A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study With an Open-label Period Investigating the Efficacy and Safety Profile of KT-621 Administered Orally to Participants with Moderate to Severe Atopic Dermatitis

Condition studied

Moderate to Severe Atopic Dermatitis

Investigational medicinal product(s)

Eligibility

Primary endpoint

• Percentage change from baseline to Week 16 in the EASI score

Endpoint detail

• Proportion of participants with EASI-50, EASI-75, and EASI-90 at Week 16, • Proportion of participants who achieve a vIGA-AD score of 0 to 1 (on a 5-point scale) and a reduction from baseline of at least 2 points at Week 16, • Proportion of participants with at least a 4-point improvement in the Peak Pruritus NRS at Week 16, •Incidence of TEAEs through Week 16, • Incidence of treatment-emergent SAEs through Week 16, • Incidence of TEAEs from Week 16 through Week 68, • Incidence of treatment-emergent SAEs from Week 16 through Week 68, • Plasma PK parameter estimates of KT-621 derived from plasma concentration time data to Week 16 and Week 68