Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2025-12-29 @ 10:35 AM
Study NCT ID:
NCT04975295
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2021-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of LY3361237 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': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-01', 'studyFirstSubmitDate': '2021-07-22', 'studyFirstSubmitQcDate': '2021-07-22', 'lastUpdatePostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration', 'timeFrame': 'Baseline through Day 253', 'description': 'A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of LY3361237 During the Dosing Interval', 'timeFrame': 'Day 1 predose through Day 253', 'description': 'PK: Cmin of LY3361237 During the Dosing Interval'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/5M4E6fdkjelSDEBizWd8Bg', 'label': 'A Study of LY3361237 in Participants With Psoriasis'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to learn more about the safety and tolerability of LY3361237 and any side effects that might be associated with it when given to participants with psoriasis. LY3361237 will be administered by injections just under the skin. The study will last up to 41 weeks and may include up to 15 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 chronic plaque psoriasis for at least 6 months\n* Be willing and able to undergo skin biopsies\n* Body mass index (BMI) within the range of 18 to 40 kilograms per meter squared (kg/m²)\n* Female participants must agree to use birth control during the study\n\nExclusion Criteria:\n\n* Have had certain types of infection within the last six months\n* Have a clinically significant active infection, or recent acute active infection within the last 30 days\n* Have other serious or unstable illnesses\n* Have a history of organ or bone marrow transplant\n* Have received any live vaccine within the last 4 weeks prior to screening\n* Have received systemic nonbiologic psoriasis therapy within 4 weeks prior to study day 1\n* Have received topical psoriasis treatment within 14 days prior to study day 1\n* Have excessive skin exposure or use tanning booths for at least 4 weeks prior to study day 1'}, 'identificationModule': {'nctId': 'NCT04975295', 'briefTitle': 'A Study of LY3361237 in Participants With Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Participants With Psoriasis', 'orgStudyIdInfo': {'id': '17291'}, 'secondaryIdInfos': [{'id': 'I9S-MC-BTAC', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2019-003187-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3361237', 'description': 'LY3361237 administered subcutaneously (SC).', 'interventionNames': ['Drug: LY3361237']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered SC.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY3361237', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['LY3361237']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1606', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'MC Comac Medical', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1027', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Budai Irgalmasrendi Korhaz', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '94048', 'city': 'Lodz', 'country': 'Poland', 'facility': 'All Med - Lodz', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '61-113', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Ai Centrum Medyczne Sp. Z O.O. Sp.K.', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '00-728', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'WIP Warsaw IBD Point Profesor Kierkus', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '01-868', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Pratia - Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '831', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Summit Clinical Research, s.r.o. - Bratislava', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}], '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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}