Clinical trial NCT06226805: Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Keywords: Stroke
Wake-up stroke
Large vessel occlusion
Intracranial hemorrhage
Lead sponsor: Basking Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-26
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will receive a single dose of blinded investigational drug or placebo.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptomatic Intracranial Hemorrhage (sICH)
timeFrame: 24 hours
Secondary outcomes:
measure: Asymptomatic intracranial hemorrhage (non-symptomatic-ICH)
timeFrame: 24 hours
measure: Adverse Events (AEs)
timeFrame: 24 hours
Other outcomes:
measure: Mortality
timeFrame: 30 days, 90 days
measure: Pharmacokinetic (PK) Plasma Level Assessment
timeFrame: 48 hours
measure: Pharmacokinetic (PK) Parameter
timeFrame: 48 hours
measure: Pharmacodynamic (PD) Assessment
timeFrame: 72 hours
measure: Pharmacodynamic (PD) Assessment
timeFrame: 72 hours
measure: Recanalization
timeFrame: 6 hours
measure: Endovascular Thrombectomy (EVT)
timeFrame: 6 hours
measure: Stroke lesion volume
timeFrame: 24 hours
measure: National Institutes of Health Stroke Scale (NIHSS) Score
timeFrame: 24 hours
measure: Modified Rankin Scale (mRS) Score
timeFrame: Day 90
measure: ICU length of stay
timeFrame: Up to Day 90
measure: Hospitalization length of stay
timeFrame: Up to Day 90
measure: Successful reperfusion after first pass EVT
timeFrame: 6 hours
Locations:
city: Burlingame
country: United States
facility: Mills Peninsula Medical Center
state: California
city: Long Beach
country: United States
facility: MemorialCare Long Beach Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Jacksonville
country: United States
facility: Baptist Health Medical Center
state: Florida
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Michael D Hill, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Shahid M Nimjee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: