Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT06945458
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2025-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, PK, PD, and Clinical Activity of Orally Administered KT-621 in Adult Patients With Atopic Dermatitis (AD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-04-09', 'studyFirstSubmitQcDate': '2025-04-17', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'KT-621 concentrations in skin', 'timeFrame': 'From baseline visit through the safety follow-up visit on Day 43'}, {'measure': 'Change in Eczema Area and Severity Index (EASI) score', 'timeFrame': 'From screening through the safety follow-up visit on Day 43'}, {'measure': 'Proportion of participants who achieve a validated Investigator Global Assessment (vIGA) score of 0 or 1 at scheduled clinic visits', 'timeFrame': 'From screening through the safety follow-up visit on Day 43', 'description': 'On a scale of 0 to 4, 0 being no inflammatory signs of AD, 4 being severe inflammatory signs of AD'}, {'measure': 'Change from baseline in the Peak Pruritus Numeric Rating Scale (NRS) score', 'timeFrame': 'From baseline visit through the safety follow-up visit on Day 43', 'description': 'Percent change from baseline'}, {'measure': 'Change from baseline in levels of signal transducer and activator of transcription 6 protein, in skin and in whole blood', 'timeFrame': 'From baseline visit through the safety follow-up visit on Day 43'}, {'measure': 'Change from baseline in the serum levels of Th2 biomarkers such as thymus and activation-regulated chemokine (TARC)', 'timeFrame': 'From baseline visit through the safety follow-up visit on Day 43'}, {'measure': 'Change from baseline through Week 4 in the serum levels of proinflammatory cytokines', 'timeFrame': 'From baseline visit through the safety follow-up visit on Day 43'}, {'measure': 'Change from baseline through Week 4 in messenger RNA transcriptome levels on the skin.', 'timeFrame': 'From baseline visit through the safety follow-up visit on Day 43'}], 'primaryOutcomes': [{'measure': 'Incidence of adverse events (AEs)', 'timeFrame': 'From enrollment through the safety follow-up visit on Day 43'}, {'measure': '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.', 'timeFrame': 'From enrollment through the safety follow-up visit on Day 43'}], 'secondaryOutcomes': [{'measure': 'Plasma PK parameter estimates of KT-621 derived from plasma concentration-time data', 'timeFrame': 'From baseline visit through the safety follow-up visit on Day 43', 'description': 'Trough concentrations taken at each visit before dosing, post-dose concentrations taken after dosing at Days 1 and 15.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['KT621', 'STAT6', 'STAT6 degrader', 'Targeted protein degrader', 'Phase 1'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants aged 18 to 55 years (inclusive) at the time of screening\n* Participants must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures\n* Participants must have had chronic atopic dermatitis (AD) for at least 1 year before Screening.\n* Moderate to very severe eczema as determined by Eczema Area and Severity Index (EASI) score of at least 16 at the baseline visit.\n* A validated Investigator Global Assessment (vIGA) score of at least 3 at the baseline visit, indicating moderate to severe AD.\n* At least 10% body surface area (BSA) of AD involvement at the baseline visit.\n* Weekly average Peak Pruritus Numeric Rating Scale (NRS) of at least 4 at the baseline visit.\n* Documented history within 6 months prior to baseline visit of either inadequate response or contraindication to topical medications for AD.\n* Application of stable dose of moisturizer at least twice daily for at least 7 consecutive days immediately prior to the baseline visit.\n\nExclusion Criteria:\n\n* 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.\n* Participants who have any surgical or medical procedure planned during participation in the study.\n* Participants with a history of alcohol or substance abuse within the previous 2 years.\n* Participants who have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results.\n* Participants whose results from clinical laboratory safety tests are outside the local reference range at Screening.\n* 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.\n* 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.\n* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.\n* Female participants of childbearing potential with a positive or undetermined pregnancy result at the Screening and baseline visits.\n* Participants with a known sensitivity to any of the components of KT-621.\n* Participants who are a member of the investigational team or his/her immediate family.'}, 'identificationModule': {'nctId': 'NCT06945458', 'acronym': 'BroADen', 'briefTitle': 'Safety, PK, PD, and Clinical Activity of Orally Administered KT-621 in Adult Patients With Atopic Dermatitis (AD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kymera Therapeutics, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'KT621-AD-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KT-621', 'description': 'Each participant receives daily oral doses of KT-621 throughout the 28-day treatment period.', 'interventionNames': ['Drug: KT-621']}], 'interventions': [{'name': 'KT-621', 'type': 'DRUG', 'description': 'Oral drug', 'armGroupLabels': ['KT-621']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35244', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Kymera Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Kymera Investigative Site', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Kymera Investigative Site', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33436', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Kymera Investigative Site', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Kymera Investigative Site', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Kymera Investigative Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '58078', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Kymera Investigative Site', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '43016', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'Kymera Investigative Site', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '45505', 'city': 'Springfield', 'state': 'Ohio', 'country': 'United States', 'facility': 'Kymera Investigative Site', 'geoPoint': {'lat': 39.92423, 'lon': -83.80882}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Kymera Investigative Site', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '29420', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Kymera Investigative Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '78213', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Kymera Investigative Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kymera Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}