Atopic Dermatitis (AD)
Conditions
Brief summary
This study is a multicenter, randomized, double-blind, parallel controlled phase II study. It is planned to include approximately 60 subjects with moderate to severe atopic dermatitis(AD) to evaluate the efficacy and safety of MG-K10 monotherapy in adult patients with moderate to severe AD, and to observe PK characteristics, PD effects and immunogenicity.
Interventions
DRUGMG-K10/Placebo
To ensure blinding, 4 mL of placebo will be administered subcutaneously at Weeks 4, 12 and 20., for a total of 3 doses.
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
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. AD patients diagnosed in accordance with the consensus criteria of the American Academy of Dermatology (2014) had a history of AD or eczema diagnosis of ≥1 year 2. The patient's response to topical medication treatment is insufficient, or it is medically inappropriate to use topical medication for treatment 3. The subjects and their partners agreed to take effective contraceptive measures from signing the Informed Consent Form (ICF) until 6 months after the end of treatment, and had no plans for childbirth, sperm donation or egg donation
Exclusion criteria
1. The subject currently has a diagnosis of other active skin diseases (such as psoriasis or lupus erythematosus) that may affect the evaluation of AD 2. Patients with eye diseases that the researchers judged as unsuitable for inclusion 3. Patients with malignant tumors within 5 years 4. There is evidence of active tuberculosis, or there has been evidence of active tuberculosis before and no appropriate documented treatment has been received 5. Confirm active parasitic infection 6. Those with active hepatitis, or positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb), or positive for hepatitis C virus (HCV) antibody, or positive for HIV antibody, or positive for (TP-Ab) 7. Women who are breastfeeding or pregnant, or women planning to become pregnant or breastfeed during the study period 8. Those who the researchers consider to have other circumstances that make them unsuitable to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of subjects reaching EASI-75 at 24 weeks of treatment | 24 weeks | The percentage of subjects reaching EASI-75 at 24 weeks of treatment |
| The percentage of subjects who achieved the IGA score standard at 24 weeks of treatment | 24 weeks | The percentage of subjects whose IGA score reached 0 or 1 at 24 weeks of treatment (W24) and decreased by ≥2 points compared with the baseline; |
Countries
China
Outcome results
None listed