A Study to Assess the Efficacy, Safety, and Pharmacokinetics of TB006 in Participants With Acute Ischemic Stroke

NCT05156827 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: TB006AIS2103
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke (AIS); TB006; stroke; efficacy; safety; pharmacokinetics; ischemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Recovery Success Measured by modified Rankin Scale (mRS) score of 0-1 on the final mRS assessment.

  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.

  Day 90

Secondary Outcomes (12)

• Percentage of Participants with Clinically Significant Improvement on the National Institutes of Health Stroke Scale (NIHSS)

  At Days 29, 57 and 85

• Change from Baseline in Neurological Function on the NIHSS

  Baseline and through Day 85

• Percentage of Participants with Clinically Significant Improvement on the mRS

  At Days 29, 57 and 85

• Change from Baseline in the Montreal Cognitive Assessment (MoCA) Total Score

  Baseline and at Days 29, 57, and 85

• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to Day 141

Study Arms (2)

TB006

EXPERIMENTAL

Participants will receive intravenous (IV) 3 infusions of 4000 milligrams (mg) TB006, one every 28 days (Q28D).

Drug: TB006

Placebo

PLACEBO COMPARATOR

Participants will receive an IV infusion of normal saline 500 milliliters (mL) Q28D.

Drug: Placebo

Interventions

TB006 DRUG

TB006 diluted in normal saline, administered through IV infusion over an hour

TB006

Placebo DRUG

Normal saline administered through IV infusion over an hour

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• TrueBinding, Inc.: lead

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Ischemia

Interventions

TB006

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• TrueBinding, Inc.

  TrueBinding, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 14, 2021
• Study Start: July 26, 2022
• Primary Completion: December 18, 2023
• Study Completion: December 18, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share