Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-02-10 @ 11:11 PM
Study NCT ID:
NCT02896868
Status:
COMPLETED
Last Update Posted:
2019-05-03
First Post:
2016-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3041658 in Participants With Skin Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05-01', 'completionDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-02', 'studyFirstSubmitDate': '2016-09-07', 'studyFirstSubmitQcDate': '2016-09-07', 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-19', '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': 'Dosing Day 1 through Day 127'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3041658', 'timeFrame': 'Dosing Day 1 through Day 127'}, {'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) During Dosing Interval at Steady State (AUCss) of LY3041658', 'timeFrame': 'Dosing Day 1 through Day 127'}, {'measure': 'Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3041658', 'timeFrame': 'Dosing Day 1 through Day 127'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Skin Diseases', 'Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.lillytrialguide.com/en-US/studies/skin-disease/DSAB#?postal=', 'label': 'Click here for more information about this study: A Study of LY3041658 in Participants With Skin Diseases'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to investigate the safety and tolerability of the study drug known as LY3041658 in participants with certain types of skin diseases. The study will measure how the body absorbs, breaks down and gets rid of LY3041658. It will last about 127 days for each participant, not including screening. This study is for research purposes only, and is not intended to treat any medical condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Investigator confirmed diagnosis of certain skin diseases for at least 6 months.\n* Active skin lesions that are not responding to standard therapies.\n* Willing to undergo pre- and post-treatment skin biopsies of lesions.\n\nExclusion Criteria:\n\n\\- Have other skin diseases that may interfere with evaluation of the specified skin disease being studied.'}, 'identificationModule': {'nctId': 'NCT02896868', 'briefTitle': 'A Study of LY3041658 in Participants With Skin Diseases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3041658 in Patients With Skin Diseases', 'orgStudyIdInfo': {'id': '15165'}, 'secondaryIdInfos': [{'id': 'I7P-MC-DSAB', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3041658', 'description': 'LY3041658 administered intravenously (IV) once every two weeks over 6 weeks (four doses).', 'interventionNames': ['Drug: LY3041658']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered IV once every two weeks over 6 weeks (four doses).', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY3041658', 'type': 'DRUG', 'description': 'Administered IV.', 'armGroupLabels': ['LY3041658']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered IV.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206-4140', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Parexel Early Phase Unit at Glendale', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretzin Clinical Research', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21225', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'PAREXEL-Phase 1 Baltimore Harbor Hospital Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}