RecruitingAtopic Dermatitis

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

Eligible age

12–75 yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

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About this study

This phase 2b study is designed to evaluate the safety and efficacy of KT-621 in adult and adolescent 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.

Sponsor: Kymera Therapeutics, Inc.

You may qualify if…

✓ Must be 12 to 75 years of age, inclusive, at the time of signing the IAF (informed assent form) and/or ICF (informed consent form).
✓ Must have chronic AD that has been present for at least 3 years (for participants ≥ 18 years of age) or 1 year (for participants \< 18 years of age) 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 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.

You may not qualify if…

✕ 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.