Acute Ischemic StrokePhase 2RAISENCT06226805
Study of BB-031 in Acute Ischemic Stroke Patients (RAISE)
A Phase 2 study testing BB-031 in people with Acute Ischemic Stroke, run by Basking Biosciences, Inc. at 25 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- BB-031
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 25 sitesin 3 countries
- Study dates
- 31 Jul 2024to Sep 2027
- Phase
- Phase 2
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute ischemic stroke
- 18 years or older
- Anterior circulation intra-cranial occlusion
- NIHSS score >3
- Onset of stroke symptoms within 24 hours of enrollment
Who cannot join
- 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
Show all 10Show fewer
- Prior stroke within 90 days
- Unable to undergo a CTA or MRA
- Known severe renal disease
- Known hypersensitivity to any constituent of BB-031
Trial locations and contacts
25 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 3 countries
United States15 sites, 10 recruiting
- Withdrawn
Mills Peninsula Medical Center
Burlingame, California, 94010
- Recruiting
Cooper University Hospital
Camden, New Jersey, 08103
Study Coordinator
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Study Coordinator
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Study Coordinator
- Recruiting
Valley Baptist Medical Center - Harlingen
Harlingen, Texas, 78550
Study Coordinator
- Terminated
Memorial Hermann Hospital
Houston, Texas, 77030
- Terminated
Baptist Health Medical Center
Jacksonville, Florida, 32207
- Withdrawn
MemorialCare Long Beach Medical Center
Long Beach, California, 90806
- Recruiting
WakeMed
Raleigh, North Carolina, 27610
Study Coordinator
- Withdrawn
California Pacific Medical Center
San Francisco, California, 94109
- Recruiting
HonorHealth Bob Bove Neuroscience Institute
Scottsdale, Arizona, 85251
Study Coordinator
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63110
Study Coordinator
- Recruiting
ProMedica Toledo Hospital
Toledo, Ohio, 43604
Study Coordinator
- Recruiting
Mercy Health St. Vincent Medical Center
Toledo, Ohio, 43608
Study Coordinator
- Recruiting
Pacific Neurosciences Institute at Saint John's Physician Partners
Torrance, California, 90503
Study Coordinator
Australia6 sites, 5 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Study Coordinator
- Terminated
Monash Medical Centre
Clayton, Victoria, 3168
- Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Study Coordinator
- Recruiting
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Study Coordinator
- Recruiting
The Royal Melbourne Hospital
Parkville, Victoria, 3050
Study Coordinator
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Study Coordinator
Canada4 sites, 4 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N2T9
Study Coordinator
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 2G3
Study Coordinator
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9
Study Coordinator
- Recruiting
Vancouver Stroke Program
Vancouver, British Columbia, V5Z1M9
Research Coordinator
About this study
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
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 228 patients are planned in this study.
Read the detailed description
This is a two-part, randomized, placebo-controlled, double-blinded study in acute ischemic stroke patients. In Part A, up to 48 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 180 participants will be randomized to receive a single dose of two sequential 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 as outlined in the protocol.
- Conditions
- Acute Ischemic Stroke
- Being tested
- BB-031, Placebo
- Keywords
- Stroke, Wake-up stroke, Large vessel occlusion, Intracranial hemorrhage
- Medical subject headings
- Ischemic Stroke, Stroke, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BB-031Drug
Also called DTRI-031
Solution for injection
PlaceboDrug
Also called Saline
0.9% sodium chloride for injection
| Study group | Role | What they receive |
|---|---|---|
| BB-031 | Experimental | A single dose of BB-031 will be administered via IV bolus injection Receives: Drug: BB-031 |
| Placebo | Placebo comparator | A single dose of matching placebo will be administered via IV bolus injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic Intracranial Hemorrhage (sICH)
Proportion of participants having a sICH
Measured: 24 hours
Secondary outcomes (2)
Asymptomatic intracranial hemorrhage (non-symptomatic-ICH)
Proportion of participants having a non-symptomatic-ICH
Measured: 24 hours
Adverse Events (AEs)
Incidence and severity of treatment-emergent AEs
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start31 Jul 2024
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will receive a single dose of blinded investigational drug or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basking Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael D Hill, MD, Principal investigator, University of CalgaryShahid M Nimjee, MD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226805
- Sponsor's protocol ID
- BB-031-CLIN-201
- Acronym
- RAISE
- Status last verified
- Oct 2026
- First submitted
- 7 Jan 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No