Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-02-24 @ 2:30 PM
Study NCT ID:
NCT01908595
Status:
COMPLETED
Last Update Posted:
2015-09-02
First Post:
2013-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Study to Evaluate Safety and Efficacy 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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 480}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'dispFirstSubmitDate': '2015-08-14', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-14', 'studyFirstSubmitDate': '2013-07-23', 'dispFirstSubmitQcDate': '2015-08-14', 'studyFirstSubmitQcDate': '2013-07-23', 'dispFirstPostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time course change of Investigator Global Assessment', 'timeFrame': '4 weeks interval'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the efficacy and safety for long term use 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 treatment.\n* Who have been treated with systemic therapy within 30days of treatment.\n* Who have treated with biologics within 5 half-lives of the biologics before the day of treatment\n* Who have been treated with topical therapy within 14days before the day of treatment.'}, 'identificationModule': {'nctId': 'NCT01908595', 'briefTitle': 'Long Term Study to Evaluate Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Maruho North America Inc.'}, 'officialTitle': 'An Open-label, Multi-center, Long-term Study to Evaluate the Safety and Efficacy of M518101 in Subjects With Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'M518101-US04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'M518101', 'description': 'Proper quantity twice daily', 'interventionNames': ['Drug: M518101']}], 'interventions': [{'name': 'M518101', 'type': 'DRUG', 'armGroupLabels': ['M518101']}]}, 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'80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Horizons Clinical Research Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Dermatology and Aesthetic Center Skin Care', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33027', 'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'FXM Research Miramar', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Renstar Medical Research', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 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'lon': -93.26328}}, {'zip': '89074', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'J Woodson Dermatology and Associates', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27518', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG research of raleigh', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PMG Research of Wilmington', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '45249', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97035', 'city': 'Lake Oswego', 'state': 'Oregon', 'country': 'United States', 'facility': 'Bager Allergy, Asthma and Dermatology Research Center', 'geoPoint': {'lat': 45.42067, 'lon': -122.67065}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'PMG Research of Bristol', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '37917', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Dermatology Associates of Knoxville', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '37922', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The skin wellness center', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '77056', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Suzanne Bruce & Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Across America', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Progressive Clinical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78249', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Stephen Miller', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84117', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Dermatology Research Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53719', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Madison Skin & Research', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maruho North America Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}