A Study of MG-K10 in Subjects With Atopic Dermatitis

NCT ID: NCT05466877

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2024-05-26

Brief Summary

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.

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).

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MG-K10 Regimen 1

subcutaneous injection every 4 weeks (placebo injections at 2, 6, 10, 14 weeks to maintain blindness)

Group Type: EXPERIMENTAL

MG-K10

Intervention Type: DRUG

MG-K10 Humanized Monoclonal Antibody Injection

MG-K10 Regimen 2

subcutaneous injection every 2 weeks

Group Type: EXPERIMENTAL

MG-K10

Intervention Type: DRUG

MG-K10 Humanized Monoclonal Antibody Injection

MG-K10 Regimen 3

subcutaneous injection every 4 weeks (placebo injections at 2, 6, 10, 14 weeks to maintain blindness)

Group Type: EXPERIMENTAL

MG-K10

Intervention Type: DRUG

MG-K10 Humanized Monoclonal Antibody Injection

Placebo

subcutaneous injection every 2 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

MG-K10 Humanized Monoclonal Antibody Injection

Interventions

MG-K10

MG-K10 Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

Placebo

MG-K10 Humanized Monoclonal Antibody Injection

Intervention Type: DRUG

Eligibility Criteria

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;

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。

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mabgeek Biotech.Co.Ltd

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jinhua Xu, Medical Ph.D

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

The First Affiliated Hospital of Bengbu Medical College

Bengbu, , China

Huashan Hospital Affiliated to Fudan University

Shanghai, , China

Countries

China

Other Identifiers

MG-K10-AD-2

Identifier Type: -

Identifier Source: org_study_id