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

Acute Ischemic Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06226805
• Other study ID #: BB-031-CLIN-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: March 2027

Study information

• Verified date: January 2024
• Source: Basking Biosciences, Inc.
• Contact: Program Director
• Phone: 9196184721
• Email: snelson[@]baskingbiosciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 156
• Est. completion date: March 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• BB-031
Solution for injection
• Placebo
0.9% sodium chloride for injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Basking Biosciences, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	All-cause mortality	30 days, 90 days
Other	Pharmacokinetic (PK) Plasma Level Assessment	Plasma levels of study drug	72 hours
Other	Pharmacokinetic (PK) Parameter	Cmax	72 hours
Other	Pharmacodynamic (PD) Assessment	Level of free circulating von Willibrand Factor	72 hours
Other	Pharmacodynamic (PD) Assessment	von Willibrand Factor activity	72 hours
Other	Recanalization	Proportion of participants with recanalization	6 hours
Other	Endovascular Thrombectomy (EVT)	Proportion of participants where EVT was not performed due to clinical improvement or evidence of recanalization	6 hours
Other	Stroke lesion volume	Assessed by MRI or CT	24 hours
Other	National Institutes of Health Stroke Scale (NIHSS) Score	Change from baseline score (total score 0 to 42, with 0 representing no abnormality	24 hours
Other	Modified Rankins Scale (mRS) Score	Change from baseline score, where 0=no symptoms and 6=dead	Day 90
Other	ICU length of stay	Duration of ICU stay	Up to Day 90
Other	Hospitalization length of stay	Duration of hospitalization	Up to Day 90
Other	Successful reperfusion after first pass EVT	Proportion of subjects with successful reperfusion after first pass EVT	6 hours
Primary	Symptomatic Intracranial Hemorrhage (sICH)	Proportion of participants having a sICH	24 hours
Secondary	Asymptomatic intracranial hemorrhage (non-symptomatic-ICH)	Proportion of participants having a non-symptomatic-ICH	24 hours
Secondary	Adverse Events (AEs)	Incidence and severity of treatment-emergent AEs	24 hours