Evaluating the safety and effectiveness of KT-621 for treating atopic dermatitis

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

This study is testing a new oral medication called KT-621 to see if it can safely help adults with moderate to severe atopic dermatitis feel better.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Kymera Therapeutics, Inc. (industry)
• Drugs / interventions: dupilumab, tralokinumab, upadacitinib, abrocitinib
• Locations: 12 sites (Birmingham, Alabama and 11 other locations)
• Trial ID: NCT06945458 on ClinicalTrials.gov

What this trial studies

This study assesses the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of KT-621, an orally administered medication, in adult patients suffering from moderate to severe atopic dermatitis. Participants will be monitored for their response to the treatment over a specified period, with evaluations based on established clinical scales. The study aims to gather data on how well KT-621 works and its potential side effects in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 55 with chronic moderate to severe atopic dermatitis who have not responded adequately to topical treatments.

Not a fit: Patients with mild atopic dermatitis or those who have not had chronic eczema for at least one year may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new oral option for patients with moderate to severe atopic dermatitis, improving their quality of life.

How similar studies have performed: Other studies involving targeted protein degraders have shown promise, but this specific approach with KT-621 is novel.

Eligibility criteria

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.

Where this trial is running

Birmingham, Alabama and 11 other locations

• Kymera Investigative Site — Birmingham, Alabama, United States (RECRUITING)
• Kymera Investigative Site — Fountain Valley, California, United States (NOT_YET_RECRUITING)
• Kymera Investigative Site — Santa Monica, California, United States (RECRUITING)
• Kymera Investigative Site — Boynton Beach, Florida, United States (RECRUITING)
• Kymera Investigative Site — Hollywood, Florida, United States (RECRUITING)
• Kymera Investigative Site — Tampa, Florida, United States (RECRUITING)
• Kymera Investigative Site — Fargo, North Dakota, United States (RECRUITING)
• Kymera Investigative Site — Dublin, Ohio, United States (RECRUITING)
• Kymera Investigative Site — Springfield, Ohio, United States (NOT_YET_RECRUITING)
• Kymera Investigative Site — Tulsa, Oklahoma, United States (RECRUITING)
• Kymera Investigative Site — Charleston, South Carolina, United States (RECRUITING)
• Kymera Investigative Site — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Kymera Medical Director

Conditions: Atopic Dermatitis, KT621, STAT6, STAT6 degrader, Targeted protein degrader, Phase 1