Study of BB-031 in Acute Ischemic Stroke Patients (RAISE) (RAISE)

A Multicenter, Double-blinded, Placebo-controlled, Single Ascending Dose, Two-part, Randomized, Phase 2 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BB-031 in Acute Ischemic Stroke Patients

The purpose of this study is to evaluate the safety and tolerability of ascending doses (Part A) and selected doses (Part B) of BB-031 in acute ischemic stroke patients presenting within 24 hours of stroke onset.

Participants will be randomized to receive one dose of either the investigational drug or placebo and will be followed for 90 days. A total of 156 patients are planned in this study.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Drug: Placebo; Drug: BB-031

Detailed Description

This is a two-part, randomized, placebo-controlled, double-blinded study in acute ischemic stroke patients. In Part A, approximately 36 participants will be randomized in a 3:1 ratio (investigational drug: placebo) into 1 of 3 planned ascending dose groups to determine the dose levels to be studied in Part B. Two dose levels will be chosen based upon a review of all available data including safety, PK, PD and preliminary efficacy. In Part B, approximately 120 participants will be randomized in a 1:1:1 ratio to receive a single dose of two dose levels of study drug or placebo.

All participants will be screened for participation after confirmed diagnosis of an anterior circulation ischemic stroke by neurovascular imaging. Enrolled participants will be followed for 90 days. Radiological outcomes will be assessed by a central blinded reviewer. A Data Safety Monitoring Committee will review safety and preliminary efficacy data throughout the study.

• Study Type: Interventional
• Enrollment (Estimated): 156
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Program Director; Phone Number: 9196184721; Email: snelson@baskingbiosciences.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical diagnosis of acute ischemic stroke
• 18 years or older
• Anterior circulation intra-cranial occlusion
• Onset of stroke symptoms within 24 hours of enrollment

Exclusion Criteria:

• Large volume ischemic stroke
• Intracranial hemorrhage on baseline imaging or previous intracranial hemorrhage
• Chronic intracranial occlusion
• Weight >125kg
• Administration of thrombolytic drug or glycoprotein IIb/IIIa inhibitors
• Ongoing clinically significant coagulopathy, history of bleeding disorder or other conditions for high-risk bleeding or active uncontrolled bleeding
• Prior stroke within 90 days
• Unable to undergo a contrast brain perfusion scan with either MRI or CT

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BB-031; A single dose of BB-031 will be administered via IV push over 1-3 minutes.	Drug: BB-031; Solution for injection; Other Names: DTRI-031
Placebo Comparator: Placebo; A single dose of matching placebo will be administered via IV push over 1-3 minutes	Drug: Placebo; 0.9% sodium chloride for injection; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic Intracranial Hemorrhage (sICH)	Proportion of participants having a sICH	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asymptomatic intracranial hemorrhage (non-symptomatic-ICH)	Proportion of participants having a non-symptomatic-ICH	24 hours
Adverse Events (AEs)	Incidence and severity of treatment-emergent AEs	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	All-cause mortality	30 days, 90 days
Pharmacokinetic (PK) Plasma Level Assessment	Plasma levels of study drug	72 hours
Pharmacokinetic (PK) Parameter	Cmax	72 hours
Pharmacodynamic (PD) Assessment	Level of free circulating von Willibrand Factor	72 hours
Pharmacodynamic (PD) Assessment	von Willibrand Factor activity	72 hours
Recanalization	Proportion of participants with recanalization	6 hours
Endovascular Thrombectomy (EVT)	Proportion of participants where EVT was not performed due to clinical improvement or evidence of recanalization	6 hours
Stroke lesion volume	Assessed by MRI or CT	24 hours
National Institutes of Health Stroke Scale (NIHSS) Score	Change from baseline score (total score 0 to 42, with 0 representing no abnormality	24 hours
Modified Rankins Scale (mRS) Score	Change from baseline score, where 0=no symptoms and 6=dead	Day 90
ICU length of stay	Duration of ICU stay	Up to Day 90
Hospitalization length of stay	Duration of hospitalization	Up to Day 90
Successful reperfusion after first pass EVT	Proportion of subjects with successful reperfusion after first pass EVT	6 hours

Collaborators and Investigators

• Sponsor: Basking Biosciences, Inc.
• Investigators: Principal Investigator: Michael D Hill, MD, University of Calgary; Principal Investigator: Shahid M Nimjee, MD, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 7, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Estimated): January 26, 2024

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Intracranial hemorrhage; Large vessel occlusion; Wake-up stroke
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: BB-031-CLIN-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No