{
  "FullStudy":{
    "Rank":218237,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510951",
          "OrgStudyIdInfo":{
            "OrgStudyId":"20101147"
          },
          "Organization":{
            "OrgFullName":"Amgen",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of AMG 811 in Subjects With Psoriasis",
          "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"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"October 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"October 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"August 11, 2011",
          "StudyFirstSubmitQCDate":"January 12, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 18, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 25, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 27, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Amgen",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{},
        "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."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Psoriasis"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "AMGEN",
              "PSORIASIS",
              "SAFETY"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Basic Science",
            "DesignMaskingInfo":{
              "DesignMasking":"Triple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"9",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"PLACEBO",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: AMG 811 or Placebo"
                  ]
                }
              },{
                "ArmGroupLabel":"AMG 811",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: AMG 811 or Placebo"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"AMG 811 or Placebo",
                "InterventionDescription":"Single dose subcutaneous administration of AMG 811 or placebo to adult subjects with psoriasis.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "AMG 811",
                    "PLACEBO"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"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",
                "PrimaryOutcomeTimeFrame":"16 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Evaluate the efficacy of AMG 811 as measured by the following: the proportion of subjects with a PASI 50, 75 and 90",
                "SecondaryOutcomeTimeFrame":"16 weeks"
              },{
                "SecondaryOutcomeMeasure":"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",
                "SecondaryOutcomeTimeFrame":"16 weeks"
              },{
                "SecondaryOutcomeMeasure":"Measure the peak serum concentration (Cmax) of AMG 811 after a single dose administration in subjects with moderate to severe psoriasis",
                "SecondaryOutcomeTimeFrame":"16 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\n18 - 55 years old inclusive at Screening\nActive but clinically stable, plaque psoriasis\nPsoriasis involving ≥ 10% of the body surface area\nA minimum PASI score of ≥ 10 obtained during the screening period\nAdditional inclusion criteria apply\n\nExclusion Criteria:\n\nActive guttate, erythrodermic, or pustular psoriasis at the time of the screening visit\nEvidence 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\nAny condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject\nAdditional exclusion criteria apply",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"MD",
                "OverallOfficialAffiliation":"Amgen",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Research Site",
                "LocationCity":"Herston",
                "LocationState":"Queensland",
                "LocationZip":"4006",
                "LocationCountry":"Australia"
              },{
                "LocationFacility":"Research Site",
                "LocationCity":"Nedlands",
                "LocationState":"Western Australia",
                "LocationZip":"6009",
                "LocationCountry":"Australia"
              },{
                "LocationFacility":"Research Site",
                "LocationCity":"Christchurch",
                "LocationZip":"8011",
                "LocationCountry":"New Zealand"
              },{
                "LocationFacility":"Research Site",
                "LocationCity":"Grafton, Auckland",
                "LocationZip":"1010",
                "LocationCountry":"New Zealand"
              }
            ]
          }
        },
        "ReferencesModule":{
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"AmgenTrials clinical trials website",
                "SeeAlsoLinkURL":"http://www.amgentrials.com"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000011565",
                "ConditionMeshTerm":"Psoriasis"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000017444",
                "ConditionAncestorTerm":"Skin Diseases, Papulosquamous"
              },{
                "ConditionAncestorId":"D000012871",
                "ConditionAncestorTerm":"Skin Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M13005",
                "ConditionBrowseLeafName":"Psoriasis",
                "ConditionBrowseLeafAsFound":"Psoriasis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14257",
                "ConditionBrowseLeafName":"Skin Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M18296",
                "ConditionBrowseLeafName":"Skin Diseases, Papulosquamous",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC17",
                "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}