Nctid:
NCT06226805
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000020521", "term"=>"Stroke"}, {"id"=>"D000083242", "term"=>"Ischemic Stroke"}, {"id"=>"D000002544", "term"=>"Cerebral Infarction"}, {"id"=>"D000007511", "term"=>"Ischemia"}], "ancestors"=>[{"id"=>"D000002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000020520", "term"=>"Brain Infarction"}, {"id"=>"D000002545", "term"=>"Brain Ischemia"}, {"id"=>"D000007238", "term"=>"Infarction"}, {"id"=>"D000009336", "term"=>"Necrosis"}], "browseLeaves"=>[{"id"=>"M9556", "name"=>"Hemorrhage", "relevance"=>"LOW"}, {"id"=>"M22306", "name"=>"Stroke", "asFound"=>"Stroke", "relevance"=>"HIGH"}, {"id"=>"M10543", "name"=>"Ischemia", "asFound"=>"Ischemic", "relevance"=>"HIGH"}, {"id"=>"M2400", "name"=>"Ischemic Stroke", "asFound"=>"Ischemic Stroke", "relevance"=>"HIGH"}, {"id"=>"M22113", "name"=>"Intracranial Hemorrhages", "relevance"=>"LOW"}, {"id"=>"M10282", "name"=>"Infarction", "relevance"=>"LOW"}, {"id"=>"M5793", "name"=>"Cerebral Infarction", "asFound"=>"Ischemic Stroke", "relevance"=>"HIGH"}, {"id"=>"M5810", "name"=>"Cerebrovascular Disorders", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M22305", "name"=>"Brain Infarction", "relevance"=>"LOW"}, {"id"=>"M5794", "name"=>"Brain Ischemia", "relevance"=>"LOW"}, {"id"=>"M12284", "name"=>"Necrosis", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M21860", "name"=>"Pharmaceutical Solutions", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Participants will receive a single dose of blinded investigational drug or placebo."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>156}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-07-31", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2027-03", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-08", "studyFirstSubmitDate"=>"2024-01-07", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-19", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-12", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Mortality", "timeFrame"=>"30 days, 90 days", "description"=>"All-cause mortality"}, {"measure"=>"Pharmacokinetic (PK) Plasma Level Assessment", "timeFrame"=>"48 hours", "description"=>"Plasma levels of study drug"}, {"measure"=>"Pharmacokinetic (PK) Parameter", "timeFrame"=>"48 hours", "description"=>"Cmax"}, {"measure"=>"Pharmacodynamic (PD) Assessment", "timeFrame"=>"72 hours", "description"=>"Level of free circulating von Willibrand Factor"}, {"measure"=>"Pharmacodynamic (PD) Assessment", "timeFrame"=>"72 hours", "description"=>"von Willibrand Factor activity"}, {"measure"=>"Recanalization", "timeFrame"=>"6 hours", "description"=>"Proportion of participants with recanalization"}, {"measure"=>"Endovascular Thrombectomy (EVT)", "timeFrame"=>"6 hours", "description"=>"Proportion of participants where EVT was not performed due to clinical improvement or evidence of recanalization"}, {"measure"=>"Stroke lesion volume", "timeFrame"=>"24 hours", "description"=>"Assessed by MRI or CT"}, {"measure"=>"National Institutes of Health Stroke Scale (NIHSS) Score", "timeFrame"=>"24 hours", "description"=>"Change from baseline score (total score 0 to 42, with 0 representing no abnormality"}, {"measure"=>"Modified Rankins Scale (mRS) Score", "timeFrame"=>"Day 90", "description"=>"Change from baseline score, where 0=no symptoms and 6=dead"}, {"measure"=>"ICU length of stay", "timeFrame"=>"Up to Day 90", "description"=>"Duration of ICU stay"}, {"measure"=>"Hospitalization length of stay", "timeFrame"=>"Up to Day 90", "description"=>"Duration of hospitalization"}, {"measure"=>"Successful reperfusion after first pass EVT", "timeFrame"=>"6 hours", "description"=>"Proportion of subjects with successful reperfusion after first pass EVT"}], "primaryOutcomes"=>[{"measure"=>"Symptomatic Intracranial Hemorrhage (sICH)", "timeFrame"=>"24 hours", "description"=>"Proportion of participants having a sICH"}], "secondaryOutcomes"=>[{"measure"=>"Asymptomatic intracranial hemorrhage (non-symptomatic-ICH)", "timeFrame"=>"24 hours", "description"=>"Proportion of participants having a non-symptomatic-ICH"}, {"measure"=>"Adverse Events (AEs)", "timeFrame"=>"24 hours", "description"=>"Incidence and severity of treatment-emergent AEs"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Stroke", "Wake-up stroke", "Large vessel occlusion", "Intracranial hemorrhage"], "conditions"=>["Acute Ischemic Stroke"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to evaluate the safety and tolerability of ascending doses (Part A) and selected doses (Part B) of BB-031 in acute ischemic stroke patients presenting within 24 hours of stroke onset.\n\nParticipants will be randomized to receive one dose of either the investigational drug or placebo and will be followed for 90 days. A total of 156 patients are planned in this study.", "detailedDescription"=>"This is a two-part, randomized, placebo-controlled, double-blinded study in acute ischemic stroke patients. In Part A, approximately 36 participants will be randomized in a 3:1 ratio (investigational drug: placebo) into 1 of 3 planned ascending dose groups to determine the dose levels to be studied in Part B. Two dose levels will be chosen based upon a review of all available data including safety, PK, PD and preliminary efficacy. In Part B, approximately 120 participants will be randomized in a 1:1:1 ratio to receive a single dose of two dose levels of study drug or placebo.\n\nAll participants will be screened for participation after confirmed diagnosis of an anterior circulation ischemic stroke by neurovascular imaging. Enrolled participants will be followed for 90 days. Radiological outcomes will be assessed by a central blinded reviewer. A Data Safety Monitoring Committee will review safety and preliminary efficacy data throughout the study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Clinical diagnosis of acute ischemic stroke\n* 18 years or older\n* Anterior circulation intra-cranial occlusion\n* Onset of stroke symptoms within 24 hours of enrollment\n\nExclusion Criteria:\n\n* Large volume ischemic stroke\n* Intracranial hemorrhage on baseline imaging or previous intracranial hemorrhage\n* Chronic intracranial occlusion\n* Weight \\>125kg\n* Administration of thrombolytic drug or glycoprotein IIb/IIIa inhibitors\n* Ongoing clinically significant coagulopathy, history of bleeding disorder or other conditions for high-risk bleeding or active uncontrolled bleeding\n* Prior stroke within 90 days\n* Unable to undergo a contrast brain perfusion scan with either MRI or CT"}, "identificationModule"=>{"nctId"=>"NCT06226805", "acronym"=>"RAISE", "briefTitle"=>"Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Basking Biosciences, Inc."}, "officialTitle"=>"A Multicenter, Double-blinded, Placebo-controlled, Single Ascending Dose, Two-part, Randomized, Phase 2 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BB-031 in Acute Ischemic Stroke Patients", "orgStudyIdInfo"=>{"id"=>"BB-031-CLIN-201"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"BB-031", "description"=>"A single dose of BB-031 will be administered via IV bolus injection", "interventionNames"=>["Drug: BB-031"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "description"=>"A single dose of matching placebo will be administered via IV bolus injection", "interventionNames"=>["Drug: Placebo"]}], "interventions"=>[{"name"=>"BB-031", "type"=>"DRUG", "otherNames"=>["DTRI-031"], "description"=>"Solution for injection", "armGroupLabels"=>["BB-031"]}, {"name"=>"Placebo", "type"=>"DRUG", "otherNames"=>["Saline"], "description"=>"0.9% sodium chloride for injection", "armGroupLabels"=>["Placebo"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"43604", "city"=>"Toledo", "state"=>"Ohio", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Study Coordinator", "role"=>"CONTACT"}], "facility"=>"ProMedica Toledo Hospital", "geoPoint"=>{"lat"=>41.66394, "lon"=>-83.55521}}], "centralContacts"=>[{"name"=>"Program Director", "role"=>"CONTACT", "email"=>"snelson@baskingbiosciences.com", "phone"=>"9196184721"}], "overallOfficials"=>[{"name"=>"Michael D Hill, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Calgary"}, {"name"=>"Shahid M Nimjee, MD, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Ohio State University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Basking Biosciences, Inc.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
