A Study of MG-K10 in Subjects With Asthma

Asthma Clinical Trial

Official title:

Phase Ib/II Clinical Trial of Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Asthmatic Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05382910
• Other study ID #: MG-K10-AS-2
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 5, 2022
• Est. completion date: June 20, 2024

Study information

• Verified date: August 2023
• Source: Shanghai Mabgeek Biotech.Co.Ltd
• Contact: Xiaofeng Cai, bachelor
• Phone: 02151371305
• Email: xiaofeng.cai[@]mabgeek.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 20, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• MG-K10
MG-K10 Humanized Monoclonal Antibody Injection
• Placebo
Placebo

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mabgeek Biotech.Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	4,8,16,20,24,28,32 week
Secondary	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
Secondary	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
Secondary	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
Secondary	Time of the first severe asthma acute event	Time of the first severe asthma acute event	32 weeks
Secondary	Time of first loss of asthma control (LOAC)	Time of first loss of asthma control (LOAC)	32weeks
Secondary	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
Secondary	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)	24 and 32 week
Secondary	Daily use of first aid medicine spray	Daily use of first aid medicine spray compared with baseline	24 and 32 week
Secondary	Incidence of Adverse events (AEs)	Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing	32 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs)	Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable)	32 weeks