Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) (BEACH)

• ClinicalTrials.gov Identifier: NCT05020535
• Recruitment Status: Recruiting
• First Posted: August 25, 2021
• Last Update Posted: December 12, 2023
• Sponsor: Johns Hopkins University
• Collaborators: University of Kentucky; National Institute on Aging (NIA)
• Information provided by (Responsible Party): Johns Hopkins University

Tracking Information

• First Submitted Date: August 19, 2021
• First Posted Date: August 25, 2021
• Last Update Posted Date: December 12, 2023
• Actual Study Start Date: October 10, 2022
• Estimated Primary Completion Date: December 25, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 19, 2021)

Difference in the proportion of all cause-morality between arms [ Time Frame: 7 days post-randomization ]

Assess the safety and tolerability of MW189 for patients as determined by the rate of death during the treatment period.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)
• Official Title: Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) Phase 2a Trial
• Brief Summary: This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH).

Detailed Description

This first-in-patient phase 2a pilot study will assess the safety and tolerability of MW01-6-189WH (hereafter called MW189) in patients with Intracerebral Hemorrhage (ICH).

This study will monitor exploratory radiographic and clinical endpoints, explore the use of biochemical biomarkers to demonstrate target engagement and biological response to a potential new therapy targeted to neuroinflammation and synaptic dysfunction mechanisms.

MW189 is a novel small molecule drug candidate developed as a selective suppressor of disease-and injury-induced proinflammatory cytokine overproduction associated with destructive neuroinflammation/synaptic dysfunction cycles. In animal models of acute brain injuries such as ICH and Traumatic Brain Injury (TBI), MW189 attenuates neuroinflammation, reduces cerebral edema, and improves functional and cognitive performance. The investigators seek to establish if these targets are modified in humans with ICH.

• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Parallel 1:1

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Participants, study staff, analytic staff (to patient identifiers), sponsor staff (only to treatment allocation, unblinded to enable handling and review of data and drug accountability prior to database lock)

Primary Purpose: Treatment

• Condition: Intracerebral Hemorrhage

Intervention

• Drug: MW189
  MW189 (0.25 mg/kg) is administered within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)
• Other: Saline
  Administration of saline within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)

Study Arms

• Experimental: Experimental
  MW189 (0.25 mg/kg) is administered within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)
  Intervention: Drug: MW189
• Placebo Comparator: Control
  Administration of saline within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)
  Intervention: Other: Saline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 19, 2021): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: October 1, 2026
• Estimated Primary Completion Date: December 25, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Confirmed diagnosis of spontaneous, non-traumatic ICH.
• 10 mL ≤ ICH ≤ 60 mL (confirmed via diagnostic and stability CT scans utilizing volumetric assessment)
• Participants receiving anticoagulants are eligible upon reversal and stability within 24hrs after onset of ICH symptoms
• Age ≥ 18 years
• Able to receive first dose of test article ≤ 24h after onset of ICH symptoms
• NIHSS score ≥ 2 at randomization or Glasgow Coma Scale ≥ 5 at randomization
• Controlled blood pressure (systolic BP < 180 mm Hg) at randomization.
• Premorbid magnetic resonance spectroscopy (mRS) of 0-2
• Has adequate venous access
• No planned surgical intervention except EVD
• Written informed consent from the patient or legally authorized representative (LAR)

Exclusion Criteria:

• Unstable hematoma defined as > 6 mL increase as compared to previous CT volume taken at least 6 hours apart within 24 hrs after onset of ICH symptoms.
• Anticipated neurosurgical evacuation by open surgery or minimally invasive surgery with or without Alteplase (EVD allowed).
• Uncontrolled temp >38.5˚C at enrollment.
• Signs of intracranial infection or emergence of a systemic infection
• Is pregnant or lactating
• Signs of liver and kidney chronic disease (i.e. creatinine >2, bilirubin > 3, receiving dialysis)
• Non-reversible bleeding diathesis
• Used any chronic immunosuppressants or chronic anti-inflammatory drugs (excluding low-dose aspirin), by any route of administration within the past 7 days.
• Anticipated withdrawal of life-sustaining therapies within the first week after admission.
• In the opinion of the investigator, patient has any contraindication to the planned study assessments.
• In the opinion of the investigator, patient has a condition that could interfere with the proposed treatment or unacceptably increase the individual's risk by participating in the study.
• Concomitant enrollment in another acute interventional study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Daniel Hanley; (410) 361-7999; dhanley@jhmi.edu

Contact: Cailin Brady; (443) 927-3970; whisle1@jh.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05020535
• Other Study ID Numbers: IRB00295926; 1R01AG069930-01 ( U.S. NIH Grant/Contract ); R01AG069930 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Johns Hopkins University
• Original Responsible Party: Same as current
• Current Study Sponsor: Johns Hopkins University
• Original Study Sponsor: Same as current

Collaborators

• University of Kentucky
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Linda Van Eldik; University of Kentucky

• PRS Account: Johns Hopkins University
• Verification Date: December 2023