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 Genders
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

ArmDescriptionAssigned Intervention
Experimental
KT-621 		Each participant receives daily oral doses of KT-621 throughout the 28-day treatment period.
  • Drug: KT-621
    Oral drug

Recruiting Locations

Kymera Investigative Site
Birmingham, Alabama 35244
Contact:
Study Coordinator

Kymera Investigative Site
Santa Monica, California 90404
Contact:
Study Coordinator

Kymera Investigative Site
Boynton Beach, Florida 33436
Contact:
Study Coordinator

Kymera Investigative Site
Hollywood, Florida 33024
Contact:
Study Coordinator

Kymera Investigative Site
Tampa, Florida 33613
Contact:
Study Coordinator

Kymera Investigative Site
Fargo, North Dakota 58078
Contact:
Study Coordinator

Kymera Investigative Site
Dublin, Ohio 43016
Contact:
Study Coordinator

Kymera Investigative Site
Tulsa, Oklahoma 74136
Contact:
Study Coordinator

Kymera Investigative Site
Charleston, South Carolina 29420
Contact:
Study Coordinator

Kymera Investigative Site
San Antonio, Texas 78213
Contact:
Study Coordinator

More Details

NCT ID
NCT06945458
Status
Recruiting
Sponsor
Kymera Therapeutics, Inc.

Study Contact

Kymera Medical Director
857-285-5300
clinicaltrials@kymeratx.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center