD) forced expiratory volume in 1 Second (FEV1) | During 32 weeks | Mean change from baseline in Pre-BD forced expiratory volume in 1 Second (FEV1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe asthma exacerbation | During 32 weeks | Severe asthma exacerbation events, Time to the first asthma exacerbation |
| Pre-BD FEV1 | During 32 weeks | — |
| Morning and evening peak expiratory flow (PEF) | During 32 weeks | Mean change from baseline of absolute value and percentage |
| forced vital capacity (FVC) | During 32 weeks | Mean change from baseline of absolute value and percentage |
| Forced mid-expiratory flow (FEF25-75%) before bronchodilator (BD) | During 32 weeks | Mean change from baseline of absolute value and percentage |
| Asthma loss of control (LOAC) | During 32 weeks | Asthma loss of control (LOAC) events, Time to the first Asthma loss of control |
| Acute exacerbation of severe asthma - induced hospitalization or Emergency Department visit | During 32 weeks | Acute exacerbation of severe asthma - induced hospitalization or Emergency Department visit events |
| Asthma Control Questionnaire-6 (ACQ-6) score | During 32 weeks | Mean change Mean change from baseline. The proportion of trial participants with a reduction of ≥0.5 points from baseline |
| Asthma Quality of Life Questionnaire (AQLQ-S) score | During 32 weeks | Mean change from baseline |
| weekly Asthma Symptom Diary (ASD) score | During 32 weeks | Mean change in mean weekly from baseline |
| Rescue medication | During 32 weeks | Mean change in mean weekly from baseline |
| Adverse Events | During 32 weeks | — |
| Pharmacokinetics | During 32 weeks | trough concentration |
| Pharmacodynamics | During 32 weeks | mean changes of Pharmacodynamic Parameter from baseline |
| Anti-Drug antibody | During 32 weeks | number and percentage of subjects tested ADA positive |
Countries
China
Contacts
CONTACTGuo Qian
Outcome results
None listed