Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-04-15 @ 2:58 PM
Study NCT ID:
NCT01878461
Status:
COMPLETED
Last Update Posted:
2015-09-02
First Post:
2013-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 542}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'dispFirstSubmitDate': '2015-08-14', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-14', 'studyFirstSubmitDate': '2013-06-06', 'dispFirstSubmitQcDate': '2015-08-14', 'studyFirstSubmitQcDate': '2013-06-12', 'dispFirstPostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator Global Assessment', 'timeFrame': '8 weeks after dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the efficacy and safety of M518101 in subjects with plaque psoriasis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Who are able and willing to give signed informed consent\n* Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.\n* Who have up to 20% of body surface area (BSA) afflicted with plaques\n* Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.\n\nExclusion Criteria:\n\n* Who have a history of allergy to vitamin D3 derivative preparations or a history of relevant drug hypersensitivity.\n* Who are pregnant or lactating.\n* Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.\n* Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.\n* Who have clinically relevant history or presence of any disease or surgical history other than psoriasis which is likely to affect the conduct of the study\n* Whose serum calcium levels exceed the upper limit of reference range\n* Who have used any investigational medicinal product and/or participated in any clinical study within 60 days of randomization.\n* Who have been treated with systemic therapy within 30days of randomization.\n* Who have treated with biologics within 5 half-lives of the biologics before the day of randomization\n* Who have been treated with topical therapy within 14days before the day of randomization.'}, 'identificationModule': {'nctId': 'NCT01878461', 'briefTitle': 'Evaluate the Efficacy and Safety of M518101 in Subjects With Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Maruho North America Inc.'}, 'officialTitle': 'A Randomized, Vehicle Controlled, Double Blind, Parallel Group, Multi Center PhaseIII Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'M518101-US03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Proper quantity twice a day', 'interventionNames': ['Drug: Vehicle']}, {'type': 'EXPERIMENTAL', 'label': 'M518101', 'description': 'Proper quantity twice a day', 'interventionNames': ['Drug: M518101']}], 'interventions': [{'name': 'Vehicle', 'type': 'DRUG', 'armGroupLabels': ['Vehicle']}, {'name': 'M518101', 'type': 'DRUG', 'armGroupLabels': ['M518101']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85202', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Agave Clinical Research', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'T Joseph Raoof', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92108', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Medical Center for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Therapeutics Clinical Research', 'geoPoint': 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