Evaluation of 611 in Chinese Adolescents With Moderate to Severe Atopic Dermatitis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-17
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

About this trial

The primary objective of the study was to evaluate the efficacy of 611 in Chinese Adolescents with moderate to severe atopic dermatitis.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • 611
  • Matching placebo

Treatment groups

180 Participants
are divided into 2 treatment groups