Phase III Study of Oral ICP-332 for Treating Moderate to Severe Atopic Dermatitis Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are studying the effects of oral ICP-332 in adults with moderate to severe atopic dermatitis, also known as atopic eczema. This randomized, double-blind, placebo-controlled phase III trial aims to evaluate how well ICP-332 works and how safe it is for people suffering from this chronic skin condition. Participants have had atopic dermatitis for at least one year and have not responded adequately to topical treatments or cannot use them for medical reasons. Participants will be randomly assigned to receive either ICP-332 tablets or placebo tablets. Both treatments are given orally as tablets. The study uses a quadruple masking method to keep participants, caregivers, investigators, and outcome assessors unaware of the assigned treatments. The main treatment period lasts 16 weeks, during which researchers will observe the changes in eczema severity and skin condition. During the study, participants will attend scheduled visits to monitor their progress, receive treatments, and undergo laboratory tests and assessments. Researchers will measure outcomes such as the proportion of participants achieving at least a 75% improvement in the Eczema Area and Severity Index and those reaching a skin assessment score indicating clear or almost clear skin. Participants must follow the treatment and visit schedule and agree to contraception if applicable. The total participation period covers the primary 16-week treatment phase and ongoing safety monitoring.

ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis