A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis

Exclusion Criteria

• •Must not have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the Investigator in the 4 weeks before the baseline visit.
• •Must not have other skin conditions, such as contact dermatitis, psoriasis, tinea corporis, or lupus erythematosus, that may interfere with study assessments.
• •Must not have a clinically relevant history of respiratory, gastrointestinal (GI), renal, hepatic, hematological, lymphatic, endocrinological, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, ophthalmological, or connective tissue diseases or disorders.
• •Must not have any surgical or medical procedure planned during participation in the study.
• •Must not have a history of alcohol or substance abuse within the previous 2 years.
• •Must not be pregnant or breastfeeding; must not be a woman planning to become pregnant or breastfeed during the study.
• •Must not have a history of lack of response to any medication targeting interleukin (IL)-4, IL-13, and/or janus kinase (JAK)- signal transducer and activator of transcription (STAT) pathways (e.g. dupilumab, tralokinumab, upadacitinib, abrocitinib) at approved doses after at least 16 weeks of therapy.
• •Must not have results from clinical laboratory safety tests that are outside the local reference range at Screening.
• •Must not have been dosed with any investigational drug or device in a clinical study within 8 weeks or 5 half-lives (whichever is longer) of KT-621 administration.
• •Female participants of childbearing potential must not have a positive or undetermined pregnancy result at the Screening and baseline visits.
• •Must not have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results.
• •Must not be taking or have taken any prespecified prohibited therapies within a specific timeframe as evaluated by the Investigator.
• •Must not have a known sensitivity to any of the components of KT-621.
• •Must not be a member of the investigational team or his/her immediate family.