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

Phase 2

Recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: BB-031; Drug: Placebo

• Registration Number: NCT06226805
• Lead Sponsor: Basking Biosciences, Inc.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-01-07
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-26
• Study Start: 2024-07-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31
• Primary Completion: 2026-12
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 156

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BB-031	BB-031	A single dose of BB-031 will be administered via IV bolus injection
Placebo	Placebo	A single dose of matching placebo will be administered via IV bolus injection

Primary Outcome Measures

Name	Time	Method
Symptomatic Intracranial Hemorrhage (sICH)	24 hours	Proportion of participants having a sICH

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Mills Peninsula Medical Center; 🇺🇸 Burlingame, California, United States

MemorialCare Long Beach Medical Center; 🇺🇸 Long Beach, California, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

Baptist Health Medical Center; 🇺🇸 Jacksonville, Florida, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

The Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia

ProMedica Toledo Hospital; 🇺🇸 Toledo, Ohio, United States