Atopic Dermatitis
Conditions
Keywords
Atopic dermatitis
Brief summary
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.
Detailed description
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).
Interventions
DRUGMG-K10
MG-K10 Humanized Monoclonal Antibody Injection
DRUGPlacebo
MG-K10 Humanized Monoclonal Antibody Injection
Sponsors
Shanghai Mabgeek Biotech.Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
key Inclusion Criteria: 1. Aged 18 - 70 years (inclusive), male or female; 2. 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: * EASI score ≥ 16 at the screening and baseline visits; * IGA score ≥ 3 at the screening and baseline visits; * AD affected body surface area (BSA) percent ≥10% at the screening and baseline visits; * Documented recent history (within 6 months before the screening) of inadequate response to treatment with potent topical corticosteroids for at least 4 weeks or super-potent topical corticosteroids for at least 2 weeks, or topical calcineurin inhibitors for 4 weeks, or prior systemic use of corticosteroids or immunosuppressive agents for more than 2 weeks; Key
Exclusion criteria
1. Subjects currently diagnosed with other active skin disorders (e.g., psoriasis or lupus erythematosus) that may affect AD evaluation; 2. Subjects with concomitant diseases that may require systemic hormone therapy or other interventions or require active and frequent monitoring; 3. Subjects with unstable or not well controlled apparent cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological and psychological diseases that is considered by the investigator to be clinically significant； 4. Patients with ocular diseases that are not suitable for enrollment by the investigator； 5. Use of biological agents within 12 weeks prior to randomization or within 5 half-lives (whichever is longer)； 6. Use of topical corticosteroids, topical calcineurin inhibitors, antibiotic compound cream and other topical products for AD treatment within 1 week prior to randomization; 7. chest X-ray or CT examination within 3 months prior to screening/during the screening period suggests the presence of active tuberculosis infection； 8. History of parasitic infection or travel to endemic areas (South America and Africa) half a year prior to screening。
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change from baseline in EASI | 16 weeks | Percentage change from baseline in eczema area and severity index (EASI) score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) | 24 weeks | Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (Nabs) (if applicable) |
| Proportions of subjects achieving EASI-75 | 16 weeks | Proportions of subjects achieving EASI-75 (≥ 75% decrease from baseline in EASI score) at W16 |
| 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 | Proportions of subjects achieving IGA score of 0/1 point and a decrease of ≥ 2 points from baseline |
| The change in NRS weekly | 2, 4, 8, 12, 16, 20 ,24 weeks | The change in NRS weekly mean score and percentage change from baseline at W2, W4, W8, W12, W16, W20, and W24 |
| Percentage change from baseline in EASI score | 2, 4, 8, 12, 20 ,24 weeks | Percentage change from baseline in EASI score at Weeks W2, W4, W8, W12, W20, and W24 |
| Proportions of subjects achieving EASI-50 | 2, 4, 8, 12, 16, 20 ,24 weeks | Proportions of subjects achieving EASI-50 (≥ 50% decrease in EASI score from baseline) at W2, W4, W8, W12, W16, W20, and W24 |
| Proportions of subjects achieving EASI-90 | 2, 4, 8, 12, 16, 20 ,24 weeks | Proportions of subjects achieving EASI-90 (≥ 90% decrease in EASI score from baseline) at W2, W4, W8, W12, W16, W20, and W24 |
| Absolute change from baseline in EASI scores | 2, 4, 8, 12, 16, 20 ,24 weeks | Absolute change from baseline in EASI scores at W2, W4, W8, W12, W16, W20, and W24 |
| Incidence of Adverse events (AEs) | 24 weeks | Including vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms (ECGs) |
| Proportions of subjects with a decrease in IGA score from baseline of ≥ 2 | 2, 4, 8, 12, 16, 20 ,24 weeks | Proportions of subjects with a decrease in IGA score from baseline of ≥ 2 at W2, W4, W8, W12, W16, W20 and W24 |
| Proportions of subjects with a decrease in IGA score from baseline of ≥ 3 | 2, 4, 8, 12, 16, 20 ,24 weeks | Proportions of subjects with a decrease in IGA score from baseline of ≥ 3 at W2, W4, W8, W12, W16, W20 and W24 |
| Absolute change in POEM from baseline | 2, 4, 8, 12, 16, 20 ,24 weeks | Absolute change in patient oriented eczema measure (POEM) from baseline at W2, W4, W8, W12, W16, W20 and W24 |
| Absolute change in DLQI score from baseline | 2, 4, 8, 12, 16, 20 ,24 weeks | Absolute change in dermatology life quality index (DLQI) score from baseline at W2, W4, W8, W12, W16, W20 and W24 |
| Pharmacokinetic concentration | 24 weeks | To evaluate the Pharmacokinetic concentration of MG-K10 |
| thymus activation regulated chemokine (TARC) | 24 weeks | At each evaluation time point, the changes of thymus activation regulated chemokine (TARC) were compared with baseline |
| serum immunoglobulin E (IgE) | 24 weeks | At each evaluation time point, the changes of serum immunoglobulin E (IgE)were compared with baseline |
| Absolute and percentage change from baseline in BSA score of Atopic Dermatitis | 2, 4, 8, 12, 16, 20 ,24 weeks | Absolute and percentage change from baseline in BSA score of Atopic Dermatitis at W2, W4, W8, W12, W16, W20, and W24 |
Countries
China
Outcome results
None listed