Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
Study NCT ID:
NCT05156827
Status:
WITHDRAWN
Last Update Posted:
2024-01-12
First Post:
2021-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of TB006 in Participants With Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000715407', 'term': 'TB006'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Business decision', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-10', 'studyFirstSubmitDate': '2021-12-01', 'studyFirstSubmitQcDate': '2021-12-01', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants with Recovery Success Measured by modified Rankin Scale (mRS) score of 0-1 on the final mRS assessment.', 'timeFrame': 'Day 90', 'description': 'The Modified Rankin Scale (mRS) measures neurological disability or dependence of participants with stroke on a scale of 0 to 6 and scores indicate the following: 0 - No symptoms; 1 - No significant disability; 2 - Slight disability; 3 - Moderate disability; 4 - Moderately severe disability; 5 - Severe disability; 6 - Dead. Higher score indicates worse condition.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants with Clinically Significant Improvement on the National Institutes of Health Stroke Scale (NIHSS)', 'timeFrame': 'At Days 29, 57 and 85', 'description': 'Clinically significant improvement is defined as a 4-point decrease on the NIHSS'}, {'measure': 'Change from Baseline in Neurological Function on the NIHSS', 'timeFrame': 'Baseline and through Day 85', 'description': 'The NIHSS is composed of 11 items, each of which rates a specific parameter of ability or function. Each item is rated on a scale of 0 to 4. A score of 0 indicates normal function, with higher scores indicating greater degree of impairment. The individual item scores are added to calculate the NIHSS total score. The minimum score being a 0 (no impairment) and maximum possible score is 42 (death). Higher scores indicate worse condition.'}, {'measure': 'Percentage of Participants with Clinically Significant Improvement on the mRS', 'timeFrame': 'At Days 29, 57 and 85', 'description': 'Clinically Significant Improvement is defined as 1-point decrease on the mRS'}, {'measure': 'Change from Baseline in the Montreal Cognitive Assessment (MoCA) Total Score', 'timeFrame': 'Baseline and at Days 29, 57, and 85', 'description': 'The MoCA is a brief screening instrument designed to assess mild cognitive impairment in a variety of participant conditions. The MoCA assesses eight cognitive domains: visuospatial ability, executive function, short-term memory recall, attention, concentration, working memory, language, and orientation to time and space. Scores on the MoCA range from 0 to 30, with lower scores indicating greater impairment.'}, {'measure': 'Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Up to Day 141'}, {'measure': 'Number of Participants with Clinically Significant Clinical Laboratory Parameter Values', 'timeFrame': 'Up to Day 141'}, {'measure': 'Number of Participants with Clinically Significant Vital Sign Values', 'timeFrame': 'Up to Day 141'}, {'measure': 'Number of Participants with Clinically Significant 12-Lead Electrocardiogram Findings', 'timeFrame': 'Up to Day 141'}, {'measure': 'Number of participants with Columbia Suicide Severity Rating Scale (C-SSRS) Score', 'timeFrame': 'Up to Day 141', 'description': "The C-SSRS is a suicidal ideation and behavior rating scale with yes/no responses. For each of the 5 items of the C-SSRS related to suicidal ideation intensity, an individual's degree of suicidal ideation is rated on a 0-5 scale with 0: no suicidal behavior and 5: active suicidal ideation. The total score is the sum of the 5 intensity item scores (total score ranges from 0 to 25). Higher scores in the scale indicate greater disease severity."}, {'measure': 'Number of Participants with Clinically Significant Physical Examination Findings', 'timeFrame': 'Up to Day 141'}, {'measure': 'Number of Participants with Anti-drug Antibodies', 'timeFrame': 'Up to Day 141'}, {'measure': 'Plasma concentration of TB006', 'timeFrame': 'Pre-dose and post-dose on Days 1, 29, 57, 85 and 141'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute Ischemic Stroke (AIS)', 'TB006', 'stroke', 'efficacy', 'safety', 'pharmacokinetics', 'ischemia'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'This multi-center, randomized, parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of TB006 in participants with an Acute Ischemic Stroke (AIS) event with 57 days of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body Mass Index (BMI) between 18 and 40 kilograms per meters squared (kg/m\\^2), inclusive\n* Clinical diagnosis of AIS in anterior circulation, supported by evidence of a new stroke on acute brain computed tomography (CT) or magnetic resonance imaging (MRI) consistent with the clinical diagnosis.\n* Able to be randomized and dosed within 7 days of index stroke event. The last known awake time will be used for participants whose stoke occurred during sleep.\n* National Institute of Health Stroke Scale total score of 7 to 21, inclusive\n* Participants may have received standard of care therapy including recombinant tissue plasminogen activator (r-tPA), thrombectomy, mannitol, hypertonic saline, and other treatments per local guidelines as determined by the Investigator. Participants who have received r-tPA within the first day of their stroke event are eligible. However, study drug administration must begin more than 24 hours following r-tPA administration.\n\nExclusion Criteria:\n\n* Evidence of severe stroke on imaging (e.g., sulcal effacement or blurring of gray-white junction in greater than 1/3 of middle cerebral artery \\[MCA\\] territory, Alberta Stroke Program Early CT \\[ASPECT\\] score of 0 to 4 based on head CT, acute infarct volume on MRI diffusion weighed imaging ≥70 mL based on acute imaging studies performed under the standard of care\n* Lacunar or isolated brainstem or cerebellar stroke based on clinical assessment and available acute imaging studies performed under the standard of care\n* Evidence of seizure at the onset of index stroke\n* Evidence of acute myocardial infarction (MI) at Baseline, including any of the following:\n\n 1. Acute ST elevation MI;\n 2. Acute decompensated heart failure, or New York Heart Association Class III/IV heart failure;\n 3. Admission for an acute coronary syndrome, MI, cardiac arrest, or non-voluntary coronary intervention (percutaneous coronary intervention or coronary artery surgery) within the past 3 months.\n 4. QT interval corrected using Bazett's formula (QTcB) \\>520 milliseconds (msec).\n* Evidence of acute intracranial or subarachnoid hemorrhage or evidence of active bleeding based on acute brain CT or MRI performed under the standard of care. However, petechial hemorrhages of ≤ 1 centimeter (cm) are not exclusionary.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT05156827', 'briefTitle': 'A Study to Assess the Efficacy, Safety, and Pharmacokinetics of TB006 in Participants With Acute Ischemic Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'TrueBinding, Inc.'}, 'officialTitle': 'A Phase 2 Double-blind, Randomized, Multi-center, Parallel-group Study to Assess the Efficacy, Safety, and Pharmacokinetics of TB006 in Patients With Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': 'TB006AIS2103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TB006', 'description': 'Participants will receive intravenous (IV) 3 infusions of 4000 milligrams (mg) TB006, one every 28 days (Q28D).', 'interventionNames': ['Drug: TB006']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive an IV infusion of normal saline 500 milliliters (mL) Q28D.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TB006', 'type': 'DRUG', 'description': 'TB006 diluted in normal saline, administered through IV infusion over an hour', 'armGroupLabels': ['TB006']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Normal saline administered through IV infusion over an hour', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'TrueBinding, Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'TrueBinding, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TrueBinding, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}