A Study of MG-K10 in Subjects With Asthma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MG-K10 Q2W Received MG-K10 300 mg subcutaneous injection every 2 weeks |
Drug: MG-K10
MG-K10 Humanized Monoclonal Antibody Injection
|
| Experimental: MG-K10 Q4W Received MG-K10 300 mg subcutaneous injection every 4 weeks |
Drug: MG-K10
MG-K10 Humanized Monoclonal Antibody Injection
Drug: Placebo
Placebo
|
| Placebo Comparator: Placebo The placebo group will receive 2 ml of placebo subcutaneously administered every 2 weeks. |
Drug: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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)
Eligibility Criteria
Criteria
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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China | 510000 |
Sponsors and Collaborators
- Shanghai Mabgeek Biotech.Co.Ltd
Investigators
- Principal Investigator: Nanshan Zhong, Medical PhD, The First Affiliated Hospital of Guangzhou Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MG-K10-AS-2