study of mg-k10 humanized monoclonal antibody injection in patients with atopic dermatitis

Conditions: Atopic Dermatitis

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

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;

Keywords: atopic dermatitis