A Study of MG-K10 in Subjects With Atopic Dermatitis

February 21, 2024 updated by: Shanghai Mabgeek Biotech.Co.Ltd

Phase II Clinical Trial of Safety, Pharmacokinetics and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Atopic Dermatitis

This study evaluates the preliminary efficacy of MG-K10 in subjects with moderate to severe asthma, and provides a basis for the design and dosing regimen of phase III clinical trials.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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

This study is a multicenter, randomized, double-blind, placebo-controlled Phase II study. It is planned to enroll approximately 160 adult patients with moderate-to-severe AD uncontrolled by topical therapy, who will receive multiple subcutaneous injections. The study was divided into a screening period (1-5 weeks), a treatment period (16 weeks), and a safety follow-up (8 weeks).

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.
163

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

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
      • Bengbu, China
        • the First Affiliated Hospital of Bengbu Medical College
      • Shanghai, China
        • Huashan Hospital Affiliated to Fudan University

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

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

key Inclusion Criteria:

  1. Aged 18 - 70 years (inclusive), male or female;

  2. Patients diagnosed with AD according to American Academy of Dermatology Consensus Criteria (2014) for at least 6 months prior to screening and meet the following criteria:

    • EASI score ≥ 16 at the screening and baseline visits;
    • IGA score ≥ 3 at the screening and baseline visits;
    • AD affected body surface area (BSA) percent ≥10% at the screening and baseline visits;
    • Documented recent history (within 6 months before the screening) of inadequate response to treatment with potent topical corticosteroids for at least 4 weeks or super-potent topical corticosteroids for at least 2 weeks, or topical calcineurin inhibitors for 4 weeks, or prior systemic use of corticosteroids or immunosuppressive agents for more than 2 weeks;

Key Exclusion Criteria:

  1. Subjects currently diagnosed with other active skin disorders (e.g., psoriasis or lupus erythematosus) that may affect AD evaluation;
  2. Subjects with concomitant diseases that may require systemic hormone therapy or other interventions or require active and frequent monitoring;
  3. Subjects with unstable or not well controlled apparent cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological and psychological diseases that is considered by the investigator to be clinically significant；
  4. Patients with ocular diseases that are not suitable for enrollment by the investigator；
  5. Use of biological agents within 12 weeks prior to randomization or within 5 half-lives (whichever is longer)；
  6. Use of topical corticosteroids, topical calcineurin inhibitors, antibiotic compound cream and other topical products for AD treatment within 1 week prior to randomization;
  7. chest X-ray or CT examination within 3 months prior to screening/during the screening period suggests the presence of active tuberculosis infection；
  8. History of parasitic infection or travel to endemic areas (South America and Africa) half a year prior to screening。

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 Regimen 1
subcutaneous injection every 4 weeks (placebo injections at 2, 6, 10, 14 weeks to maintain blindness)
Drug: MG-K10
MG-K10 Humanized Monoclonal Antibody Injection
Experimental: MG-K10 Regimen 2
subcutaneous injection every 2 weeks
Drug: MG-K10
MG-K10 Humanized Monoclonal Antibody Injection
Experimental: MG-K10 Regimen 3
subcutaneous injection every 4 weeks (placebo injections at 2, 6, 10, 14 weeks to maintain blindness)
Drug: MG-K10
MG-K10 Humanized Monoclonal Antibody Injection
Placebo Comparator: Placebo
subcutaneous injection every 2 weeks
Drug: Placebo
MG-K10 Humanized Monoclonal Antibody Injection

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
Percentage change from baseline in EASI
Time Frame: 16 weeks
Percentage change from baseline in eczema area and severity index (EASI) score
16 weeks

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
Proportions of subjects achieving EASI-75
Time Frame: 16 weeks
Proportions of subjects achieving EASI-75 (≥ 75% decrease from baseline in EASI score) at W16
16 weeks
Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline
Time Frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline
2, 4, 8, 12, 16, 20 ,24 weeks
The change in NRS weekly
Time Frame: 2, 4, 8, 12, 16, 20 ,24 weeks
The change in NRS weekly mean score and percentage change from baseline at W2, W4, W8, W12, W16, W20, and W24
2, 4, 8, 12, 16, 20 ,24 weeks
Percentage change from baseline in EASI score
Time Frame: 2, 4, 8, 12, 20 ,24 weeks
Percentage change from baseline in EASI score at Weeks W2, W4, W8, W12, W20, and W24
2, 4, 8, 12, 20 ,24 weeks
Proportions of subjects achieving EASI-50
Time Frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Proportions of subjects achieving EASI-50 (≥ 50% decrease in EASI score from baseline) at W2, W4, W8, W12, W16, W20, and W24
2, 4, 8, 12, 16, 20 ,24 weeks
Proportions of subjects achieving EASI-75
Time Frame: 2, 4, 8, 12, 20 ,24 weeks
Proportions of subjects achieving EASI-75 at W2, W4, W8, W12, W20, and W24
2, 4, 8, 12, 20 ,24 weeks
Proportions of subjects achieving EASI-90
Time Frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Proportions of subjects achieving EASI-90 (≥ 90% decrease in EASI score from baseline) at W2, W4, W8, W12, W16, W20, and W24
2, 4, 8, 12, 16, 20 ,24 weeks
Absolute change from baseline in EASI scores
Time Frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Absolute change from baseline in EASI scores at W2, W4, W8, W12, W16, W20, and W24
2, 4, 8, 12, 16, 20 ,24 weeks
Absolute and percentage change from baseline in BSA score of Atopic Dermatitis
Time Frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Absolute and percentage change from baseline in BSA score of Atopic Dermatitis at W2, W4, W8, W12, W16, W20, and W24
2, 4, 8, 12, 16, 20 ,24 weeks
Proportions of subjects with a decrease in IGA score from baseline of ≥ 2
Time Frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Proportions of subjects with a decrease in IGA score from baseline of ≥ 2 at W2, W4, W8, W12, W16, W20 and W24
2, 4, 8, 12, 16, 20 ,24 weeks
Proportions of subjects with a decrease in IGA score from baseline of ≥ 3
Time Frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Proportions of subjects with a decrease in IGA score from baseline of ≥ 3 at W2, W4, W8, W12, W16, W20 and W24
2, 4, 8, 12, 16, 20 ,24 weeks
Absolute change in POEM from baseline
Time Frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Absolute change in patient oriented eczema measure (POEM) from baseline at W2, W4, W8, W12, W16, W20 and W24
2, 4, 8, 12, 16, 20 ,24 weeks
Absolute change in DLQI score from baseline
Time Frame: 2, 4, 8, 12, 16, 20 ,24 weeks
Absolute change in dermatology life quality index (DLQI) score from baseline at W2, W4, W8, W12, W16, W20 and W24
2, 4, 8, 12, 16, 20 ,24 weeks
Pharmacokinetic concentration
Time Frame: 24 weeks
To evaluate the Pharmacokinetic concentration of MG-K10
24 weeks
thymus activation regulated chemokine (TARC)
Time Frame: 24 weeks
At each evaluation time point, the changes of thymus activation regulated chemokine (TARC) were compared with baseline
24 weeks
serum immunoglobulin E (IgE)
Time Frame: 24 weeks
At each evaluation time point, the changes of serum immunoglobulin E (IgE)were compared with baseline
24 weeks
Incidence of Adverse events (AEs)
Time Frame: 24 weeks
Including vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms (ECGs)
24 weeks
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs)
Time Frame: 24 weeks
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable)
24 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: Jinhua Xu, Medical Ph.D, Huashan Hospital

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.
August 31, 2022

Primary Completion (Actual)

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.
September 22, 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.
May 26, 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).
July 13, 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.
July 18, 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.
July 20, 2022

Study Record Updates

Last Update Posted (Estimated)

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.
February 23, 2024

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.
February 21, 2024

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-AD-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

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.

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