A Phase III Study of MG-K10 in Adolescents With Moderate-to-Severe Atopic Dermatitis

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-17
SponsorShanghai Mabgeek Biotech.Co.Ltd

About this trial

This is a randomized, double-blind, placebo-controlled, parallel group study to confirm the efficacy and safety of MG-K10 monotherapy in adolescents with moderate-to-severe atopic dermatitis (AD)

Eligibility criteria

Qualifiers

Diagnosis of Atopic Dermatitis (AD) per American Academy of Dermatology (2014) criteria for ≥6 months;

Eczema Area and Severity Index (EASI) ≥16;

Investigator's Global Assessment (IGA) ≥3;

Body Surface Area (BSA) involvement ≥10%;

Disqualifiers

Inability to tolerate venipuncture, or a history of needle phobia or hematophobia;

Inability to receive subcutaneous injections, such as patients currently receiving anticoagulant therapy, or those with known bleeding disorders or idiopathic thrombocytopenic purpura;

Presence of ophthalmic diseases judged by the investigator to be unsuitable for inclusion;

Concurrent serious diseases including, but not limited to, cardiovascular, metabolic, or neurological diseases, which, in the opinion of the investigator, render the subject unsuitable for immunosuppressive therapy;

Trial design

Treatments tested in this trial

  • MG-K10 Injection (Humanized Monoclonal Antibody)
  • Placebo for MG-K10

Treatment groups

180 Participants
are divided into 2 treatment groups