Safety, PK, PD, and Clinical Activity of Orally Administered KT-621 in Adult Patients With Atopic Dermatitis (AD)
Purpose
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).
Condition
- Atopic Dermatitis
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- All
- Accepts 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental KT-621 |
Each participant receives daily oral doses of KT-621 throughout the 28-day treatment period. |
|
Recruiting Locations
More Details
- NCT ID
- NCT06945458
- Status
- Completed
- Sponsor
- Kymera Therapeutics, Inc.