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

NCT06945458 | Completed Phase 1 FDA Drug

• 1 other identifier: KT621-AD-102
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 12

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).

Conditions

Atopic Dermatitis

Keywords

KT621; STAT6; STAT6 degrader; Targeted protein degrader; Phase 1

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Other Outcomes (8)

• KT-621 concentrations in skin

  From baseline visit through the safety follow-up visit on Day 43

• Change in Eczema Area and Severity Index (EASI) score

  From screening through the safety follow-up visit on Day 43

• Proportion of participants who achieve a validated Investigator Global Assessment (vIGA) score of 0 or 1 at scheduled clinic visits

  From screening through the safety follow-up visit on Day 43

Study Arms (1)

KT-621

EXPERIMENTAL

Each participant receives daily oral doses of KT-621 throughout the 28-day treatment period.

Drug: KT-621

Interventions

KT-621 DRUG

Oral drug

KT-621

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kymera Therapeutics, Inc.: lead

Study Sites (12)

Kymera Investigative Site

Birmingham, Alabama, 35244, United States

Location

Kymera Investigative Site

Fountain Valley, California, 92708, United States

Location

Kymera Investigative Site

Santa Monica, California, 90404, United States

Location

Kymera Investigative Site

Boynton Beach, Florida, 33436, United States

Location

Kymera Investigative Site

Hollywood, Florida, 33024, United States

Location

Kymera Investigative Site

Tampa, Florida, 33613, United States

Location

Kymera Investigative Site

Fargo, North Dakota, 58078, United States

Location

Kymera Investigative Site

Dublin, Ohio, 43016, United States

Location

Kymera Investigative Site

Springfield, Ohio, 45505, United States

Location

Kymera Investigative Site

Tulsa, Oklahoma, 74136, United States

Location

Kymera Investigative Site

Charleston, South Carolina, 29420, United States

Location

Kymera Investigative Site

San Antonio, Texas, 78213, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 25, 2025
• Study Start: April 17, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)