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KT-621

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |Kymera Therapeutics, Inc.|Last Updated: Jun 30, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment222
FDA Designations
FAST_TRACK
Clinical trial landscape

KT-621 · 5 trials · 4 indications

Phase 2 3Phase 1 2
NCT07677059A Long-term Study of KT-621 Administered Orally to Participants With Asthma Previously Enrolled in a KT-621 Asthma StudyAsthma (Diagnosis)
RECRUITING264 Analytics
NCT07323654A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic AsthmaEosinophilic Asthma
RECRUITING264 Analytics
NCT07217015A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic DermatitisAtopic Dermatitis
ACTIVE NOT_RECRUITING200 Analytics
PHASE2RECRUITING
A Long-term Study of KT-621 Administered Orally to Participants With Asthma Previously Enrolled in a KT-621 Asthma Study
Asthma (Diagnosis)
NCT07677059264
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PHASE2RECRUITING
A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma
Eosinophilic Asthma
NCT07323654264
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PHASE2ACTIVE NOT_RECRUITING
A Study of KT-621 Administered Orally to Participants With Moderate to Severe Atopic Dermatitis
Atopic Dermatitis
NCT07217015200
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Study Endpoints
Primary Endpoints
Incidence of treatment-emergent adverse events (TEAEs)
From baseline through Week 52
Incidence of treatment-emergent serious adverse events (SAEs)
From baseline through Week 52
Change from baseline in pre-bronchodilator FEV1
From baseline to Week 12
Change from baseline in Eczema Area and Severity Index (EASI) score
From baseline through Week 16
Incidence of adverse events (AEs)
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.
From enrollment through the safety follow-up visit on Day 43
Incidence of adverse events
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically-significant abnormalities in safety laboratory parameters: hematology
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

Hemoglobin, Hematocrit, Erythrocytes, Mean corpuscular volume, Platelets, Leukocytes, Eosinophils, Basophils Neutrophils Lymphocytes Monocytes

Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: serum chemistry
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

Glucose, Blood urea nitrogen, Creatinine, Sodium, Potassium, Calcium, Chloride, Magnesium, Bicarbonate, Phosphate, Bilirubin, total and direct, Alkaline phosphatase, Aspartate transaminase (=SGOT), Alanine transaminase (=SGPT), Gamma glutamyl transferase, Total protein, Albumin, Creatine kinase, HbA1c, Lactate dehydrogenase (LDH)

Treatment-emergent potentially clinically significant abnormalities in safety laboratory parameters: coagulation
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)

Activated partial thromboplastin time, Prothrombin time, International Normalized Ratio, Fibrinogen

Treatment-emergent potentially clinically significant abnormalities in electrocardiogram values: QTcF (milliseconds)
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: heart rate (beats per minute)
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: blood pressure (mmHg)
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: respiratory rate (breaths per minute)
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Treatment-emergent potentially clinically significant abnormalities in vital signs: temperature (degrees Celsius)
From enrollment through the safety follow-up visit on either Day 14 (SAD) or Day 38 (MAD)
Secondary Endpoints
Change from baseline in pre-bronchodilator FEV1
From baseline (as assessed in the parent study) to Week 52
Change from baseline in post-bronchodilator FEV1
From baseline (as assessed in the parent study) to Week 52
Change from baseline in Asthma Control Questionnaire 5-question version (ACQ-5) score
From baseline (as assessed in the parent study) to Week 52
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
KT-621EXPERIMENTAL -
Group 1: KT-621 Dose 1EXPERIMENTAL -
Group 2: KT-621 Dose 2EXPERIMENTAL -
Group 3: KT-621 Dose 3EXPERIMENTAL -
Group 4: PlaceboPLACEBO_COMPARATOR -
PlaceboPLACEBO_COMPARATOREach participant receives either a single oral dose (SAD) or multiple oral doses (MAD) of matched placebo.
Interventions
NameTypeDescription
KT-621DRUGOral drug
PlaceboOTHEROral placebo matched to KT-621
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Must have completed all visits of the parent study, per its protocol, up to the end of treatment (EoT) visit. * Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, other study-related procedures, and questionnaires, including completing ...

Countries:United StatesGermanyPolandRomaniaSerbiaSlovakiaSpainUnited KingdomAustraliaCanadaCzechiaJapanSouth Korea
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Competitive Landscape -Atopic Dermatitis 80 trials

Top 20 of 26 competitors

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY6PHASE3Baricitinib, corticosteroid
AbbVie, Inc.ABBV10PHASE3Upadacitinib, corticosteroids
Pfizer Inc.PFE12PHASE3Abrocitinib
Sanofi SA Sponsored ADRSNY13PHASE3Amlitelimab
Regeneron Pharmaceuticals, Inc.REGN4PHASE3Dupilumab
Incyte CorporationINCY3PHASE3Ruxolitinib, Vehicle
Organon & Co.OGN1PHASE3Tapinarof , 1%, Vehicle
Apogee Therapeutics, Inc.APGE3PHASE2APG777
Novartis AG Sponsored ADRNVS2PHASE2GIA632
Kymera Therapeutics, Inc.KYMR1PHASE2KT-621
Corvus Pharmaceuticals, Inc.CRVS1PHASE2Soquelitinib
Johnson & JohnsonJNJ1PHASE2JNJ-95597528
Nektar TherapeuticsNKTR1PHASE2Rezpegaldesleukin
Celldex Therapeutics, Inc.CLDX1PHASE2Barzolvolimab
Evommune, Inc.EVMN1PHASE2EVO756
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
Q32 Bio IncQTTB1PHASE2ADX-914
Turn Therapeutics Inc.TTRX1PHASE2GX-03
Sunshine Biopharma IncorporatedSBFM2PHASE3611, corticosteroid
Co-Diagnostics, Inc.CODX1PHASE3611
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Recent Changes (Last 90 Days)
LOWJun 30, 2026NCT07677059NEW_TRIAL: changed
MEDIUMJun 30, 2026NCT07217015Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 30, 2026NCT07677059NEW_TRIAL: changed
MEDIUMJun 30, 2026NCT07217015Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 30, 2026NCT07677059NEW_TRIAL: changed
MEDIUMJun 30, 2026NCT07217015Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWJun 29, 2026NCT07323654lastUpdatePostDate: changed
LOWJun 29, 2026NCT07323654lastUpdatePostDate: changed
LOWMay 26, 2026NCT07217015primaryCompletionDate: changed
LOWMay 26, 2026NCT07323654primaryCompletionDate: changed
LOWMay 24, 2026NCT07217015studyFirstPostDate: changed
LOWMay 24, 2026NCT07323654studyFirstPostDate: changed