The company said the multi-week review finalized the Stage 2 protocol by refining patient selection, disease stratification, efficacy endpoints, and statistical methodology.
Based on the findings, the ongoing study will now prospectively evaluate patients across the full spectrum of baseline disease severity measured by the Eczema Area and Severity Index, or EASI.
Interim Analysis Shapes Final Study Design
The interim review followed the company’s previously disclosed analysis of the first 50 completed patients and was conducted under the oversight of the Independent Data Monitoring Committee.
According to the company, enrollment continued without interruption during the review, with all newly enrolled patients remaining blinded and included in the final Stage 2 analysis.
