A Study of MG-K10 in Subjects With Asthma

August 17, 2023 updated by: Shanghai Mabgeek Biotech.Co.Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Absolute Change from baseline in pre-bronchodilator FEV1
Time Frame: 12 week
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absolute Change from baseline in pre-bronchodilator FEV1
Time Frame: 4,8,16,20,24,28,32 week
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
Time Frame: 4,8,16,20,24,28,32 week
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)
Time Frame: 4,8,12,16,20,24,28,32 week
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
Time Frame: 24 weeks and 25 to 32 weeks
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)
Time Frame: 24 weeks and 25 to 32 weeks
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 Frame: 32 weeks
Time of the first severe asthma acute event
32 weeks
Time of first loss of asthma control (LOAC)
Time Frame: 32weeks
Time of first loss of asthma control (LOAC)
32weeks
asthma Control Questionnaire 5 (ACQ-5 score 0-30) changes in score
Time Frame: 4, 8, 12, 16, 20, 24, 28, and 32 weeks
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
Time Frame: 24 and 32 week
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
Time Frame: 24 and 32 week
Daily use of first aid medicine spray compared with baseline
24 and 32 week
Incidence of Adverse events (AEs)
Time Frame: 32 weeks
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing
32 weeks
Pharmacokinetic concentration
Time Frame: 32 weeks
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)
Time Frame: 32 weeks
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)
Time Frame: 32 weeks
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)
Time Frame: 32 weeks
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)
Time Frame: 32 weeks
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable)
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Mabgeek Biotech.Co.Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nanshan Zhong, Medical PhD, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings