Atopic DermatitisPhase 1BroADenNCT06945458
Safety, PK, PD, and Clinical Activity of Orally Administered KT-621 in Adult Patients With Atopic Dermatitis (AD)
A Phase 1 study testing KT-621 in people with Atopic Dermatitis, run by Kymera Therapeutics, Inc. at 12 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- KT-621
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 12 sitesUnited States
- Study dates
- 17 Apr 2025to 10 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Kymera Investigative Site
Birmingham, Alabama, 35244
Kymera Investigative Site
Boynton Beach, Florida, 33436
Kymera Investigative Site
Charleston, South Carolina, 29420
Kymera Investigative Site
Dublin, Ohio, 43016
Kymera Investigative Site
Fargo, North Dakota, 58078
Kymera Investigative Site
Fountain Valley, California, 92708
Kymera Investigative Site
Hollywood, Florida, 33024
Kymera Investigative Site
San Antonio, Texas, 78213
Kymera Investigative Site
Santa Monica, California, 90404
Kymera Investigative Site
Springfield, Ohio, 45505
Kymera Investigative Site
Tampa, Florida, 33613
Kymera Investigative Site
Tulsa, Oklahoma, 74136
About this study
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
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
- Being tested
- KT-621
- Keywords
- KT621, STAT6, STAT6 degrader, Targeted protein degrader, Phase 1
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KT-621Drug
Oral drug
| Study group | Role | What they receive |
|---|---|---|
| KT-621 | Experimental | Each participant receives daily oral doses of KT-621 throughout the 28-day treatment period. Receives: Drug: KT-621 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: 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.
Measured: 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
Trough concentrations taken at each visit before dosing, post-dose concentrations taken after dosing at Days 1 and 15.
Measured: From baseline visit through the safety follow-up visit on Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start17 Apr 2025
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kymera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945458
- Sponsor's protocol ID
- KT621-AD-102
- Acronym
- BroADen
- Status last verified
- Jan 2026
- First submitted
- 9 Apr 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06945458
- Acronym / sponsor ID
- BroADen / KT621-AD-102
- Conditions
- Atopic Dermatitis
- Keywords
- KT621, STAT6, STAT6 degrader, Targeted protein degrader, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kymera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KT-621 | Experimental | Drug: KT-621Each participant receives daily oral doses of KT-621 throughout the 28-day treatment period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KT-621Oral drug | Drug | KT-621 |
Primary outcome
Incidence of adverse events (AEs)
Time frame: 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.
Time frame: From enrollment through the safety follow-up visit on Day 43
1 secondary outcome
Plasma PK parameter estimates of KT-621 derived from plasma concentration-time data
Time frame: From baseline visit through the safety follow-up visit on Day 43
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KT-621 in people with Atopic Dermatitis, run by Kymera Therapeutics, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: From enrollment through the safety follow-up visit on Day 43). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.