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
This phase 2b study is designed to evaluate the safety and efficacy of KT-621 in participants with moderate-to-severe atopic dermatitis (AD), a common form of eczema. The main goals of this study are to learn how effective KT-621 is at reducing the severity and extent of AD, the safety and tolerability of KT-621, how KT-621 behaves in the body, and how the body responds to KT-621. This is a 16-week double-blind, placebo-controlled study with a 52-week open-label period.
• Must be 18 years (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age, inclusive, at the time of signing the ICF.
• Must have chronic AD that has been present for at least 3 years before the Screening visit.
• Must have an EASI score ≥ 16 at the Screening and Baseline visits.
• Must have a vIGA-AD score ≥ 3 (scale of 0 to 4) at the Screening and Baseline visits.
• Must have at least 10% BSA of AD involvement at the Screening and Baseline visits.
• Must have a weekly average Peak Pruritus NRS value ≥ 4 at the Baseline visit.
• Must have a documented history within the 6 months prior to the Baseline visit of either an inadequate response to, or inability to take, topical medications for the treatment of AD.
• Must apply a stable dose of moisturizer at least twice daily for at least 7 consecutive days immediately prior to the Baseline visit. Participants should be willing to continue using moisturizer twice daily during the study.
• Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, other study-related procedures, and questionnaires, including completing the electronic diary (e-diary), for the duration of the study as required by the study protocol.
• Must agree to contraceptive requirements in compliance with the clinical study and local requirements.