A Study of MG-K10 in Subjects With Atopic Dermatitis

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: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: MG-K10; Drug: Placebo

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: Interventional
• Enrollment (Estimated): 163
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Bengbu, China
    • The first affiliated hospital of bengbu medical college
  • Shanghai, China
    • Huashan Hospital Affiliated to Fudan University

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportions of subjects achieving EASI-75	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	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	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	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	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	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	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	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	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	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	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	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	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	To evaluate the Pharmacokinetic concentration of MG-K10	24 weeks
thymus activation regulated chemokine (TARC)	At each evaluation time point, the changes of thymus activation regulated chemokine (TARC) were compared with baseline	24 weeks
serum immunoglobulin E (IgE)	At each evaluation time point, the changes of serum immunoglobulin E (IgE)were compared with baseline	24 weeks
Incidence of Adverse events (AEs)	Including vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms (ECGs)	24 weeks
Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs)	Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable)	24 weeks

Collaborators and Investigators

• Sponsor: Shanghai Mabgeek Biotech.Co.Ltd
• Investigators: Principal Investigator: Jinhua Xu, Medical Ph.D, Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Actual): September 22, 2023
• Study Completion (Estimated): May 26, 2024

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Atopic dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID 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