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

TrueBinding

Status and phase: Withdrawn; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Drug: TB006; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05156827

TB006AIS2103

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

TB006

Experimental group

Description:

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

Treatment:

Drug: TB006

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo