Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG-K10 Q2W | Experimental | Received MG-K10 300 mg subcutaneous injection every 2 weeks |
|
| MG-K10 Q4W | Experimental | Received MG-K10 300 mg subcutaneous injection every 4 weeks |
|
| Placebo | Placebo Comparator | The placebo group will receive 2 ml of placebo subcutaneously administered every 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MG-K10 | Drug | MG-K10 Humanized Monoclonal Antibody Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change from baseline in pre-bronchodilator FEV1 | Absolute change from baseline in pre-bronchodilator FEV1 in each study group at 12 week of MG-K10 treatment compared with placebo | 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change from baseline in pre-bronchodilator FEV1 | 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 | 4,8,16,20,24,28,32 week |
| Percent change from baseline in pre-bronchodilator FEV1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaofeng Cai, bachelor | Contact | 02151371305 | xiaofeng.cai@mabgeek.com |
| Name | Affiliation | Role |
|---|---|---|
| Nanshan Zhong, Medical PhD | The First Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42212541 | Derived | Xian M, Shi X, Li R, Zhao L, Zhuan B, Chen B, Shi H, Wang Z, Wu F, Guo J, Chen Y, Dang W, Guo J, Qin D, Zhang C, Li J, Zhong N. Phase Ib/II Study of Preliminary Efficacy, Safety and Pharmacodynamics of MG-K10, a Humanised Monoclonal Antibody Targeting IL-4Ralpha, in Adult Chinese Patients With Asthma. Clin Exp Allergy. 2026 May 29. doi: 10.1111/cea.70345. Online ahead of print. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo |
|
at 4,8,16,20,24,28,32 week of MG-K10 treatment compared with placeboļ¼Percent change from baseline in pre-bronchodilator FEV1 |
| 4,8,16,20,24,28,32 week |
| peak morning and evening expiratory flow (PEF) | Change from peak morning and evening expiratory flow (PEF) compared with baseline (absolute and percentage) | 4,8,12,16,20,24,28,32 week |
| the Annualized rate of severe asthma acute event | The annualized rate of severe asthma acute event within 24 weeks and 25 to 32 weeks of treatment | 24 weeks and 25 to 32 weeks |
| Annualized rate of the event of loss of asthma control (LOAC) | the annualized rate of the event of loss of asthma control (LOAC) at 24 weeks and 25 to 32 weeks of treatment | 24 weeks and 25 to 32 weeks |
| Time of the first severe asthma acute event | Time of the first severe asthma acute event | 32 weeks |
| Time of first loss of asthma control (LOAC) | Time of first loss of asthma control (LOAC) | 32weeks |
| asthma Control Questionnaire 5 (ACQ-5 score 0-30) changes in score | 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 | 4, 8, 12, 16, 20, 24, 28, and 32 weeks |
| Morning/evening asthma symptom score | Patients will record total symptom scores in morningļ¼a 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) | 24 and 32 week |
| Daily use of first aid medicine spray | Daily use of first aid medicine spray compared with baseline | 24 and 32 week |
| Incidence of Adverse events (AEs) | Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing | 32 weeks |
| Pharmacokinetic concentration | To evaluate the Pharmacokinetic concentration of MG-K10 for each dose group. Population pharmacokinetic analysis is performed using a nonlinear mixed-effects model | 32 weeks |
| Fractional exhaled nitric oxide (FeNO) | At each evaluation time point, the changes of Fractional exhaled nitric oxide(FeNO) were compared with baseline in each group | 32 weeks |
| thymus activation regulated chemokine (TARC) | At each evaluation time point, the changes of thymus activation regulated chemokine (TARC) were compared with baseline in each group | 32 weeks |
| serum immunoglobulin E (IgE) | At each evaluation time point, the changes of serum immunoglobulin E (IgE)were compared with baseline in each group | 32 weeks |
| Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) | Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable) | 32 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |