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Active, not recruitingNCT05020535BEACHUpdated Apr 2, 2026

Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)

A Phase 2 interventional study of MW189 and Saline in Intracerebral Hemorrhage, sponsored by Johns Hopkins University. Active, not recruiting at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-02.

Sponsored by Johns Hopkins University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Intracerebral Hemorrhage

Keywords

  • Intracerebral hemorrhage
  • MW01-6-189WH
  • MW189
  • Radiographic perihematomal edema
  • Neuroinflammation
  • Cerebral edema
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

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)

    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)

    Other: Saline

Interventions

  • DrugMW189

    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)

  • OtherSaline

    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)

05

What researchers measure

Primary outcomes

  1. Difference in the proportion of all cause-morality between arms

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

    Time frame: 7 days post-randomization

06

Study locations

11 sites
  • University of Alabama Birmingham
    Birmingham, Alabama 35294, United States
  • Stanford University
    Palo Alto, California 94304, United States
  • Yale New Haven Hospital
    New Haven, Connecticut 06511, United States
  • Cleveland Clinic Florida
    Stuart, Florida 34994, United States
  • University of Kentucky
    Lexington, Kentucky 40536, United States
  • Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
  • University of New Mexico
    Albuquerque, New Mexico 87131, United States
  • New York University Grossman School of Medicine
    Brooklyn, New York 11220, United States
  • University of Cincinnati
    Cincinnati, Ohio 45219, United States
  • University of Texas Houston
    Houston, Texas 77030, United States
  • University of Texas San Antonio
    San Antonio, Texas 78229, United States
07

References and documents

Publications

  • Sorensen G, Remillard W, Schlechter M, Kampp M, Whisler Brady C, Kildahl K, Mould A, Ziai W, Lane K, Van Eldik LJ, Distasio A, Lu J, Sansing LH, Hanley DF, Magid-Bernstein J. Operationalizing a complex acute clinical trial: Lessons from the BEACH study. J Clin Transl Sci. 2025 Sep 12;9(1):e215. doi: 10.1017/cts.2025.10152. eCollection 2025. PubMed 41040632 ↗
  • Sorensen G, Remillard W, Schlechter M, Kampp M, Sansing LH, Brady CW, Kidahl K, Ziai W, Van Eldik L, Distasio A, Lu J, Magid-Bernstein J, Hanley D. Operationalizing a complex acute clinical trial: Lessons from the BEACH study. medRxiv [Preprint]. 2025 Mar 31:2025.03.28.25324776. doi: 10.1101/2025.03.28.25324776. PubMed 40236420 ↗
  • Avadhani R, Ziai WC, Thompson RE, Mould WA, Lane K, Nanni A, Iacobelli M, Sharrock MF, Sansing LH, Van Eldik LJ, Hanley DF; BEACH trial consortium. Clinical Trial Protocol for BEACH: A Phase 2a Study of MW189 in Patients with Acute Nontraumatic Intracerebral Hemorrhage. Neurocrit Care. 2024 Apr;40(2):807-815. doi: 10.1007/s12028-023-01867-2. Epub 2023 Nov 2. PubMed 37919545 ↗
08

Registry details

Key details

Study ID
NCT05020535
Lead sponsor
Johns Hopkins University
Collaborators
University of Kentucky, National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Aug 25, 2021
Start date
Oct 10, 2022
Primary completion
Nov 30, 2026 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Apr 2, 2026

Study contacts

Linda Van Eldik
principal investigator · University of Kentucky

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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