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

April 1, 2026 updated by: Johns Hopkins University

Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) Phase 2a Trial

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama Birmingham
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale New Haven Hospital
    • Florida
      • Stuart, Florida, United States, 34994
        • Cleveland Clinic Florida
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University Of Kentucky
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
    • New York
      • Brooklyn, New York, United States, 11220
        • New York University Grossman School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Houston
      • San Antonio, Texas, United States, 78229
        • University of Texas San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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)
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)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Aging (NIA)
University of Kentucky

Investigators

  • Principal Investigator: Linda Van Eldik, University Of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2022

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

August 19, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00295926
  • 1R01AG069930-01 (U.S. NIH Grant/Contract)
  • R01AG069930 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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