Safety, PK, PD, and Clinical Activity of Orally Administered KT-621 in Adult Patients With Atopic Dermatitis (AD)

Launched by KYMERA THERAPEUTICS, INC. · Apr 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new oral medication called KT-621 to see how safe it is and how well it works for adults with moderate to severe atopic dermatitis (AD), which is a chronic skin condition that causes itchy and inflamed skin. The trial aims to understand how the body absorbs the medication, how it affects the condition, and the overall clinical activity of KT-621. It is currently not yet recruiting participants, but once it starts, it will focus on adults aged 18 to 55 who have had chronic atopic dermatitis for at least a year and have significant symptoms.

To be eligible for the trial, participants need to have a specific level of severity in their eczema, demonstrated by a scoring system, and must show that previous treatments have not worked for them. The study will require participants to follow a treatment plan and attend regular visits for check-ups. It’s important to note that certain individuals, such as those with specific health issues, pregnant or breastfeeding women, or those who have recently participated in another clinical study, may not qualify. Participants can expect to receive close monitoring throughout the trial to ensure their safety and to gather important data about the medication's effects.

Gender

ALL

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.