Atopic DermatitisPhase 2BROADEN2NCT07217015
A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis
A Phase 2 study testing KT-621 in people with Atopic Dermatitis, run by Kymera Therapeutics, Inc. at 61 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 75 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?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 61 sitesin 8 countries
- Study dates
- 24 Nov 2025to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
61 sites in 8 countries.
61 sites in 8 countries
United States19 sites
Kymera Investigative Site
Ann Arbor, Michigan, 48103
Kymera Investigative Site
Birmingham, Alabama, 35244
Kymera Investigative Site
Delray Beach, Florida, 33484
Kymera Investigative Site
Detroit, Michigan, 48202
Kymera Investigative Site
Fargo, North Dakota, 58103
Kymera Investigative Site
Jacksonville, Florida, 32256
Kymera Investigative Site
Los Angeles, California, 90025
Kymera Investigative Site
Los Angeles, California, 90045
Kymera Investigative Site
Miami, Florida, 33137
Kymera Investigative Site
Miami, Florida, 33162
Kymera Investigative Site
Miramar, Florida, 33027
Kymera Investigative Site
Normal, Illinois, 61761
Kymera Investigative Site
North Little Rock, Arkansas, 72117
Kymera Investigative Site
Philadelphia, Pennsylvania, 19103
Kymera Investigative Site
Portland, Oregon, 97201
Kymera Investigative Site
Portland, Oregon, 97239
Kymera Investigative Site
San Antonio, Texas, 78213
Kymera Investigative Site
San Antonio, Texas, 78218
Kymera Investigative Site
The Bronx, New York, 10455
Canada9 sites
Kymera Investigative Site
Calgary, Alberta
Kymera Investigative Site
Edmonton, Alberta
Kymera Investigative Site
Kelowna, British Columbia
Kymera Investigative Site
Markham, Ontario
Kymera Investigative Site
Ottawa, Ontario
Kymera Investigative Site
Québec, Quebec
Kymera Investigative Site
Richmond Hill, Ontario
Kymera Investigative Site
Surrey, British Columbia
Kymera Investigative Site
Toronto, Ontario
Poland9 sites
Kymera Investigative Site
Chorzów
Kymera Investigative Site
Gdansk
Kymera Investigative Site
Gdynia
Kymera Investigative Site
Krakow
Kymera Investigative Site
Lublin
Kymera Investigative Site
Rzeszów
Kymera Investigative Site
Szczecin
Kymera Investigative Site
Warsaw
Kymera Investigative Site
Wroclaw
Japan7 sites
Kymera Investigative Site
Ichikawa, Chiba
Kymera Investigative Site
Kagoshima
Kymera Investigative Site
Kanagawa
Kymera Investigative Site
Nagoya
Kymera Investigative Site
Osaka
Kymera Investigative Site
Sakai
Kymera Investigative Site
Sapporo
Australia5 sites
Kymera Investigative Site
Brisbane, Queensland
Kymera Investigative Site
Darlinghurst, New South Wales
Kymera Investigative Site
Kogarah, New South Wales
Kymera Investigative Site
Melbourne, Victoria
Kymera Investigative Site
Woolloongabba, Queensland
Germany5 sites
Kymera Investigative Site
Bad Bentheim
Kymera Investigative Site
Frankfurt
Kymera Investigative Site
Mainz
Kymera Investigative Site
München, Bavaria
Kymera Investigative Site
Münster
South Korea5 sites
Kymera Investigative Site
Ansan-si
Kymera Investigative Site
Cheonan
Kymera Investigative Site
Gyeonggi-do
Kymera Investigative Site
Incheon
Kymera Investigative Site
Seoul
Czechia2 sites
Kymera Investigative Site
Pardubice
Kymera Investigative Site
Prague
About this study
Official title: 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
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
- Being tested
- KT-621, Placebo
- Keywords
- STAT6, stat6 degrader, targeted protein degrader, Phase 2, Phase 2b, kt-621
- 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
PlaceboOther
Oral placebo matched to KT-621
| Study group | Role | What they receive |
|---|---|---|
| Group 1: KT-621 Dose 1 | Experimental | Not described Receives: Drug: KT-621 |
| Group 2: KT-621 Dose 2 | Experimental | Not described Receives: Drug: KT-621 |
| Group 3: KT-621 Dose 3 | Experimental | Not described Receives: Drug: KT-621 |
| Group 4: Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Eczema Area and Severity Index (EASI) score
Measured: From baseline through Week 16
Secondary outcomes (12)
Incidence of treatment-emergent adverse events (TEAEs)
Measured: From baseline through Week 16, and from Week 16 through Week 68
Incidence of treatment-emergent serious adverse events (SAEs)
Measured: From baseline through Week 16, and from Week 16 through Week 68
Percentage change from baseline in body surface area (BSA) affected by AD
Measured: From baseline to Week 16 and to Week 68
Percentage change from baseline in the Peak Pruritus NRS score
Measured: 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)
Measured: At Week 16 and at Week 68
Proportion of participants who achieve a validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 0 to 1 (on a 5-point scale) and a reduction from the baseline value of at least 2 points
Measured: At Week 16 and at Week 68
Proportion of participants with EASI-50, EASI-75, and EASI-90
Measured: At Week 16 and at Week 68
Percentage change from baseline in the EASI score
Measured: From baseline to Week 68
Percentage change from baseline in the SCORing Atopic Dermatitis (SCORAD) score
Measured: From baseline to Week 16, and to Week 68
Change from baseline in the Patient-Oriented Eczema Measure (POEM)
Measured: From baseline to Week 16, and to Week 68
Change from baseline in the Dermatology Life Quality Index (DLQI)
Measured: From baseline to Week 16, and to Week 68
Plasma concentration of KT-621 derived from plasma concentration time data
Measured: From baseline to Week 16, and to Week 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start24 Nov 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kymera Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217015
- Sponsor's protocol ID
- KT621-AD-201
- Other IDs
- 2025-522370-36-00, 2025
- Acronym
- BROADEN2
- Status last verified
- Jan 2026
- First submitted
- 13 Oct 2025
- Last updated
- 6 Oct 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07217015
- Acronym / sponsor ID
- BROADEN2 / KT621-AD-201
- Conditions
- Atopic Dermatitis
- Keywords
- STAT6, stat6 degrader, targeted protein degrader, Phase 2, Phase 2b, kt-621
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kymera Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Oct 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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 | Group 1: KT-621 Dose 1, Group 2: KT-621 Dose 2, Group 3: KT-621 Dose 3 |
| PlaceboOral placebo matched to KT-621 | Other | Group 4: Placebo |
Primary outcome
Change from baseline in Eczema Area and Severity Index (EASI) score
Time frame: From baseline through Week 16
12 secondary outcomes
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From baseline through Week 16, and from Week 16 through Week 68
Incidence of treatment-emergent serious adverse events (SAEs)
Time frame: From baseline through Week 16, and from Week 16 through Week 68
Percentage change from baseline in body surface area (BSA) affected by AD
Time frame: From baseline to Week 16 and to Week 68
Percentage change from baseline in the Peak Pruritus NRS score
Time frame: 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)
Time frame: At Week 16 and at Week 68
Proportion of participants who achieve a validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 0 to 1 (on a 5-point scale) and a reduction from the baseline value of at least 2 points
Time frame: At Week 16 and at Week 68
Proportion of participants with EASI-50, EASI-75, and EASI-90
Time frame: At Week 16 and at Week 68
Percentage change from baseline in the EASI score
Time frame: From baseline to Week 68
Percentage change from baseline in the SCORing Atopic Dermatitis (SCORAD) score
Time frame: From baseline to Week 16, and to Week 68
Change from baseline in the Patient-Oriented Eczema Measure (POEM)
Time frame: From baseline to Week 16, and to Week 68
Change from baseline in the Dermatology Life Quality Index (DLQI)
Time frame: From baseline to Week 16, and to Week 68
Plasma concentration of KT-621 derived from plasma concentration time data
Time frame: From baseline to Week 16, and to Week 68
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 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.
61 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KT-621 in people with Atopic Dermatitis, run by Kymera Therapeutics, Inc. at 61 sites in 8 countries.
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 10 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Canada, Poland, Japan, Australia and 3 more countries. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline in Eczema Area and Severity Index (EASI) score (time frame: From baseline through Week 16). 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 6 Oct 2026.