Evaluation of 611 in Chinese Children With Moderate to Severe Atopic Dermatitis(AD)

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-11
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

About this trial

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

Qualifiers

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;

Disqualifiers

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) ;

Trial design

Treatments tested in this trial

  • 611
  • 611
  • Matching placebo

Treatment groups

246 Participants
are divided into 3 treatment groups