Back to resultsA Study of MG-K10 in Subjects With Asthma
Primary Purpose
Asthma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
MG-K10
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma
Eligibility 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;
Sites / Locations
- The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
MG-K10 Q2W
MG-K10 Q4W
Placebo
Arm Description
Received MG-K10 300 mg subcutaneous injection every 2 weeks
Received MG-K10 300 mg subcutaneous injection every 4 weeks
The placebo group will receive 2 ml of placebo subcutaneously administered every 2 weeks.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Percent change from baseline in pre-bronchodilator FEV1
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)
Change from peak morning and evening expiratory flow (PEF) compared with baseline (absolute and percentage)
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
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
Time of the first severe asthma acute event
Time of the first severe asthma acute event
Time of first loss of asthma control (LOAC)
Time of first loss of asthma control (LOAC)
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
Morning/evening asthma symptom score
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
Daily use of first aid medicine spray compared with baseline
Incidence of Adverse events (AEs)
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing
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
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
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
serum immunoglobulin E (IgE)
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)
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable)
Full Information
NCT ID
NCT05382910
First Posted
May 11, 2022
Last Updated
August 17, 2023
Sponsor
Shanghai Mabgeek Biotech.Co.Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05382910
Brief Title
A Study of MG-K10 in Subjects With Asthma
Official Title
Phase Ib/II Clinical Trial of Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Asthmatic Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
June 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mabgeek Biotech.Co.Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MG-K10 Q2W
Arm Type
Experimental
Arm Description
Received MG-K10 300 mg subcutaneous injection every 2 weeks
Arm Title
MG-K10 Q4W
Arm Type
Experimental
Arm Description
Received MG-K10 300 mg subcutaneous injection every 4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo group will receive 2 ml of placebo subcutaneously administered every 2 weeks.
Intervention Type
Drug
Intervention Name(s)
MG-K10
Intervention Description
MG-K10 Humanized Monoclonal Antibody Injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Absolute Change from baseline in pre-bronchodilator FEV1
Description
Absolute change from baseline in pre-bronchodilator FEV1 in each study group at 12 week of MG-K10 treatment compared with placebo
Time Frame
12 week
Secondary Outcome Measure Information:
Title
Absolute Change from baseline in pre-bronchodilator FEV1
Description
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
Time Frame
4,8,16,20,24,28,32 week
Title
Percent change from baseline in pre-bronchodilator FEV1
Description
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 Frame
4,8,16,20,24,28,32 week
Title
peak morning and evening expiratory flow (PEF)
Description
Change from peak morning and evening expiratory flow (PEF) compared with baseline (absolute and percentage)
Time Frame
4,8,12,16,20,24,28,32 week
Title
the Annualized rate of severe asthma acute event
Description
The annualized rate of severe asthma acute event within 24 weeks and 25 to 32 weeks of treatment
Time Frame
24 weeks and 25 to 32 weeks
Title
Annualized rate of the event of loss of asthma control (LOAC)
Description
the annualized rate of the event of loss of asthma control (LOAC) at 24 weeks and 25 to 32 weeks of treatment
Time Frame
24 weeks and 25 to 32 weeks
Title
Time of the first severe asthma acute event
Description
Time of the first severe asthma acute event
Time Frame
32 weeks
Title
Time of first loss of asthma control (LOAC)
Description
Time of first loss of asthma control (LOAC)
Time Frame
32weeks
Title
asthma Control Questionnaire 5 (ACQ-5 score 0-30) changes in score
Description
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
Time Frame
4, 8, 12, 16, 20, 24, 28, and 32 weeks
Title
Morning/evening asthma symptom score
Description
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)
Time Frame
24 and 32 week
Title
Daily use of first aid medicine spray
Description
Daily use of first aid medicine spray compared with baseline
Time Frame
24 and 32 week
Title
Incidence of Adverse events (AEs)
Description
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing
Time Frame
32 weeks
Title
Pharmacokinetic concentration
Description
To evaluate the Pharmacokinetic concentration of MG-K10 for each dose group. Population pharmacokinetic analysis is performed using a nonlinear mixed-effects model
Time Frame
32 weeks
Title
Fractional exhaled nitric oxide (FeNO)
Description
At each evaluation time point, the changes of Fractional exhaled nitric oxide(FeNO) were compared with baseline in each group
Time Frame
32 weeks
Title
thymus activation regulated chemokine (TARC)
Description
At each evaluation time point, the changes of thymus activation regulated chemokine (TARC) were compared with baseline in each group
Time Frame
32 weeks
Title
serum immunoglobulin E (IgE)
Description
At each evaluation time point, the changes of serum immunoglobulin E (IgE)were compared with baseline in each group
Time Frame
32 weeks
Title
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs)
Description
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable)
Time Frame
32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaofeng Cai, bachelor
Phone
02151371305
Email
xiaofeng.cai@mabgeek.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nanshan Zhong, Medical PhD
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Li, Medical Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study of MG-K10 in Subjects With Asthma
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