Study of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Atopic Dermatitis

NCT06026891 | Unknown Phase 3

• 1 other identifier: MG-K10-AD-003
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to reflect the effectiveness and safety of MG-K10 humanized monoclonal antibody injection in patients with moderate to severe atopic dermatitis.administered every 4 weeks for 52 week

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

• Proportions of subjects achieving EASI-75

  Proportions of subjects achieving EASI-75 (≥ 75% decrease from baseline in EASI

  16 weeks

• Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2

  Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline

  16weeks

Secondary Outcomes (11)

• The percentage of subjects who reached EASI-75 at other evaluation points;

  16 weeks

• Other evaluation points of view subjects with an IGA score of 0 or 1

  16 weeks

• Percentage of subjects who reach EASI-50

  16 weeks

• Percentage of subjects who reach EASI-90

  16 weeks

• Each evaluation point of view EASI

  16 weeks

Study Arms (2)

MG-K10 Humanized Monoclonal Antibody Injection

EXPERIMENTAL

Every four weeks, subcutaneous injection ，total of 52W

Drug: MG-K10/Placebo

MG-K10 placebo

PLACEBO COMPARATOR

Every four weeks, subcutaneous injection，The drug was transferred to the trial after 16 weeks

Drug: MG-K10/Placebo

Interventions

MG-K10/Placebo DRUG

MG-K10 Humanized Monoclonal Antibody Injection

MG-K10 Humanized Monoclonal Antibody Injection; MG-K10 placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-75 years (inclusive of 18 and 75 years), both sexes;
• patients with AD diagnosed in accordance with the American Academy of Dermatology Consensus Criteria (2014), with a pre-screening diagnosis of AD or history of eczema for ≥1 year, and the following:
• Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline visit;
• Investigator's Overall Assessment (IGA) ≥3 points at screening and baseline visit;
• BSA ≥10% of area of AD involvement at screening and baseline visit
• Weekly mean of peak daily itch NRS score ≥4 at randomization;
• the patient had an inadequate treatment effect on topical medication or systemic therapy within 6 months prior to the screening visit, or the use of topical medication or systemic therapy was medically inappropriate
• negative screening blood pregnancy test results in women of childbearing age;

You may not qualify if:

• subjects with a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) that may interfere with AD evaluation;
• Patients with ocular disease that, in the judgment of the Investigator, makes enrollment in the study inappropriate, e.g., past history of atopic keratoconjunctivitis with corneal involvement; if the Investigator is unable to make a determination, a diagnosis will be made by an ophthalmologist;
• those who plan to undergo major surgery during the study period, including inpatient surgery and daytime outpatient surgery;
• Subjects with the following conditions:
• Persons who have used a biologic agent within 10 weeks prior to randomization or have not exceeded 5 half-lives (whichever is longer); Targeted inhibitors (e.g., JAK inhibitors, etc.), systemic glucocorticoids, cyclosporine and other immunosuppressants (e.g., methotrexate, mycophenolate mofetil \[MMF\], and azathioprine, etc.), phosphodiesterase (PDE4) inhibitors, ultraviolet light therapy, and systemic herbal medicine for AD within 4 weeks prior to randomization;
• Has received topical glucocorticosteroids, topical calcineurin phosphatase inhibitors, antibiotic compound cream, and topical herbal therapy for AD within 1 week before randomization;
• Has received allergen-specific immunotherapy within 6 months prior to randomization;
• Live/live attenuated vaccination within 3 months prior to randomization or planned for the duration of the study;
• Participation in a clinical study of another drug in the 3 months or 5 half-lives, whichever is longer, prior to randomization or planning to participate in a clinical study of another drug during the study period;
• Subjects with prior use of an interleukin 4 receptor alpha subunit (IL-4Rα) monoclonal antibody drug who, in the judgment of the investigator, have developed drug resistance or drug-related serious AE;
• Previous participation in the MG-K10 clinical trial;
• evidence of active tuberculosis, or previous evidence of active tuberculosis without appropriate documented treatment; chest X-ray (frontal and lateral) or CT, etc. within 3 months prior to/surrounding the screening period suggesting the presence of active tuberculosis infection;
• women who are breastfeeding or pregnant, or who plan to become pregnant or breastfeed during the study;

Sponsors & Collaborators

• Shanghai Mabgeek Biotech.Co.Ltd: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

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

• Jianzhong Zhang, Medical Ph.D

  Feking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaofeng Cai, bachelor

CONTACT

02151371305; xiaofeng.cai@mabgeek.com

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: Effectiveness of MG-K10 humanized monoclonal antibody injection in patients with moderate and severe atopic dermatitis Randomized, double-blind, placebo-controlled phase III clinical study with safety

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: January 13, 2024
• Primary Completion: June 11, 2025
• Study Completion: December 12, 2025
• Last Updated: February 23, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)