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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

In context

Cerebral Hemorrhage

457 studies on the registry are indexed under Cerebral Hemorrhage; 172 are open to participants now.

This study's planned enrollment of 120 is above the median of 100 across 269 interventional studies indexed under Cerebral Hemorrhage.

Browse Cerebral Hemorrhage studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.

Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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, > 3, receiving dialysis)
  • Non-reversible bleeding diathesis
  • Used any chronic 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 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

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)

06

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

07

Study locations

11 sites
08

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2022 (actual). Primary completion is estimated for Nov 2026, 49 months after the start.

Of 24 phase 2 interventional studies under Cerebral Hemorrhage, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 62. This study's planned 49 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2021
First posted
Aug 25, 2021
StartActual
Oct 10, 2022
Primary completionEst.
Nov 30, 2026
CompletionEst.
Oct 1, 2027
Last update
Apr 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05020535
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 ↗

Not currently enrolling

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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