Asthma
Conditions
Keywords
asthma
Brief summary
This study is a phase Ib/II clinical trial conducted in Chinese adult asthmatic subjects to evaluate the preliminary efficacy and safety of MG-K10 humanized monoclonal antibody injection in the treatment of asthma.
Detailed description
The study was conducted in two phases: the Phase Ib study focused on the safety and tolerability of MG-K10 in adult asthma subjects. Phase II study focused on the preliminary efficacy in adults with moderate to severe asthma.
Interventions
DRUGMG-K10
MG-K10 Humanized Monoclonal Antibody Injection
DRUGPlacebo
Placebo
Sponsors
Shanghai Mabgeek Biotech.Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
About 180 subjects with moderate-to-severe asthma who meet the inclusion criteria will be selected for this study, according to 1:1:1 Randomly assigned to one of the MG-K10 Q2W group, the MG-K10 Q4W group, and the placebo group, with approximately 60 subjects in each group. The Q2W group will receive MG-K10 300mg subcutaneous injection every 2 weeks; Q4W group will receive MG-K10 300mg subcutaneous injection (every 4 weeks) + 2ml placebo subcutaneous injection ; the placebo group will receive 2 ml of placebo subcutaneously administered every 2 weeks. All three groups were followed up for 8 weeks after 24 weeks of treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Asthma diagnosed according to the 2021 version of the GINA guidelines for at least 1 year; * 1 second forced expiratory volume (FEV1) before randomization before bronchodilator use The measured value is ≤80% of the normal predicted value; * Must have experienced at least one severe acute asthma attack within 12 months outbreak event. * Positive bronchodilator test * Subjects and partners agree to take effective contraceptive measures from signing the Informed Consent Form (ICF) to 6 months after the end of treatment
Exclusion criteria
* Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases that may impair lung function * Subjects with malignant tumor within 5 years * Received biologics with the same therapeutic purpose within 6 months prior to screening, * Women who are breastfeeding or pregnant, or who plan to become pregnant or breastfeeding during the study period;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change from baseline in pre-bronchodilator FEV1 | 12 week | Absolute change from baseline in pre-bronchodilator FEV1 in each study group at 12 week of MG-K10 treatment compared with placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from baseline in pre-bronchodilator FEV1 | 4,8,16,20,24,28,32 week | at 4,8,16,20,24,28,32 week of MG-K10 treatment compared with placebo，Percent change from baseline in pre-bronchodilator FEV1 |
| peak morning and evening expiratory flow (PEF) | 4,8,12,16,20,24,28,32 week | Change from peak morning and evening expiratory flow (PEF) compared with baseline (absolute and percentage) |
| the Annualized rate of severe asthma acute event | 24 weeks and 25 to 32 weeks | The annualized rate of severe asthma acute event within 24 weeks and 25 to 32 weeks of treatment |
| Annualized rate of the event of loss of asthma control (LOAC) | 24 weeks and 25 to 32 weeks | the annualized rate of the event of loss of asthma control (LOAC) at 24 weeks and 25 to 32 weeks of treatment |
| Time of the first severe asthma acute event | 32 weeks | Time of the first severe asthma acute event |
| Time of first loss of asthma control (LOAC) | 32weeks | Time of first loss of asthma control (LOAC) |
| asthma Control Questionnaire 5 (ACQ-5 score 0-30) changes in score | 4, 8, 12, 16, 20, 24, 28, and 32 weeks | There are 5 questions in ACQ5, It is a questionnaire used to evaluate the degree of asthma control. Each question is scored from 0 to 6 (on a 7-point scale) according to its severity. The higher the score, the less satisfactory symptom control |
| Absolute Change from baseline in pre-bronchodilator FEV1 | 4,8,16,20,24,28,32 week | Absolute change from baseline in pre-bronchodilator FEV1 in each study group at 4,8,16,20,24,28,32 week of MG-K10 treatment compared with placebo |
| Daily use of first aid medicine spray | 24 and 32 week | Daily use of first aid medicine spray compared with baseline |
| Incidence of Adverse events (AEs) | 32 weeks | Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing |
| Pharmacokinetic concentration | 32 weeks | To evaluate the Pharmacokinetic concentration of MG-K10 for each dose group. Population pharmacokinetic analysis is performed using a nonlinear mixed-effects model |
| Fractional exhaled nitric oxide (FeNO) | 32 weeks | At each evaluation time point, the changes of Fractional exhaled nitric oxide(FeNO) were compared with baseline in each group |
| thymus activation regulated chemokine (TARC) | 32 weeks | At each evaluation time point, the changes of thymus activation regulated chemokine (TARC) were compared with baseline in each group |
| serum immunoglobulin E (IgE) | 32 weeks | At each evaluation time point, the changes of serum immunoglobulin E (IgE)were compared with baseline in each group |
| Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) | 32 weeks | Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable) |
| Morning/evening asthma symptom score | 24 and 32 week | Patients will record total symptom scores in morning（a 0-4 scale, with 0=no symptoms, 4=inability to fall asleep at night due to symptoms) and evening (a 0-4 scale, with 0=no symptoms, 4=severe symptoms, unable to work or perform daily activities) |
Countries
China
Contacts
Primary ContactXiaofeng Cai, bachelor
Outcome results
None listed