A Study of MG-K10 in Subjects With Asthma

Shanghai Mabgeek Biotech.Co.Ltd180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

180

Conditions

Asthma

Interventions

MG-K10DRUG

MG-K10 Humanized Monoclonal Antibody Injection

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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;

Locations (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 12 week

Secondary Outcomes

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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 24 weeks and 25 to 32 weeks

Time of the first severe asthma acute event

Central Contacts

Xiaofeng Cai, bachelor

CONTACT

02151371305 xiaofeng.cai@mabgeek.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.