Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates the preliminary efficacy of MG-K10 in subjects with moderate to severe asthma, and provides a basis for the design and dosing regimen of phase III clinical trials.
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II study. It is planned to enroll approximately 160 adult patients with moderate-to-severe AD uncontrolled by topical therapy, who will receive multiple subcutaneous injections. The study was divided into a screening period (1-5 weeks), a treatment period (16 weeks), and a safety follow-up (8 weeks).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG-K10 Regimen 1 | Experimental | subcutaneous injection every 4 weeks (placebo injections at 2, 6, 10, 14 weeks to maintain blindness) |
|
| MG-K10 Regimen 2 | Experimental | subcutaneous injection every 2 weeks |
|
| MG-K10 Regimen 3 | Experimental | subcutaneous injection every 4 weeks (placebo injections at 2, 6, 10, 14 weeks to maintain blindness) |
|
| Placebo | Placebo Comparator | subcutaneous injection every 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MG-K10 | Drug | MG-K10 Humanized Monoclonal Antibody Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change from baseline in EASI | Percentage change from baseline in eczema area and severity index (EASI) score | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of subjects achieving EASI-75 | Proportions of subjects achieving EASI-75 (≥ 75% decrease from baseline in EASI score) at W16 | 16 weeks |
| Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline |
Not provided
key Inclusion Criteria:
Aged 18 - 70 years (inclusive), male or female;
Patients diagnosed with AD according to American Academy of Dermatology Consensus Criteria (2014) for at least 6 months prior to screening and meet the following criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jinhua Xu, Medical Ph.D | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | China | ||||
| Huashan Hospital Affiliated to Fudan University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
A Phase II Study of the Safety, Pharmacokinetics, Dose-Ranging and Preliminary Efficacy of MG-K10 Humanized Monoclonal Antibody Injection in Adult Patients with Moderate-to-Severe Atopic Dermatitis
Not provided
Not provided
Not provided
| Placebo | Drug | MG-K10 Humanized Monoclonal Antibody Injection |
|
Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline
| 2, 4, 8, 12, 16, 20 ,24 weeks |
| The change in NRS weekly | The change in NRS weekly mean score and percentage change from baseline at W2, W4, W8, W12, W16, W20, and W24 | 2, 4, 8, 12, 16, 20 ,24 weeks |
| Percentage change from baseline in EASI score | Percentage change from baseline in EASI score at Weeks W2, W4, W8, W12, W20, and W24 | 2, 4, 8, 12, 20 ,24 weeks |
| Proportions of subjects achieving EASI-50 | Proportions of subjects achieving EASI-50 (≥ 50% decrease in EASI score from baseline) at W2, W4, W8, W12, W16, W20, and W24 | 2, 4, 8, 12, 16, 20 ,24 weeks |
| Proportions of subjects achieving EASI-75 | Proportions of subjects achieving EASI-75 at W2, W4, W8, W12, W20, and W24 | 2, 4, 8, 12, 20 ,24 weeks |
| Proportions of subjects achieving EASI-90 | Proportions of subjects achieving EASI-90 (≥ 90% decrease in EASI score from baseline) at W2, W4, W8, W12, W16, W20, and W24 | 2, 4, 8, 12, 16, 20 ,24 weeks |
| Absolute change from baseline in EASI scores | Absolute change from baseline in EASI scores at W2, W4, W8, W12, W16, W20, and W24 | 2, 4, 8, 12, 16, 20 ,24 weeks |
| Absolute and percentage change from baseline in BSA score of Atopic Dermatitis | Absolute and percentage change from baseline in BSA score of Atopic Dermatitis at W2, W4, W8, W12, W16, W20, and W24 | 2, 4, 8, 12, 16, 20 ,24 weeks |
| Proportions of subjects with a decrease in IGA score from baseline of ≥ 2 | Proportions of subjects with a decrease in IGA score from baseline of ≥ 2 at W2, W4, W8, W12, W16, W20 and W24 | 2, 4, 8, 12, 16, 20 ,24 weeks |
| Proportions of subjects with a decrease in IGA score from baseline of ≥ 3 | Proportions of subjects with a decrease in IGA score from baseline of ≥ 3 at W2, W4, W8, W12, W16, W20 and W24 | 2, 4, 8, 12, 16, 20 ,24 weeks |
| Absolute change in POEM from baseline | Absolute change in patient oriented eczema measure (POEM) from baseline at W2, W4, W8, W12, W16, W20 and W24 | 2, 4, 8, 12, 16, 20 ,24 weeks |
| Absolute change in DLQI score from baseline | Absolute change in dermatology life quality index (DLQI) score from baseline at W2, W4, W8, W12, W16, W20 and W24 | 2, 4, 8, 12, 16, 20 ,24 weeks |
| Pharmacokinetic concentration | To evaluate the Pharmacokinetic concentration of MG-K10 | 24 weeks |
| thymus activation regulated chemokine (TARC) | At each evaluation time point, the changes of thymus activation regulated chemokine (TARC) were compared with baseline | 24 weeks |
| serum immunoglobulin E (IgE) | At each evaluation time point, the changes of serum immunoglobulin E (IgE)were compared with baseline | 24 weeks |
| Incidence of Adverse events (AEs) | Including vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms (ECGs) | 24 weeks |
| Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) | Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable) | 24 weeks |
| Shanghai |
| China |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |