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

Official title

Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MG-K10 (a Humanized Monoclonal Antibody Injection) in Adolescents With Moderate-to-Severe Atopic Dermatitis

Overview

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)

Interventions

• Drug MG-K10 Injection (Humanized Monoclonal Antibody)
  loading dose (SC) at Week 0, followed by a single dose Q2W through Week 52
• Drug Placebo for MG-K10
  Initial loading dose (SC), then single dose Q2W through Week 52

Primary outcome measures

• Proportion of participants achieving EASI-75 ( ≥75% reduction from baseline ) [Time frame: week 16]
• Proportion of participants achieving IGA score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline [Time frame: week 16]

Secondary outcome measures (4)

• Change in Peak Pruritus NRS [Time frame: Baseline to week 52]
• Proportion of participants achieving EASI-50, EASI-90 [Time frame: Baseline to week 52]
• Change and percent change from baseline in the Quality of Life Score: CDLQI and EQ-5D-Y-3L scores [Time frame: Baseline to week 52]
• Incidence in adverse events [Time frame: Baseline to week 52]

Eligibility criteria

Inclusion criteria

• 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%;
• Peak Pruritus Numerical Rating Scale (NRS) weekly average ≥4;
• Inadequate response to topical treatments within 6 months or medically inadvisable to use topical treatments.

Exclusion criteria

• 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;
• History of parasitic infection within 6 months prior to screening;
• Planned major surgery during the study period;
• Prior or concomitant treatments meeting any of the following:

• Use of biologics within 10 weeks prior to randomization or within 5 half-lives (whichever is longer)
• Use of targeted inhibitors (e.g., JAK inhibitors), systemic glucocorticoids, cyclosporine, or other immunosuppressants (e.g., methotrexate, MMF, azathioprine), phosphodiesterase-4 (PDE4) inhibitors, phototherapy (UV), or systemic Chinese herbal medicine for AD within 4 weeks prior to randomization
• Use of topical treatments for AD (e.g., topical glucocorticoids, topical calcineurin inhibitors, antibiotic combination creams, or topical Chinese herbal medicine) within 2 weeks prior to randomization
• Receipt of live or attenuated vaccines within 3 months prior to randomization or plans to receive such vaccines during the study
• Participation in other clinical trials within 3 months or 5 half-lives (whichever is longer) prior to randomization, or plans to participate in other clinical trials during the study period
• Systemic anti-infective therapy (oral or intravenous antibacterial, antiviral, or antifungal) within 4 weeks prior to randomization, or current acute or subacute infection indicated by symptoms, signs, or laboratory abnormalities
• History of alcohol or drug abuse within 6 months prior to screening; Known allergy or intolerance to any component of the investigational product.
• Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• The First Hospital Of China Medical University — Shenyang

Identifiers

NCT: NCT07540442 · MG-K10-AD-006

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗