A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis

NCT07217015 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: KT621-AD-2012025-522370-36-00
• Study Type: interventional
• Target: 200
• Locations: 8 countries
• Sites: 61

Brief Summary

This phase 2b study is designed to evaluate the safety and efficacy of KT-621 in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD), a common form of eczema. The main goals of this study are to learn how effective KT-621 is at reducing the severity and extent of AD, the safety and tolerability of KT-621, how KT-621 behaves in the body, and how the body responds to KT-621. This is a 16-week double-blind, placebo-controlled study with a 52-week open-label period.

Conditions

Atopic Dermatitis

Keywords

STAT6; stat6 degrader; targeted protein degrader; Phase 2; Phase 2b; kt-621

Outcome Measures

Primary Outcomes (1)

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

  From baseline through Week 16

Secondary Outcomes (12)

• Incidence of treatment-emergent adverse events (TEAEs)

  From baseline through Week 16, and from Week 16 through Week 68

• Incidence of treatment-emergent serious adverse events (SAEs)

  From baseline through Week 16, and from Week 16 through Week 68

• Percentage change from baseline in body surface area (BSA) affected by AD

  From baseline to Week 16 and to Week 68

• Percentage change from baseline in the Peak Pruritus NRS score

  From baseline to Week 16, and to Week 68

• Proportion of participants with at least a 4-point improvement from baseline in the Peak Pruritus Numerical Rating Scale (NRS)

  At Week 16 and at Week 68

Study Arms (4)

Group 1: KT-621 Dose 1

EXPERIMENTAL

Drug: KT-621

Group 2: KT-621 Dose 2

EXPERIMENTAL

Drug: KT-621

Group 3: KT-621 Dose 3

EXPERIMENTAL

Drug: KT-621

Group 4: Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

KT-621 DRUG

Oral drug

Group 1: KT-621 Dose 1; Group 2: KT-621 Dose 2; Group 3: KT-621 Dose 3

Placebo OTHER

Oral placebo matched to KT-621

Group 4: Placebo

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 12 to 75 years of age, inclusive, at the time of signing the IAF (informed assent form) and/or ICF (informed consent form).
• Must have chronic AD that has been present for at least 3 years (for participants ≥ 18 years of age) or 1 year (for participants \< 18 years of age) before the Screening visit.
• Must have an EASI score ≥ 16 at the Screening and Baseline visits.
• Must have a vIGA-AD score ≥ 3 (scale of 0 to 4) at the Screening and Baseline visits.
• Must have at least 10% BSA of AD involvement at the Screening and Baseline visits.
• Must have a weekly average Peak Pruritus NRS value ≥ 4 at the Baseline visit.
• Must have a history within the 6 months prior to the Baseline visit of either an inadequate response to, or inability to take, topical medications for the treatment of AD.
• Must apply a stable dose of moisturizer at least twice daily for at least 7 consecutive days immediately prior to the Baseline visit. Participants should be willing to continue using moisturizer twice daily during the study.
• Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, other study-related procedures, and questionnaires, including completing the electronic diary (e-diary), for the duration of the study as required by the study protocol.
• Must agree to contraceptive requirements in compliance with the clinical study and local requirements.

You may not qualify if:

• Must not have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the Investigator in the 4 weeks before the baseline visit.
• Must not have other skin conditions, such as contact dermatitis, psoriasis, tinea corporis, or lupus erythematosus, that may interfere with study assessments.
• Must not 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.
• Must not have any surgical or medical procedure planned during participation in the study.
• Must not have a history of alcohol or substance abuse within the previous 2 years.
• Must not be pregnant or breastfeeding; must not be a woman planning to become pregnant or breastfeed during the study.
• Must not have 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.
• Must not have results from clinical laboratory safety tests that are outside the local reference range at Screening.
• Must not 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.
• Female participants of childbearing potential must not have a positive or undetermined pregnancy result at the Screening and baseline visits.
• Must not have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results.
• Must not be taking or have taken any prespecified prohibited therapies within a specific timeframe as evaluated by the Investigator.
• Must not have a known sensitivity to any of the components of KT-621.
• Must not be a member of the investigational team or his/her immediate family.

Sponsors & Collaborators

• Kymera Therapeutics, Inc.: lead

Study Sites (61)

Kymera Investigative Site

Birmingham, Alabama, 35244, United States

RECRUITING

Kymera Investigative Site

North Little Rock, Arkansas, 72117, United States

RECRUITING

Kymera Investigative Site

Freemont, California, 94538, United States

RECRUITING

Kymera Investigative Site

Los Angeles, California, 90025, United States

RECRUITING

Kymera Investigative Site

Los Angeles, California, 90045, United States

RECRUITING

Kymera Investigative Site

Santa Monica, California, 91350, United States

RECRUITING

Kymera Investigative Site

Delray Beach, Florida, 33484, United States

RECRUITING

Kymera Investigative Site

Miami, Florida, 33137, United States

RECRUITING

Kymera Investigative Site

Miramar, Florida, 33027, United States

RECRUITING

Kymera Investigative Site

Normal, Illinois, 61761, United States

RECRUITING

Kymera Investigative Site

Indianapolis, Indiana, 46202, United States

RECRUITING

Kymera Investigative Site

Ann Arbor, Michigan, 48103, United States

RECRUITING

Kymera Investigative Site

Detroit, Michigan, 48202, United States

RECRUITING

Kymera Investigative Site

The Bronx, New York, 10455, United States

RECRUITING

Kymera Investigative Site

Fargo, North Dakota, 58103, United States

RECRUITING

Kymera Investigative Site

Portland, Oregon, 97201, United States

RECRUITING

Kymera Investigative Site

Portland, Oregon, 97239, United States

RECRUITING

Kymera Investigative Site

Philadelphia, Pennsylvania, 19103, United States

RECRUITING

Kymera Investigative Site

San Antonio, Texas, 78213, United States

RECRUITING

Kymera Investigative Site

San Antonio, Texas, 78218, United States

RECRUITING

Kymera Investigative Site

Darlinghurst, New South Wales, Australia

RECRUITING

Kymera Investigative Site

Kogarah, New South Wales, Australia

RECRUITING

Kymera Investigative Site

Brisbane, Queensland, Australia

RECRUITING

Kymera Investigative Site

Woolloongabba, Queensland, Australia

RECRUITING

Kymera Investigative Site

Melbourne, Victoria, Australia

RECRUITING

Kymera Investigative Site

Calgary, Alberta, Canada

RECRUITING

Kymera Investigative Site

Edmonton, Alberta, Canada

RECRUITING

Kymera Investigative Site

Kelowna, British Columbia, Canada

RECRUITING

Kymera Investigative Site

Surrey, British Columbia, Canada

RECRUITING

Kymera Investigative Site

Markham, Ontario, Canada

RECRUITING

Kymera Investigative Site

Ottawa, Ontario, Canada

RECRUITING

Kymera Investigative Site

Richmond Hill, Ontario, Canada

RECRUITING

Kymera Investigative Site

Toronto, Ontario, Canada

RECRUITING

Kymera Investigative Site

Québec, Quebec, Canada

RECRUITING

Kymera Investigative Site

Pardubice, Czechia

RECRUITING

Kymera Investigative Site

Prague, Czechia

RECRUITING

Kymera Investigative Site

Augsburg, Bavaria, Germany

RECRUITING

Kymera Investigative Site

München, Bavaria, Germany

RECRUITING

Kymera Investigative Site

Bad Bentheim, Germany

RECRUITING

Kymera Investigative Site

Berlin, Germany

RECRUITING

Kymera Investigative Site

Dresden, Germany

RECRUITING

Kymera Investigative Site

Mainz, Germany

RECRUITING

Kymera Investigative Site

Ichikawa, Chiba, Japan

RECRUITING

Kymera Investigative Site

Kagoshima, Japan

RECRUITING

Kymera Investigative Site

Kanagawa, Japan

RECRUITING

Kymera Investigative Site

Osaka, Japan

RECRUITING

Kymera Investigative Site

Sakai, Japan

RECRUITING

Kymera Investigative Site

Chorzów, Poland

RECRUITING

Kymera Investigative Site

Gdansk, Poland

RECRUITING

Kymera Investigative Site

Gdynia, Poland

RECRUITING

Kymera Investigative Site

Krakow, Poland

RECRUITING

Kymera Investigative Site

Lublin, Poland

RECRUITING

Kymera Investigative Site

Rzeszów, Poland

RECRUITING

Kymera Investigative Site

Szczecin, Poland

RECRUITING

Kymera Investigative Site

Warsaw, Poland

RECRUITING

Kymera Investigative Site

Wroclaw, Poland

RECRUITING

Kymera Investigative Site

Ansan-si, South Korea

RECRUITING

Kymera Investigative Site

Cheonan, South Korea

RECRUITING

Kymera Investigative Site

Gyeonggi-do, South Korea

RECRUITING

Kymera Investigative Site

Incheon, South Korea

RECRUITING

Kymera Investigative Site

Seoul, South Korea

RECRUITING

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

Central Study Contacts

Kymera Medical Director

CONTACT

857-285-5300; clinicaltrials@kymeratx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2025
• First Posted: October 15, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5); CA (9); US (20); CZ (2); AU (5); DE (6); PL (9); KR (5)