A Study of MG-K10 in Subjects With Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-05

Study Completion Date

2024-06-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MG-K10 Q2W

Received MG-K10 300 mg subcutaneous injection every 2 weeks

Group Type EXPERIMENTAL

MG-K10

Intervention Type DRUG

MG-K10 Humanized Monoclonal Antibody Injection

MG-K10 Q4W

Received MG-K10 300 mg subcutaneous injection every 4 weeks

Group Type EXPERIMENTAL

MG-K10

Intervention Type DRUG

MG-K10 Humanized Monoclonal Antibody Injection

Placebo

Intervention Type DRUG

Placebo

The placebo group will receive 2 ml of placebo subcutaneously administered every 2 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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MG-K10

MG-K10 Humanized Monoclonal Antibody Injection

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No