Actively Recruiting
IB/IIa Study of MG-K10 in Adolescent Moderately Severe Patients
Led by Shanghai Mabgeek Biotech.Co.Ltd · Updated on 2025-01-09
24
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study was designed to reflect the safety pharmacokinetics and preliminary efficacy of MG-K10 Humanized Monoclonal Antibody Injection in adolescent patients 12-18 weeks of age with moderate to severe atopic dermatitis, administered every 2 or 4 weeks for 8 weeks
CONDITIONS
Official Title
IB/IIa Study of MG-K10 in Adolescent Moderately Severe Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and less than 18 years
- Body weight of at least 30 kg
- Diagnosis of atopic dermatitis meeting American Academy of Dermatology criteria
- History of atopic dermatitis or eczema for at least 6 months before screening
- Eczema Area and Severity Index (EASI) score of 16 or higher at screening and baseline
- Investigator's Global Assessment (IGA) score of 3 or higher at screening and baseline
- At least 10% of body surface area affected at screening and baseline
- Inadequate response or medical unsuitability for topical medications within 6 months prior to screening
- Agreement to use effective contraception during the study and for 6 months after last dose
- Voluntary written informed consent and ability to communicate with investigators
You will not qualify if you...
- History of severe allergic reactions to MG-K10 or similar drugs
- Inability to receive subcutaneous injections due to bleeding disorders or anticoagulant therapy
- Presence of other active skin conditions affecting evaluation (e.g., psoriasis, lupus erythematosus)
- Diseases requiring systemic hormonal or immunosuppressive therapy
- Certain ocular diseases judged inappropriate for enrollment
- Use of systemic immunosuppressants, targeted inhibitors, biologics, or ultraviolet therapy within specific timeframes before randomization
- Use of topical medications less than 2 weeks before randomization
- Participation in other clinical studies with biologics or non-biologic agents within defined timeframes
- Prior use of monoclonal antibodies targeting IL-4Rα with resistance or serious adverse effects
- Receipt of live or live-attenuated vaccines within 3 months before screening or planned during study
- Chronic active infections or recent infections requiring systemic antimicrobial therapy
- Active or untreated tuberculosis
- History of parasitic infection within 6 months
- History of malignant tumors
- Serious comorbid diseases making immunosuppressive therapy unsuitable
- Other conditions judged unsuitable by investigator
- History of alcohol or drug abuse within 6 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hangzhou First People's Hospital;
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
xiaofeng Cai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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