A Study of MG-K10 in Subjects With Asthma
- Registration Number
- NCT05382910
- Lead Sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MG-K10 Q2W MG-K10 Received MG-K10 300 mg subcutaneous injection every 2 weeks MG-K10 Q4W Placebo Received MG-K10 300 mg subcutaneous injection every 4 weeks MG-K10 Q4W MG-K10 Received MG-K10 300 mg subcutaneous injection every 4 weeks Placebo Placebo The placebo group will receive 2 ml of placebo subcutaneously administered every 2 weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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)
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
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
Time of first loss of asthma control (LOAC) 32weeks Time of first loss of asthma control (LOAC)
Time of the first severe asthma acute event 32 weeks Time of the first severe asthma acute event
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
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
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
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
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)
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
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
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) 32 weeks Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable)
Trial Locations
- Locations (1)
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China