A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis (NCT07217015)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (15 items).
Location: Kymera Investigative Site โ Birmingham, Alabama
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (68 Sites)
- Kymera Investigative Site โ Birmingham, Alabama
- Kymera Investigative Site โ North Little Rock, Arkansas
- Kymera Investigative Site โ Freemont, California
- Kymera Investigative Site โ Los Angeles, California
- Kymera Investigative Site โ Los Angeles, California
- Kymera Investigative Site โ Santa Monica, California
- Kymera Investigative Site โ Delray Beach, Florida
- Kymera Investigative Site โ Jacksonville, Florida
- Kymera Investigative Site โ Miami, Florida
- Kymera Investigative Site โ Miramar, Florida
- Kymera Investigative Site โ Normal, Illinois
- Kymera Investigative Site โ Indianapolis, Indiana
- Kymera Investigative Site โ Ann Arbor, Michigan
- Kymera Investigative Site โ Detroit, Michigan
- Kymera Investigative Site โ The Bronx, New York
- Kymera Investigative Site โ Fargo, North Dakota
- Kymera Investigative Site โ Portland, Oregon
- Kymera Investigative Site โ Portland, Oregon
- Kymera Investigative Site โ Philadelphia, Pennsylvania
- Kymera Investigative Site โ San Antonio, Texas
- Kymera Investigative Site โ San Antonio, Texas
- Kymera Investigative Site โ Darlinghurst, New South Wales
- Kymera Investigative Site โ Kogarah, New South Wales
- Kymera Investigative Site โ Brisbane, Queensland
- Kymera Investigative Site โ Woolloongabba, Queensland
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.