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.
Eligibility
Sex
ALL
Min age
12 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
* 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.
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.
Primary outcome measure(s)
Change from baseline in Eczema Area and Severity Index (EASI) score — From baseline through Week 16
Trial sites (68)
Facility
City
Region
Status
Kymera Investigative Site
Birmingham
Alabama
Kymera Investigative Site
North Little Rock
Arkansas
Kymera Investigative Site
Freemont
California
Kymera Investigative Site
Los Angeles
California
Kymera Investigative Site
Los Angeles
California
Kymera Investigative Site
Santa Monica
California
Kymera Investigative Site
Delray Beach
Florida
Kymera Investigative Site
Jacksonville
Florida
Kymera Investigative Site
Miami
Florida
Kymera Investigative Site
Miramar
Florida
Kymera Investigative Site
Normal
Illinois
Kymera Investigative Site
Indianapolis
Indiana
Kymera Investigative Site
Ann Arbor
Michigan
Kymera Investigative Site
Detroit
Michigan
Kymera Investigative Site
The Bronx
New York
Kymera Investigative Site
Fargo
North Dakota
Kymera Investigative Site
Portland
Oregon
Kymera Investigative Site
Portland
Oregon
Kymera Investigative Site
Philadelphia
Pennsylvania
Kymera Investigative Site
San Antonio
Texas
Kymera Investigative Site
San Antonio
Texas
Kymera Investigative Site
Darlinghurst
New South Wales
Kymera Investigative Site
Kogarah
New South Wales
Kymera Investigative Site
Brisbane
Queensland
Kymera Investigative Site
Woolloongabba
Queensland
Kymera Investigative Site
Melbourne
Victoria
Kymera Investigative Site
Calgary
Alberta
Kymera Investigative Site
Edmonton
Alberta
Kymera Investigative Site
Kelowna
British Columbia
Kymera Investigative Site
Surrey
British Columbia
Kymera Investigative Site
Markham
Ontario
Kymera Investigative Site
Ottawa
Ontario
Kymera Investigative Site
Richmond Hill
Ontario
Kymera Investigative Site
Toronto
Ontario
Kymera Investigative Site
Windsor
Ontario
Kymera Investigative Site
Québec
Quebec
Kymera Investigative Site
Pardubice
Czechia
Kymera Investigative Site
Prague
Czechia
Kymera Investigative Site
Augsburg
Bavaria
Kymera Investigative Site
München
Bavaria
+ 28 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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