Clinical trial NCT05156827: A Study to Assess the Efficacy, Safety, and Pharmacokinetics of TB006 in Participants With Acute Ischemic Stroke
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke (AIS)
TB006
stroke
efficacy
safety
pharmacokinetics
ischemia
Lead sponsor: TrueBinding, Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) between 18 and 40 kilograms per meters squared (kg/m\^2), inclusive
* 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.
* 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.
* National Institute of Health Stroke Scale total score of 7 to 21, inclusive
* 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.

Exclusion Criteria:

* 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
* Lacunar or isolated brainstem or cerebellar stroke based on clinical assessment and available acute imaging studies performed under the standard of care
* Evidence of seizure at the onset of index stroke
* Evidence of acute myocardial infarction (MI) at Baseline, including any of the following:

  1. Acute ST elevation MI;
  2. Acute decompensated heart failure, or New York Heart Association Class III/IV heart failure;
  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.
  4. QT interval corrected using Bazett's formula (QTcB) \>520 milliseconds (msec).
* 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
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
Secondary outcomes:
measure: Percentage of Participants with Clinically Significant Improvement on the National Institutes of Health Stroke Scale (NIHSS)
timeFrame: At Days 29, 57 and 85
measure: Change from Baseline in Neurological Function on the NIHSS
timeFrame: Baseline and through Day 85
measure: Percentage of Participants with Clinically Significant Improvement on the mRS
timeFrame: At Days 29, 57 and 85
measure: Change from Baseline in the Montreal Cognitive Assessment (MoCA) Total Score
timeFrame: Baseline and at Days 29, 57, and 85
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
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
Other outcomes:
Locations:
Study officials:
affiliation: TrueBinding, Inc.
name: TrueBinding, Inc.
role: STUDY_DIRECTOR
References: