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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG-K10 | Experimental | loading dose (SC) at Week 0, followed by a single dose Q2W through Week 52 |
|
| Placebo | Placebo Comparator | Initial loading dose (SC), then single dose Q2W through Week 52 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MG-K10 Injection (Humanized Monoclonal Antibody) | Drug | loading dose (SC) at Week 0, followed by a single dose Q2W through Week 52 |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaofeng Cai, bachelor | Contact | 021-51371305 | xiaofeng.cai@mabgeek.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital Of China Medical University | Shenyang | China |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Placebo for MG-K10 | Drug | Initial loading dose (SC), then single dose Q2W through Week 52 |
|
| Baseline to week 52 |
| Incidence in adverse events | Baseline to week 52 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |