COMPLETED

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

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Conditions

Atopic DermatitisKT621STAT6STAT6 degraderTargeted protein degraderPhase 1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase 1b Open-label, Multicenter, Single-arm Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered KT-621 in Adult Participants With Moderate to Severe Atopic Dermatitis

Quick Facts

Study Start:2025-04-17
Study Completion:2025-11-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06945458

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants aged 18 to 55 years (inclusive) at the time of screening
  2. * Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures
  3. * Participants must have had chronic atopic dermatitis (AD) for at least 1 year before Screening.
  4. * Moderate to very severe eczema as determined by Eczema Area and Severity Index (EASI) score of at least 16 at the baseline visit.
  5. * A validated Investigator Global Assessment (vIGA) score of at least 3 at the baseline visit, indicating moderate to severe AD.
  6. * At least 10% body surface area (BSA) of AD involvement at the baseline visit.
  7. * Weekly average Peak Pruritus Numeric Rating Scale (NRS) of at least 4 at the baseline visit.
  8. * Documented history within 6 months prior to baseline visit of either inadequate response or contraindication to topical medications for AD.
  9. * Application of stable dose of moisturizer at least twice daily for at least 7 consecutive days immediately prior to the baseline visit.
  1. * 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.
  2. * Participants who have any surgical or medical procedure planned during participation in the study.
  3. * Participants with a history of alcohol or substance abuse within the previous 2 years.
  4. * Participants who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results.
  5. * Participants whose results from clinical laboratory safety tests are outside the local reference range at Screening.
  6. * 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.
  7. * 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.
  8. * Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
  9. * Female participants of childbearing potential with a positive or undetermined pregnancy result at the Screening and baseline visits.
  10. * Participants with a known sensitivity to any of the components of KT-621.
  11. * Participants who are a member of the investigational team or his/her immediate family.

Contacts and Locations

Study Locations (Sites)

Kymera Investigative Site
Birmingham, Alabama, 35244
United States
Kymera Investigative Site
Fountain Valley, California, 92708
United States
Kymera Investigative Site
Santa Monica, California, 90404
United States
Kymera Investigative Site
Boynton Beach, Florida, 33436
United States
Kymera Investigative Site
Hollywood, Florida, 33024
United States
Kymera Investigative Site
Tampa, Florida, 33613
United States
Kymera Investigative Site
Fargo, North Dakota, 58078
United States
Kymera Investigative Site
Dublin, Ohio, 43016
United States
Kymera Investigative Site
Springfield, Ohio, 45505
United States
Kymera Investigative Site
Tulsa, Oklahoma, 74136
United States
Kymera Investigative Site
Charleston, South Carolina, 29420
United States
Kymera Investigative Site
San Antonio, Texas, 78213
United States

Collaborators and Investigators

Sponsor: Kymera Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-17
Study Completion Date2025-11-10

Study Record Updates

Study Start Date2025-04-17
Study Completion Date2025-11-10

Terms related to this study

Keywords Provided by Researchers

  • KT621
  • STAT6
  • STAT6 degrader
  • Targeted protein degrader
  • Phase 1

Additional Relevant MeSH Terms

  • Atopic Dermatitis