Acute Ischemic StrokePhase 2NCT05156827
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of TB006 in Participants With Acute Ischemic Stroke
A Phase 2 study testing TB006 in people with Acute Ischemic Stroke, run by TrueBinding, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- TB006
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 26 Jul 2022to 18 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
- 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.
About this study
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
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
- Being tested
- TB006, Placebo
- Keywords
- Acute Ischemic Stroke (AIS), TB006, stroke, efficacy, safety, pharmacokinetics, ischemia
- Medical subject headings
- Ischemic Stroke, Stroke, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB006Drug
TB006 diluted in normal saline, administered through IV infusion over an hour
PlaceboDrug
Normal saline administered through IV infusion over an hour
| Study group | Role | What they receive |
|---|---|---|
| TB006 | Experimental | Participants will receive intravenous (IV) 3 infusions of 4000 milligrams (mg) TB006, one every 28 days (Q28D). Receives: Drug: TB006 |
| Placebo | Placebo comparator | Participants will receive an IV infusion of normal saline 500 milliliters (mL) Q28D. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 90
Secondary outcomes (12)
Percentage of Participants with Clinically Significant Improvement on the National Institutes of Health Stroke Scale (NIHSS)
Clinically significant improvement is defined as a 4-point decrease on the NIHSS
Measured: At Days 29, 57 and 85
Change from Baseline in Neurological Function on the NIHSS
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.
Measured: Baseline and through Day 85
Percentage of Participants with Clinically Significant Improvement on the mRS
Clinically Significant Improvement is defined as 1-point decrease on the mRS
Measured: At Days 29, 57 and 85
Change from Baseline in the Montreal Cognitive Assessment (MoCA) Total Score
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.
Measured: Baseline and at Days 29, 57, and 85
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to Day 141
Number of Participants with Clinically Significant Clinical Laboratory Parameter Values
Measured: Up to Day 141
Number of Participants with Clinically Significant Vital Sign Values
Measured: Up to Day 141
Number of Participants with Clinically Significant 12-Lead Electrocardiogram Findings
Measured: Up to Day 141
Number of participants with Columbia Suicide Severity Rating Scale (C-SSRS) Score
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.
Measured: Up to Day 141
Number of Participants with Clinically Significant Physical Examination Findings
Measured: Up to Day 141
Number of Participants with Anti-drug Antibodies
Measured: Up to Day 141
Plasma concentration of TB006
Measured: Pre-dose and post-dose on Days 1, 29, 57, 85 and 141
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start26 Jul 2022
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- TrueBinding, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- TrueBinding, Inc., Study director, TrueBinding, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156827
- Sponsor's protocol ID
- TB006AIS2103
- Status last verified
- Jan 2024
- First submitted
- 1 Dec 2021
- Last updated
- 12 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05156827
- Acronym / sponsor ID
- TB006AIS2103
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke (AIS), TB006, stroke, efficacy, safety, pharmacokinetics, ischemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TrueBinding, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TB006 | Experimental | Drug: TB006Participants will receive intravenous (IV) 3 infusions of 4000 milligrams (mg) TB006, one every 28 days (Q28D). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive an IV infusion of normal saline 500 milliliters (mL) Q28D. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TB006TB006 diluted in normal saline, administered through IV infusion over an hour | Drug | TB006 |
| PlaceboNormal saline administered through IV infusion over an hour | Drug | Placebo |
Primary outcome
Percentage of Participants with Recovery Success Measured by modified Rankin Scale (mRS) score of 0-1 on the final mRS assessment.
Time frame: Day 90
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.
12 secondary outcomes
Percentage of Participants with Clinically Significant Improvement on the National Institutes of Health Stroke Scale (NIHSS)
Time frame: At Days 29, 57 and 85
Change from Baseline in Neurological Function on the NIHSS
Time frame: Baseline and through Day 85
Percentage of Participants with Clinically Significant Improvement on the mRS
Time frame: At Days 29, 57 and 85
Change from Baseline in the Montreal Cognitive Assessment (MoCA) Total Score
Time frame: Baseline and at Days 29, 57, and 85
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 141
Number of Participants with Clinically Significant Clinical Laboratory Parameter Values
Time frame: Up to Day 141
Number of Participants with Clinically Significant Vital Sign Values
Time frame: Up to Day 141
Number of Participants with Clinically Significant 12-Lead Electrocardiogram Findings
Time frame: Up to Day 141
Number of participants with Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Up to Day 141
Number of Participants with Clinically Significant Physical Examination Findings
Time frame: Up to Day 141
Number of Participants with Anti-drug Antibodies
Time frame: Up to Day 141
Plasma concentration of TB006
Time frame: Pre-dose and post-dose on Days 1, 29, 57, 85 and 141
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TrueBinding, Inc. study director
TrueBinding, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TB006 in people with Acute Ischemic Stroke, run by TrueBinding, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants with Recovery Success Measured by modified Rankin Scale (mRS) score of 0-1 on the final mRS assessment. (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.