Atopic Dermatitis
Conditions
Keywords
KT621, STAT6, STAT6 degrader, Targeted protein degrader, Phase 1
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 atopic dermatitis (AD).
Interventions
DRUGKT-621
Oral drug
Sponsors
Kymera Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) | From enrollment through the safety follow-up visit on Day 43 |
| Incidence of treatment-emergent potentially clinically-significant abnormalities in electrocardiogram (ECG) results, vital signs, or laboratory test results from the serum chemistry, hematology (with differential), chemistry, or coagulation panels. | From enrollment through the safety follow-up visit on Day 43 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma PK parameter estimates of KT-621 derived from plasma concentration-time data | From baseline visit through the safety follow-up visit on Day 43 | Trough concentrations taken at each visit before dosing, post-dose concentrations taken after dosing at Days 1 and 15. |
Countries
United States
Outcome results
None listed