Status:
ACTIVE_NOT_RECRUITING
Safety, PK, PD, and Clinical Activity of Orally Administered KT-621 in Adult Patients With Atopic Dermatitis (AD)
Lead Sponsor:
Kymera Therapeutics, Inc.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of orally administered KT-621 in adult male and female patients with moderate to severe atop...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06945458
Start Date
April 17 2025
End Date
December 1 2025
Last Update
October 6 2025
Active Locations (12)
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1
Kymera Investigative Site
Birmingham, Alabama, United States, 35244
2
Kymera Investigative Site
Fountain Valley, California, United States, 92708
3
Kymera Investigative Site
Santa Monica, California, United States, 90404
4
Kymera Investigative Site
Boynton Beach, Florida, United States, 33436