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Oral KT-621 for moderate-to-severe atopic dermatitis

A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study With an Open-label Period Investigating the Efficacy and Safety Profile of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis

Phase 2 Interventional Kymera Therapeutics, Inc. · NCT07217015

This study will try an oral drug called KT-621 to reduce skin inflammation and itch in teens and adults with moderate-to-severe atopic dermatitis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment200 (estimated)
Ages12 Years to 75 Years
SexAll
SponsorKymera Therapeutics, Inc. Industry-sponsored
Drugs / interventionsdupilumab, tralokinumab, upadacitinib, abrocitinib
Locations61 sites (Birmingham, Alabama and 60 other locations)
Trial IDNCT07217015 on ClinicalTrials.gov

What this trial studies

KT-621 is an oral targeted protein degrader aimed at STAT6 signaling and is being tested as a new systemic option for atopic dermatitis. This phase 2b trial randomizes adolescents and adults to KT-621 or placebo in a 16-week double-blind period followed by a 52-week open-label extension. Key outcomes include change in disease extent and severity (EASI, vIGA-AD, BSA), patient-reported itch, safety and tolerability, and drug behavior in the body (PK/PD). Participants must meet defined severity thresholds and have a history of inadequate response or inability to use topical therapies.

Who should consider this trial

Good fit: Ideal candidates are 12–75 years old with chronic moderate-to-severe atopic dermatitis (EASI ≥16, vIGA-AD ≥3, ≥10% BSA, weekly peak itch ≥4) and a recent history of inadequate response or inability to use topical treatments.

Not a fit: Patients with mild atopic dermatitis, those younger than 12, or those who are well-controlled on topical therapy are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, KT-621 could provide an effective oral treatment that reduces inflammation and itch for people with moderate-to-severe atopic dermatitis.

How similar studies have performed: Targeted STAT6 protein degraders are a novel approach with limited prior clinical data, though other systemic therapies for atopic dermatitis have demonstrated efficacy.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Birmingham, Alabama and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atopic DermatitisSTAT6stat6 degradertargeted protein degraderPhase 2Phase 2bkt-621
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.