Phase 2 Study of SM17 Injection for Treating Moderate to Severe Atopic Dermatitis in Adults

What this Trial Is About

Researchers are evaluating SM17, a monoclonal antibody given by subcutaneous injection, for treating adults with moderate to severe atopic dermatitis who have not responded well or cannot tolerate certain topical treatments. This phase 2 clinical trial aims to study the effectiveness, safety, how the body processes the drug, and the immune response to SM17. The study also seeks to find the best dosing schedule for future research. Participants are randomly assigned to one of four groups receiving different doses of SM17 or a matching placebo. The treatment lasts 16 weeks during a double-blind phase, followed by an optional 4-week open-label period where all participants may receive SM17 depending on their skin condition scores. Dosages and intervals vary between groups, and participants receive subcutaneous injections throughout the study. After the treatment, a safety follow-up occurs 4 weeks after the last dose. During the study, participants will have regular assessments of their skin condition using clinical evaluations and patient questionnaires. Blood samples will be collected to monitor drug levels, immune response, and biomarkers. Safety tests, including lab work, will be performed regularly. The main outcome measured is the Eczema Area and Severity Index EASI at Week 16, with multiple other measures assessed at various timepoints up to Week 24. Total participation spans screening, treatment, and safety follow-up periods lasting several months.

A Clinical Study to Evaluate SM17 for Atopic Dermatitis