Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT04081350
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2019-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3471851 in Participants With Eczema
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02-15', 'completionDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2019-09-05', 'studyFirstSubmitQcDate': '2019-09-05', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Baseline through Study Completion (up to Week 48)', 'description': 'A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851', 'timeFrame': 'Postdose on Day 1 through Day 14', 'description': 'PK: AUC of LY3471851'}, {'measure': 'PK: Trough Concentrations (Ctrough) of LY3471851', 'timeFrame': 'Week 12', 'description': 'PK: Ctrough of LY3471851'}, {'measure': 'PK: Maximum Concentration (Cmax) of LY3471851', 'timeFrame': 'Postdose on Day 1 through Day 14', 'description': 'PK: Cmax of LY3471851'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dermatitis, Atopic']}, 'referencesModule': {'references': [{'pmid': '39455575', 'type': 'DERIVED', 'citation': 'Silverberg JI, Rosmarin D, Chovatiya R, Bieber T, Schleicher S, Beck L, Gooderham M, Chaudhry S, Fanton C, Yu D, Levy J, Liu Y, Miyazaki T, Tagliaferri M, Schmitz C, Nirula A, Kotzin B, Zalevsky J. The regulatory T cell-selective interleukin-2 receptor agonist rezpegaldesleukin in the treatment of inflammatory skin diseases: two randomized, double-blind, placebo-controlled phase 1b trials. Nat Commun. 2024 Oct 25;15(1):9230. doi: 10.1038/s41467-024-53384-1.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/3Ex7XDC7Soi22zSKKaGtrA', 'label': 'A Study of LY3471851 in Participants With Eczema'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to learn more about the safety and side effects of LY3471851 when given by injection just under the skin to participants with eczema. The study will last up to 48 weeks and may include up to 23 visits to the study center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a confirmed diagnosis of atopic dermatitis (AD) for least 12 months\n* Have active AD according to study specific criteria\n* Be willing and able to undergo skin biopsies\n\nExclusion Criteria:\n\n* Have received certain topical medications for AD within 14 days prior to baseline\n* Have received certain systemic medications for AD within 4 weeks prior to baseline\n* Have received LY3471851 previously'}, 'identificationModule': {'nctId': 'NCT04081350', 'briefTitle': 'A Study of LY3471851 in Participants With Eczema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nektar Therapeutics'}, 'officialTitle': 'A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Patients With Atopic Dermatitis', 'orgStudyIdInfo': {'id': '17240'}, 'secondaryIdInfos': [{'id': 'J1P-MC-KFAD', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '10 µg/kg LY3471851', 'description': 'Participants received subcutaneous (SC) injection of 10 microgram per kilogram (μg/kg) LY3471851 every 2 weeks for a treatment period of 12 weeks.', 'interventionNames': ['Drug: LY3471851']}, {'type': 'ACTIVE_COMPARATOR', 'label': '12 µg/kg LY3471851', 'description': 'Participants received subcutaneous injection of 12 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks.', 'interventionNames': ['Drug: LY3471851']}, {'type': 'ACTIVE_COMPARATOR', 'label': '24 µg/kg LY3471851', 'description': 'Participants received subcutaneous injection of 24 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks.', 'interventionNames': ['Drug: LY3471851']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received subcutaneous injection of placebo every 2 weeks for a treatment period of 12 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY3471851', 'type': 'DRUG', 'otherNames': ['NKTR-358'], 'description': 'Administered SC', 'armGroupLabels': ['10 µg/kg LY3471851', '12 µg/kg LY3471851', '24 µg/kg LY3471851']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72117', 'city': 'North Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Research Trials, LLC', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'California Dermatology & Clinical Research Institute', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '94538', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Center For Dermatology Clinical Research, Inc.', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Therapeutics Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Science Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Dermatology and Laser Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33613-1244', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'ForCare Clinical Research', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30328', 'city': 'Sandy Springs', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical Dermatology Specialists', 'geoPoint': {'lat': 33.92427, 'lon': -84.37854}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretzin Clinical Research Group, LLC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Skin Sciences', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Derm Center', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '03801', 'city': 'Portsmouth', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'ActivMed Practices and Research', 'geoPoint': {'lat': 43.07704, 'lon': -70.75766}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Remington-Davis, Inc', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73118', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Unity Clinical Research', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Paddington Testing Company Inc', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '18249', 'city': 'Sugarloaf', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'DermDox Centers for Dermatology', 'geoPoint': {'lat': 41.98343, 'lon': -76.12083}}, {'zip': '77433', 'city': 'Cypress', 'state': 'Texas', 'country': 'United States', 'facility': 'Studies in Dermatology, LLC', 'geoPoint': {'lat': 29.96911, 'lon': -95.69717}}, {'zip': '75034', 'city': 'Frisco', 'state': 'Texas', 'country': 'United States', 'facility': 'Rodgers Dermatology', 'geoPoint': {'lat': 33.15067, 'lon': -96.82361}}, {'zip': '78213', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Progressive Clinical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77478', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Complete Dermatology', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nektar Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nektar Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}