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Intracerebral HemorrhagePhase 2BEACHNCT05020535

Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)

A Phase 2 study testing MW189 and Saline in people with Intracerebral Hemorrhage, run by Johns Hopkins University at 11 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracerebral Hemorrhage
What is being tested?
MW189 and Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
11 sitesUnited States
Study dates
10 Oct 2022to 1 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • 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
Show all 11Show fewer
  • 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)

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • University of Alabama Birmingham

    Birmingham, Alabama, 35294

  • New York University Grossman School of Medicine

    Brooklyn, New York, 11220

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • University of Texas Houston

    Houston, Texas, 77030

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Yale New Haven Hospital

    New Haven, Connecticut, 06511

  • Stanford University

    Palo Alto, California, 94304

  • University of Texas San Antonio

    San Antonio, Texas, 78229

  • Cleveland Clinic Florida

    Stuart, Florida, 34994

Other trials in United States

About this study

Official title: 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).

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.

Being tested
MW189, Saline
Keywords
Intracerebral hemorrhage, MW01-6-189WH, MW189, Radiographic perihematomal edema, Neuroinflammation, Cerebral edema
Medical subject headings
Cerebral Hemorrhage, Neuroinflammatory Diseases, Brain Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MW189Drug

    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)

  • SalineOther

    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 groups in NCT05020535
Study groupRoleWhat they receive
ExperimentalExperimentalMW189 (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)
Receives: Drug: MW189
ControlPlacebo comparatorAdministration 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)
Receives: Other: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 7 days post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2021
  2. Study start10 Oct 2022
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel 1:1
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05020535
Sponsor's protocol ID
IRB00295926
Other IDs
1R01AG069930-01, R01AG069930
Acronym
BEACH
Status last verified
Apr 2026
First submitted
19 Aug 2021
Last updated
2 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MW189 and Saline in people with Intracerebral Hemorrhage, run by Johns Hopkins University at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in the proportion of all cause-morality between arms (time frame: 7 days post-randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05020535, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.

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