A Study of MG-K10 in Subjects With Atopic Dermatitis

NCT05466877 | Unknown Phase 2

• 1 other identifier: MG-K10-AD-2
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 2

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis

Outcome Measures

Primary Outcomes (1)

• Percentage change from baseline in EASI

  Percentage change from baseline in eczema area and severity index (EASI) score

  16 weeks

Secondary Outcomes (18)

• Proportions of subjects achieving EASI-75

  16 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

  2, 4, 8, 12, 16, 20 ,24 weeks

• Percentage change from baseline in EASI score

  2, 4, 8, 12, 20 ,24 weeks

• Proportions of subjects achieving EASI-50

  2, 4, 8, 12, 16, 20 ,24 weeks

Study Arms (4)

MG-K10 Regimen 1

EXPERIMENTAL

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

Drug: MG-K10

MG-K10 Regimen 2

EXPERIMENTAL

subcutaneous injection every 2 weeks

Drug: MG-K10

MG-K10 Regimen 3

EXPERIMENTAL

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

Drug: MG-K10

Placebo

PLACEBO COMPARATOR

subcutaneous injection every 2 weeks

Drug: Placebo

Interventions

MG-K10 DRUG

MG-K10 Humanized Monoclonal Antibody Injection

MG-K10 Regimen 1; MG-K10 Regimen 2; MG-K10 Regimen 3

Placebo DRUG

MG-K10 Humanized Monoclonal Antibody Injection

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Mabgeek Biotech.Co.Ltd: lead

Study Sites (2)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jinhua Xu, Medical Ph.D

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A Phase II Study of the Safety, Pharmacokinetics, Dose-Ranging and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Patients with Moderate-to-Severe Atopic Dermatitis

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 20, 2022
• Study Start: August 31, 2022
• Primary Completion: September 22, 2023
• Study Completion: May 26, 2024
• Last Updated: February 23, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)