A Phase II Clinical Study Evaluating of ZL-82 Tablets in Atopic Dermatitis
Trial Parameters
Brief Summary
This clinical trial aims to explore whether the drug ZL-82 tablets can be used to treat moderate to severe atopic dermatitis in adults, and to understand the safety and tolerability of the drug. The main questions that the trial intends to answer are: Can ZL-82 tablets alleviate the Eczema Area and Severity Index (EASI) score of patients? What physical problems will patients have after taking ZL-82 tablets? The researchers will compare ZL-82 tablets with placebo (a substance with a similar appearance but without drug components) to observe whether ZL-82 tablets can be used to treat moderate to severe atopic dermatitis. Participants need to take ZL-82 tablets or placebo every day for 16 weeks, and visit the hospital for a check-up every two weeks; record their own symptoms and the percentage change of EASI score relative to the baseline.
Eligibility Criteria
Inclusion Criteria: 1. Male or female individuals aged 18 years and above and 75 years and below (inclusive of the threshold value, based on the date of signing the ICF), with BMI \>= 19 kg/m2. 2. Participants are fully informed of the purpose and requirements of this trial, and voluntarily sign the informed consent form. 3. According to the Hanifin \& Rajka diagnostic criteria (≥ 3 out of 4 main 4, \>= 3 out of 23 secondary symptoms, see Appendix 1), diagnosed as AD by the investigators, and with a history of AD for \>= 1 year before screening. 4 . The definition of moderate to severe atopic dermatitis during screening and baseline period is as follows: 1. IGA score of 3 or 4; 2. EASI score \>= 16; 3. Average peak pruritus NRS score \>= 4 in the past week (Note: The NRS average value is the average of the maximum NRS score of pruritus intensity over 7 consecutive days before baseline, with a score range of 0-10 for each day. At least 4 days of scores are required for the calculation o