Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-25 @ 4:02 PM
Study NCT ID:
NCT04119557
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2019-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of LY3471851 in Participants With Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue 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': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2019-10-07', 'studyFirstSubmitQcDate': '2019-10-07', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-21', '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': ['Psoriasis']}, '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/1ECCCFhgylJrD8j0XVPGI6', 'label': 'A Study of LY3471851 in Participants With Psoriasis'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to learn more about the safety of LY3471851 when given by injection just under the skin to participants with psoriasis. 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 psoriasis for at least 6 months\n* Have active psoriasis plaques 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 psoriasis within 14 days prior to baseline\n* Have received certain systemic medications for psoriasis within 4 weeks prior to baseline\n* Have received LY3471851 previously'}, 'identificationModule': {'nctId': 'NCT04119557', 'briefTitle': 'A Study of LY3471851 in Participants With Psoriasis', '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 Psoriasis', 'orgStudyIdInfo': {'id': '17239'}, 'secondaryIdInfos': [{'id': 'J1P-MC-KFAC', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo administered subcutaneously (SC) every 2 weeks for a period of 12 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1 - 10 (Microgram Per Kilogram) μg/kg LY3471851', 'description': 'Participants received 10 μg/kg of LY3471851 SC every 2 weeks for a period of 12 weeks.', 'interventionNames': ['Drug: LY3471851']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 - 24 μg/kg LY3471851', 'description': 'Participants received 24 μg/kg of LY3471851 SC every 2 weeks for a period of 12 weeks.', 'interventionNames': ['Drug: LY3471851']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}, {'name': 'LY3471851', 'type': 'DRUG', 'otherNames': ['NKTR-358'], 'description': 'Administered SC', 'armGroupLabels': ['Cohort 1 - 10 (Microgram Per Kilogram) μg/kg LY3471851', 'Cohort 2 - 24 μg/kg LY3471851']}]}, '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': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Academic Centers Research and Education, LLC', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'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': '40241', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Forefront Research', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '48047', 'city': 'Chesterfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Clinical Research Institute of Michigan, LLC', 'geoPoint': {'lat': 42.66281, 'lon': -82.84242}}, {'zip': '48084', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Derm Center', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '63117', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Central Dermatology PC', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'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': '78229', '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'}}}}