Objective
- Atopic Dermatitis (AD) is a chronic skin condition characterized by inflammation, itching, and redness. AD is an active area of drug development, with 120+ drug candidates in various stages of pre-clinical and clinical development[1].
- Quantitative Systems Pharmacology (QSP) combines mechanistic disease understanding with drug pharmacodynamics and can guide dose selection and trial design in AD.
- AD clinical trials differ in their choice of endpoints, which complicates trial design and limits comparability across studies[2]. A QSP model capable of predicting multiple endpoints could enable cross-therapeutic comparison.
- The Investigator’s Global Assessment (IGA) is a clinician-administered composite score (typical range 0-4) designed to quantify disease severity. The percentage of patients achieving IGA 0 or 1 serves as a key endpoint in trials enrolling moderate-to-severe AD patients. IGA is inherently subjective and the lack of published data directly linking IGA to disease biomarkers presents challenges for mechanistic modeling.
- We implement a machine learning strategy to overcome these limitations and integrate a population-level IGA response endpoint into an established AD QSP model.
By Anjali Mittal, Nicole Parish, Destiny A. Simpson, Ryan Suderman
ACoP 2026, October 11-14, 2026, National Harbor, Maryland