The primary objective of the study was to evaluate the efficacy of 611 in Chinese Adolescents with moderate to severe atopic dermatitis.
The subjects and their legal guardians 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 ≥ 12 years old and < 18 years old, gender is not restricted, and the body weight should be ≥ 30 kg at the screening and 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 (the diagnostic criteria are not restricted for the medical history).
At the screening and baseline, the Eczema Area and Severity Index (EASI) score is ≥ 16 points.
Merge other skin comorbidities that may interfere with the research evaluation.
Combined with active parasitic infections (such as helminths) or suspected parasitic infections (subjects who have excluded active infections through clinical and/or laboratory examinations before randomization can be enrolled).
Any history of vernal keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC).
Randomly select patients with any malignant tumor diagnosed within the past 5 years or currently having the disease (excluding basal cell carcinoma that has been cured for ≥ 1 year, local cutaneous squamous cell carcinoma, or carcinoma in situ of the cervix).
Parallel
611
DrugDouble blind treatment period : 611 600 mg/450 mg at day 1，then 300 mg subcutaneous injection Q2W thereafter until week 16 Maintenance treatment period : 611 300 mg subcutaneous injection Q2W/Q3W until week 52.（The subjects in the placebo group during the double-blind treatment period need to be given a loading dose at week 16.）
Matching placebo
DrugDouble blind treatment period : placebo subcutaneous injection Q2W until week 16.
Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at Week 16
The EASI score was 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
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 16
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
Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Improvement in Score From Baseline) at each efficacy evaluation visit point except for Week 16
The EASI score was 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
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 except for Week 16
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.
Number of Participants With EASI-50 (>=50% Improvement From Baseline)
The EASI score was 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.
Number of Participants With EASI-90 (>=90% Improvement From Baseline)
The EASI score was 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
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.
Minimum concentration (Cmin)
Minimum concentration (Cmin) of 611
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 was calculated by number of participants with treatment-emergent positive anti-drug antibodies / number of evaluable participants \* 100%
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