Actively Recruiting
Study of MG-K10 Injection in Adolescents Aged 12-18 with Moderate to Severe Atopic Dermatitis Evaluating Safety, Body Effects, and Early Results with Subcutaneous Dosing Every 2 or 4 Weeks
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
Researchers are evaluating the safety, pharmacokinetics, and preliminary effectiveness of MG-K10, a humanized monoclonal antibody injection, in adolescents aged 12 to 18 years who have moderate to severe atopic dermatitis. This Phase Ib/IIa study aims to better understand how MG-K10 works in the body and its potential benefits for this condition. Participants will receive subcutaneous injections of MG-K10 once every 4 weeks for a total of 8 weeks. The study focuses on adolescents with moderate to severe symptoms who have not responded adequately to topical treatments or for whom topical treatments are not suitable. The treatment period is carefully designed to assess multiple doses and their effects. During the study, participants will undergo various assessments, including monitoring for adverse events up to 113 days, collecting pharmacokinetic and immunogenicity data, and evaluating preliminary efficacy. Researchers will also perform safety checks and follow participants closely to understand how the treatment affects their condition and overall health throughout the study period.
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
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Trial Site Locations
Total: 1 location
1
Hangzhou First People's Hospital;
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
X
xiaofeng Cai
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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