Clinical trial NCT06026891: Study of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Lead sponsor: Shanghai Mabgeek Biotech.Co.Ltd
Sponsor class: OTHER_GOV
First posted: 2023-09-07
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. age 18-75 years (inclusive of 18 and 75 years), both sexes;
2. 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;
3. 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
4. negative screening blood pregnancy test results in women of childbearing age;

Exclusion Criteria.

1. subjects with a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) that may interfere with AD evaluation;
2. 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;
3. those who plan to undergo major surgery during the study period, including inpatient surgery and daytime outpatient surgery;
4. 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;
5. 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;
6. women who are breastfeeding or pregnant, or who plan to become pregnant or breastfeed during the study;

Primary outcomes:
measure: Proportions of subjects achieving EASI-75
timeFrame: 16 weeks
measure: Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2
timeFrame: 16weeks
Secondary outcomes:
measure: The percentage of subjects who reached EASI-75 at other evaluation points;
timeFrame: 16 weeks
measure: Other evaluation points of view subjects with an IGA score of 0 or 1
timeFrame: 16 weeks
measure: Percentage of subjects who reach EASI-50
timeFrame: 16 weeks
measure: Percentage of subjects who reach EASI-90
timeFrame: 16 weeks
measure: Each evaluation point of view EASI
timeFrame: 16 weeks
measure: Percentage of subjects with a decrease of ≥2
timeFrame: 16 weeks
measure: Percentage of subjects with a weekly average of daily peak itching NRS score ≥3
timeFrame: 16 weeks
measure: The AD of each evaluation visit involves the change and rate of the baseline of BSA;
timeFrame: 16 weeks
measure: The DLQI score of each evaluation interview has changed compared with the baseline.
timeFrame: 16 weeks
measure: The self-evaluation (POEM) score of patients with eczema from each evaluation point of view has changed compared with the baseline;
timeFrame: 16 weeks
measure: The European Five-dimensional Health Scale (EQ-5D)
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Feking University People's Hospital
name: Jianzhong Zhang, Medical Ph.D
role: PRINCIPAL_INVESTIGATOR
References: