This study is a 2-part (parts A and B) study.The primary objective of the study is to evaluate the efficacy of 611 in Chinese Children with moderate to severe atopic dermatitis (AD).
The participants and their legally acceptable representatives are able to understand and comply with the research procedures, agree to participate in the research, and sign the Informed Consent Form (ICF) ;
When signing the informed consent form, the age should be ≥ 2 years old and < 6 years old for part A, and ≥ 2 years old and < 12 years old for part B. any gender, with body weight ≥ 15 kg at baseline;
During the screening process, patients were diagnosed with atopic dermatitis (AD) according to the Hanifin - Rajka criteria, and their AD medical history was evaluated by researchers to be ≥ 6 months for participants aged ≥2 years to <6 years, ≥ 3 months for participants aged ≥6 years to <12 years;
At the screening and baseline, the Eczema Area and Severity Index (EASI) score is ≥ 16 points;
Intolerance to TCS / TCI treatment or contraindications to TCS / TCI;
Merge other skin comorbidities that may interfere with the research evaluation;
Combined with active parasitic infections (such as helminths) or suspected parasitic infections ;
Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC) ;
Parallel
611
DrugSolution for injection, subcutaneous (SC)
611
DrugSolution for injection, subcutaneous (SC)
Matching placebo
DrugSolution for injection, subcutaneous (SC)
Part A: drug concentration.
concentration of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) .
Part B: Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 18.
The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Part B: Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points From Baseline to Week 18.
The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
Part A: Adverse events (AEs), measurement of vital signs, physical examination, electrocardiogram and laboratory tests at each visit.
The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations, electrocardiogram, laboratory tests and, etc.
Part A: Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at each efficacy evaluation visit point.
The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Part A: Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Improvement From Baseline of Greater Than or Equal to (>=) 2 Points From Baseline to each efficacy evaluation visit point.
The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
Part A: Number of Participants With EASI-50 (>=50% Improvement From Baseline).
The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
Part B: drug concentration.
concentration of 611.
Part B: Percentage of Participants With Anti-drug Antibodies and Neutralizing Antibodies.
Immunogenicity assessment will be based on Anti-drug Antibodies (ADAs) response and development of Neutralizing Antibodies (NABs). Percentage is calculated based on the number of evaluable participants and calculated by number of participants with treatment-emergent positive anti-drug antibodies / number of evaluable participants \* 100%.
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