A Phase Ic/II Clinical Study to Explore the Safety, Tolerability, Efficacy, and Pharmacokinetics of Multiple Oral Doses of LT-002-158 Tablets in Chinese Adult Subjects With Atopic Dermatitis
This study is an Ic/II phase clinical trial conducted in Chinese subjects with moderate to severe atopic dermatitis. The phase Ic study is a randomized, open label, parallel group design, mainly evaluating the safety and tolerability of LT-002-158 tablets in subjects with moderate to severe atopic dermatitis. The phase II study is a randomized, double-blind, placebo-controlled, parallel group design, with a single arm design for extended treatment, mainly exploring the efficacy of LT-002-158 tablets in the treatment of moderate to severe atopic dermatitis subjects.
• When signing the informed consent form, the age range is 18 to 75 years old (including threshold), and there is no gender limit.
• Body mass index (BMI) is between 17.5 and 40.0 kg/m2 (inclusive), with a weight of ≥ 45.0 kg.
• Insufficient response or intolerance to topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within the last 6 months of randomization; Insufficient response is defined as the failure to achieve and maintain remission or low disease activity (equivalent to vIGA 0=complete clearance to 2=mild) despite the use of a moderate to high efficacy TCS regimen (± TCI if applicable) for at least 28 days or the longest duration recommended in the drug prescription information (e.g. 14 days for super potent TCS), whichever is shorter.
• Subjects must use topical moisturizers (moisturizers) daily for at least 7 consecutive days prior to the baseline visit. Participants should continue to use daily moisturizers during the study period.
• Female and male participants with fertility and their partners had no fertility plans during the study period and within 6 months after the last dose, and agreed to take effective contraceptive measures.
• Understand and voluntarily sign written informed consent; Willing and able to complete planned visits, treatments, examinations, and other procedures (such as dietary requirements, diary card recording, and collection) according to the requirements of the plan.