Dermatitis, Atopic
Conditions
Brief summary
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
DRUGMG-K10 Injection (Humanized Monoclonal Antibody)
loading dose (SC) at Week 0, followed by a single dose Q2W through Week 52
DRUGPlacebo for MG-K10
Initial loading dose (SC), then single dose Q2W through Week 52
Sponsors
Shanghai Mabgeek Biotech.Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of Atopic Dermatitis (AD) per American Academy of Dermatology (2014) criteria for ≥6 months; 2. Eczema Area and Severity Index (EASI) ≥16; 3. Investigator's Global Assessment (IGA) ≥3; 4. Body Surface Area (BSA) involvement ≥10%; 5. Peak Pruritus Numerical Rating Scale (NRS) weekly average ≥4; 6. Inadequate response to topical treatments within 6 months or medically inadvisable to use topical treatments.
Exclusion criteria
1. Inability to tolerate venipuncture, or a history of needle phobia or hematophobia; 2. Inability to receive subcutaneous injections, such as patients currently receiving anticoagulant therapy, or those with known bleeding disorders or idiopathic thrombocytopenic purpura; 3. Presence of ophthalmic diseases judged by the investigator to be unsuitable for inclusion; 4. 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; 5. History of parasitic infection within 6 months prior to screening; 6. Planned major surgery during the study period; 7. 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 8. History of alcohol or drug abuse within 6 months prior to screening; Known allergy or intolerance to any component of the investigational product. 9. Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving EASI-75 ( ≥75% reduction from baseline ) | week 16 |
| Proportion of participants achieving IGA score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline | week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Change in Peak Pruritus NRS | Baseline to week 52 |
| Proportion of participants achieving EASI-50, EASI-90 | Baseline to week 52 |
| Change and percent change from baseline in the Quality of Life Score: CDLQI and EQ-5D-Y-3L scores | Baseline to week 52 |
| Incidence in adverse events | Baseline to week 52 |
Countries
China
Contacts
CONTACTXiaofeng Cai, bachelor
Outcome results
None listed