Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT06945458
Eligibility Criteria:
Inclusion Criteria:
* Participants aged 18 to 55 years (inclusive) at the time of screening
* Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures
* Participants must have had chronic atopic dermatitis (AD) for at least 1 year before Screening.
* Moderate to very severe eczema as determined by Eczema Area and Severity Index (EASI) score of at least 16 at the baseline visit.
* A validated Investigator Global Assessment (vIGA) score of at least 3 at the baseline visit, indicating moderate to severe AD.
* At least 10% body surface area (BSA) of AD involvement at the baseline visit.
* Weekly average Peak Pruritus Numeric Rating Scale (NRS) of at least 4 at the baseline visit.
* Documented history within 6 months prior to baseline visit of either inadequate response or contraindication to topical medications for AD.
* Application of stable dose of moisturizer at least twice daily for at least 7 consecutive days immediately prior to the baseline visit.
Exclusion Criteria:
* Participants who 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.
* Participants who have any surgical or medical procedure planned during participation in the study.
* Participants with a history of alcohol or substance abuse within the previous 2 years.
* Participants who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results.
* Participants whose results from clinical laboratory safety tests are outside the local reference range at Screening.
* Participants who 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.
* Participants with 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.
* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
* Female participants of childbearing potential with a positive or undetermined pregnancy result at the Screening and baseline visits.
* Participants with a known sensitivity to any of the components of KT-621.
* Participants who are a member of the investigational team or his/her immediate family.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06945458
Study Brief:
Protocol Section:
NCT06945458