Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-26 @ 8:56 PM
Study NCT ID:
NCT01301157
Status:
COMPLETED
Last Update Posted:
2015-11-05
First Post:
2011-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate the Efficacy and the Safety of M518101 in Plaque Psoriasis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C055085', 'term': 'calcipotriene'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 294}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'dispFirstSubmitDate': '2015-10-12', 'lastUpdateSubmitDate': '2015-10-12', 'studyFirstSubmitDate': '2011-02-18', 'dispFirstSubmitQcDate': '2015-10-12', 'studyFirstSubmitQcDate': '2011-02-18', 'dispFirstPostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'severity of plaque psoriasis', 'timeFrame': '8 weeks after dosing'}], 'secondaryOutcomes': [{'measure': 'Investigator global assessment', 'timeFrame': '8 weeks after dosing'}]}, 'conditionsModule': {'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the efficacy and safety of M518101 and the dose relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients.', 'detailedDescription': 'This study is to evaluate the efficacy and safety of M518101 and the dose response relationship among two doses of M518101 and placebo in male and female plaque psoriasis patients and to confirm the persistence of the effect of M518101.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Who are able and willing to give signed informed consent\n2. Who are male or females aged 18 years or older with plaque psoriasis confirmed by the Investigator.\n3. Who have less than 20% of body surface area (BSA) afflicted with plaques\n4. Who are neither pregnant nor breast-feeding, nor plan to become pregnant during the study.\n\nExclusion Criteria:\n\n1. Who have a history of allergy to vitamin D3 derivative preparations.\n2. Who have a history of relevant drug hypersensitivity.\n3. Who have a history of contact dermatitis induced by a topical medicine.\n4. Who are pregnant or lactating.\n5. Who have any renal or hepatic insufficiency, or clinically significant cardiac, renal or hepatic disease.\n6. Who are not deemed eligible as determined by medical history, physical examination or clinical laboratory safety tests.\n7. 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.\n8. Whose serum calcium levels exceed the upper limit of reference range\n9. Who have used any investigational medicinal product and/or participated in any clinical study within 60 days before the day of signing the ICF.\n10. Who have been treated with systemic therapy within 2 weeks before the day of signing the ICF and during the wash-out period.\n11. Who have been treated with biologics within 5 half-lives of the biologics before the day of randomization.\n12. Who have been treated with topical therapy during the wash-out period.'}, 'identificationModule': {'nctId': 'NCT01301157', 'briefTitle': 'Study to Investigate the Efficacy and the Safety of M518101 in Plaque Psoriasis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Maruho Co., Ltd.'}, 'orgStudyIdInfo': {'id': 'M518101-US01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '25ug M518101', 'interventionNames': ['Drug: M518101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dovonex', 'interventionNames': ['Drug: Dovonex']}, {'type': 'EXPERIMENTAL', 'label': '50ug M518101', 'interventionNames': ['Drug: M518101']}], 'interventions': [{'name': 'M518101', 'type': 'DRUG', 'description': 'Proper quantity twice a day', 'armGroupLabels': ['25ug M518101', '50ug M518101']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Proper quantity twice a day', 'armGroupLabels': ['Vehicle']}, {'name': 'Dovonex', 'type': 'DRUG', 'description': 'Proper quantity twice a day', 'armGroupLabels': ['Dovonex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama (UAB) Dermatology', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Coastal Carolina Research', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Sierra Medical Research', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Therapeutics Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United 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{'zip': '63117', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Central Dermatology', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University, Dermatology Clinical Trials Unit', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center, Section of Dermatology', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Skin Search of Rochester, Inc.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '11790', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'DermResearchCenter of New York, Inc', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27262', 'city': 'High 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'facility': 'Palmetto Clinical Trial Services, LLC', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '76011', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Arlington Research Center, Inc', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Center for Clinical Studies, Texas Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Dermatology Clinical Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Clinical Research Inc.', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Dermatology Associates', 'geoPoint': {'lat': 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