Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-13 @ 11:13 AM
Study NCT ID:
NCT01510951
Status:
COMPLETED
Last Update Posted:
2013-03-27
First Post:
2011-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 811 in Subjects 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000604956', 'term': 'AMG 811'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-25', 'studyFirstSubmitDate': '2011-08-11', 'studyFirstSubmitQcDate': '2012-01-12', 'lastUpdatePostDateStruct': {'date': '2013-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the number of adverse events per subject, including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 811', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Evaluate the efficacy of AMG 811 as measured by the following: the proportion of subjects with a PASI 50, 75 and 90', 'timeFrame': '16 weeks'}, {'measure': 'Measure the area under the serum concentration curve versus time of AMG 811 after a single dose administration in subjects with moderate to severe psoriasis', 'timeFrame': '16 weeks'}, {'measure': 'Measure the peak serum concentration (Cmax) of AMG 811 after a single dose administration in subjects with moderate to severe psoriasis', 'timeFrame': '16 weeks'}]}, 'conditionsModule': {'keywords': ['AMGEN', 'PSORIASIS', 'SAFETY'], 'conditions': ['Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, tolerability, immunogenicity, and clinical effects of AMG 811 following single subcutaneous dose administration in subjects with moderate to severe psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 - 55 years old inclusive at Screening\n* Active but clinically stable, plaque psoriasis\n* Psoriasis involving ≥ 10% of the body surface area\n* A minimum PASI score of ≥ 10 obtained during the screening period\n* Additional inclusion criteria apply\n\nExclusion Criteria:\n\n* Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit\n* Evidence of skin conditions other than psoriasis (eg, eczema) at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of investigational product on psoriasis\n* Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject\n* Additional exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT01510951', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 811 in Subjects With Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 811 in Subjects With Moderate to Severe Psoriasis', 'orgStudyIdInfo': {'id': '20101147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO', 'interventionNames': ['Drug: AMG 811 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'AMG 811', 'interventionNames': ['Drug: AMG 811 or Placebo']}], 'interventions': [{'name': 'AMG 811 or Placebo', 'type': 'DRUG', 'description': 'Single dose subcutaneous administration of AMG 811 or placebo to adult subjects with psoriasis.', 'armGroupLabels': ['AMG 811', 'PLACEBO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4006', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Research Site', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Research Site', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '1010', 'city': 'Grafton, Auckland', 'country': 'New Zealand', 'facility': 'Research Site'}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}