{ "FullStudy":{ "Rank":217930, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514981", "OrgStudyIdInfo":{ "OrgStudyId":"20080451" }, "Organization":{ "OrgFullName":"Amgen", "OrgClass":"INDUSTRY" }, "BriefTitle":"AMG 761 in Adults With Asthma", "OfficialTitle":"A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 761 in Subjects With Asthma" }, "StatusModule":{ "StatusVerifiedDate":"April 2014", "OverallStatus":"Terminated", "WhyStopped":"Administrative decision", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 19, 2011", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"April 16, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"April 21, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Amgen", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to determine that no significant safety issues will be identified following a single dose of AMG 761 in asthma subjects that would preclude further development of AMG 761." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Asthma" ] }, "KeywordList":{ "Keyword":[ "Asthma" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Basic Science", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"7", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"AMG 761", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: AMG 761" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"AMG 761", "InterventionDescription":"Single dose of AMG 761 on study day 1.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "AMG 761" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"Single dose of placebo on study day 1.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"The number of treatment emergent adverse events per subject including clinically significant changes in vital signs, physical examinations, laboratory safety tests and ECGs.", "PrimaryOutcomeTimeFrame":"16 weeks" },{ "PrimaryOutcomeMeasure":"The number of subjects with anti-AMG 761 antibodies after a single dose of AMG 761.", "PrimaryOutcomeTimeFrame":"16 weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"The maximum observed concentration, time to maximum concentration and the area under the serum concentration-time curve after a single dose of AMG 761.", "SecondaryOutcomeTimeFrame":"16 weeks" },{ "SecondaryOutcomeMeasure":"The circulating CD4+ CCR4+ T cell count.", "SecondaryOutcomeTimeFrame":"16 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy, with no history or evidence of clinically relevant medical or psychiatric disorders (with the exception of asthma) as determined by the investigator in consultation with the Amgen physician where medically appropriate\nImmunizations up to date, with a minimum of tetanus, diphtheria, pertussis (td/Tdap), pneumococcal (polysaccharide), influenza (during flu season) and H1N1 (where and when available) vaccinations, as determined by the principal investigator\nBody mass index (BMI) in the range of 18 to 35 kg/m2, inclusive\nIs a current non-smoker and has not used any tobacco products within the last 6 months and the cumulative smoking history must be ≤ 10 pack years\nClinically stable with a physician diagnosis of asthma for a minimum of 6 months prior to enrollment, and with no change in asthma treatment for at least 3 months prior to enrollment. As needed beta-agonist use (ie, PRN) should be considered a stable treatment\nDocumented history of atopy to oak, mite, ragweed, timothy grass, Alternaria mold, kochia pollen, aspergillus, or cottonwood within 18 months or positive atopy skin prick test for these specific allergens during the screening period\nAdditional inclusion criteria apply\n\nExclusion Criteria:\n\nPast history of serious skin rash requiring hospitalization\nActive, or history of (within 12 months of enrollment), acute viral infection of the skin (eg, herpes simplex, herpes zoster, or molluscum contagiosum)\nActive or history of psoriasis, or a first degree relative with active or known history of psoriasis\nFirst degree relatives with active or history of systemic lupus erythematosus or type 1 diabetes, rheumatoid arthritis or other active autoimmune disorder, as determined by the principal investigator\nHistory of life-threatening anaphylaxis\nExperienced an asthma exacerbation (defined as a disease episode resulting in treatment in an emergency room, hospitalization, or an episode treated with oral corticosteroids in dosage of at least 5 mg/day prednisone or equivalent for ≥ 1 week) during the 6 months prior to enrollment\nAdditional exclusion criteria apply", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"60 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"MD", "OverallOfficialAffiliation":"Amgen", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Research Site", "LocationCity":"Denver", "LocationState":"Colorado", "LocationZip":"80206", "LocationCountry":"United States" },{ "LocationFacility":"Research Site", "LocationCity":"Miami", "LocationState":"Florida", "LocationZip":"33143", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"AmgenTrials clinical trials website", "SeeAlsoLinkURL":"http://www.amgentrials.com" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"C000549035", "InterventionMeshTerm":"Mogamulizumab" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M264854", "InterventionBrowseLeafName":"Mogamulizumab", "InterventionBrowseLeafAsFound":"AMG 761", "InterventionBrowseLeafRelevance":"high" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000001249", "ConditionMeshTerm":"Asthma" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000001982", "ConditionAncestorTerm":"Bronchial Diseases" },{ "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" },{ "ConditionAncestorId":"D000008173", "ConditionAncestorTerm":"Lung Diseases, Obstructive" },{ "ConditionAncestorId":"D000008171", "ConditionAncestorTerm":"Lung Diseases" },{ "ConditionAncestorId":"D000012130", "ConditionAncestorTerm":"Respiratory Hypersensitivity" },{ "ConditionAncestorId":"D000006969", "ConditionAncestorTerm":"Hypersensitivity, Immediate" },{ "ConditionAncestorId":"D000006967", "ConditionAncestorTerm":"Hypersensitivity" },{ "ConditionAncestorId":"D000007154", "ConditionAncestorTerm":"Immune System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3137", "ConditionBrowseLeafName":"Asthma", "ConditionBrowseLeafAsFound":"Asthma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3840", "ConditionBrowseLeafName":"Bronchial Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9751", "ConditionBrowseLeafName":"Lung Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9753", "ConditionBrowseLeafName":"Lung Diseases, Obstructive", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8601", "ConditionBrowseLeafName":"Hypersensitivity", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13550", "ConditionBrowseLeafName":"Respiratory Hypersensitivity", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8603", "ConditionBrowseLeafName":"Hypersensitivity, Immediate", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8783", "ConditionBrowseLeafName":"Immune System Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"BC20", "ConditionBrowseBranchName":"Immune System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }