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Recruiting
NCT07767253
Evaluation of 611 in Chinese Children With Moderate to Severe Atopic Dermatitis(AD)
Conditions: Dermatitis, Atopic
Sex: All
Ages: 2 Years – 11 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 246
Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Location: Beijing Children's Hospital, Capital Medical University Beijing Beijing Municipality
Summary
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).
Eligibility Criteria
Inclusion Criteria:
1. 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) ;
2. 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;
3. 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 \
Source: ClinicalTrials.gov (NCT07767253). StuddyBuddy aggregates publicly available trial information.