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Clinical Trials/NCT06026891
NCT06026891RecruitingPhase 3

Randomized, Double-blind, Placebo-controlled Phase III Clinical Study on the Effectiveness and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Moderate to Severe Atopic Dermatitis

Shanghai Mabgeek Biotech.Co.Ltd1 site in 1 country498 target enrollmentStarted: January 13, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
498
Locations
1
Primary Endpoint
Proportions of subjects achieving EASI-75
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Detailed Description

The study was a multicenter, randomized, double-blind, placebo-controlled Phase III study. Approximately 498 adults with moderate-to-severe AD who were not controlled by local therapy were scheduled to receive multiple subcutaneous injections (administered every 4 weeks for 52 weeks). The study was divided into screening period (1-5 weeks), double-blind treatment period (16 weeks), treatment maintenance period (36 weeks), and follow-up period (8 weeks).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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;
  • •Exclusion Criteria.
  • •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;

Exclusion Criteria

  • Not provided

Arms & Interventions

MG-K10 Humanized Monoclonal Antibody Injection

Experimental

Every four weeks, subcutaneous injection ，total of 52W

Intervention: MG-K10/Placebo (Drug)

MG-K10 placebo

Placebo Comparator

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

Intervention: MG-K10/Placebo (Drug)

Outcomes

Primary Outcomes

Proportions of subjects achieving EASI-75

Time Frame: 16 weeks

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

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

Time Frame: 16weeks

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

Secondary Outcomes

  • The AD of each evaluation visit involves the change and rate of the baseline of BSA;(16 weeks)
  • Other evaluation points of view subjects with an IGA score of 0 or 1(16 weeks)
  • The percentage of subjects who reached EASI-75 at other evaluation points;(16 weeks)
  • Percentage of subjects who reach EASI-50(16 weeks)
  • Percentage of subjects who reach EASI-90(16 weeks)
  • The self-evaluation (POEM) score of patients with eczema from each evaluation point of view has changed compared with the baseline;(16 weeks)
  • Each evaluation point of view EASI(16 weeks)
  • Percentage of subjects with a weekly average of daily peak itching NRS score ≥3(16 weeks)
  • The European Five-dimensional Health Scale (EQ-5D)(16 weeks)
  • Percentage of subjects with a decrease of ≥2(16 weeks)
  • The DLQI score of each evaluation interview has changed compared with the baseline.(16 weeks)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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