Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT00884169
Status:
COMPLETED
Last Update Posted:
2010-11-03
First Post:
2009-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2009-12'}, 'lastUpdateSubmitDate': '2010-11-02', 'studyFirstSubmitDate': '2009-04-17', 'studyFirstSubmitQcDate': '2009-04-17', 'lastUpdatePostDateStruct': {'date': '2010-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of plaque psoriasis'}], 'secondaryOutcomes': [{'measure': 'Investigator and Patient overall assessment'}]}, 'conditionsModule': {'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'This study is to investigate the efficacy and safety of M518101 in male and female plaque psoriasis patients with refractory plaques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Who are able and willing to give signed informed consent\n* Who are male or females aged between 18 and 65 years with plaque psoriasis confirmed by the Investigator.\n* Who have less than 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.\n* Who have a history of relevant drug hypersensitivity.\n* Who have a history of contact dermatitis induced by a topical medicine.\n* Who are pregnant or lactating.\n* Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.\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 24 weeks\n* Who have been treated with systemic therapy within 8 weeks\n* Who have been treated with biologics within 12 weeks\n* Who have been treated with topical therapy during the wash-out and lead-in period.'}, 'identificationModule': {'nctId': 'NCT00884169', 'briefTitle': 'Study to Investigate the Efficacy and the Safety of M518101 in Psoriasis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Maruho Co., Ltd.'}, 'orgStudyIdInfo': {'id': 'M518101-EU03'}}, 'armsInterventionsModule': {'interventions': [{'name': 'M518101', 'type': 'DRUG', 'description': 'Proper quantity twice a day'}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Proper quantity twice a day'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': "St Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maruho Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'R&D Administration Department', 'oldOrganization': 'Maruho Co.,Ltd ã»Kyoto R&D Center'}}}}