A Study of MG-K10 in Subjects With Asthma

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

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.

Study Overview

• Status: Recruiting
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: MG-K10

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 Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: xiaofeng Cai, bachelor; Phone Number: 02151371305; Email: xiaofeng.cai@mabgeek.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Jing Li, Medical Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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: Placebo; Placebo; Drug: MG-K10; MG-K10 Humanized Monoclonal Antibody Injection
Placebo Comparator: Placebo; The placebo group will receive 2 ml of placebo subcutaneously administered every 2 weeks.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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
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 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
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

Collaborators and Investigators

• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd
• Investigators: Principal Investigator: Nanshan Zhong, Medical PhD, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Estimated): December 20, 2023
• Study Completion (Estimated): June 20, 2024

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: MG-K10-AS-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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