Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH)

Johns Hopkins University

Status and phase: Enrolling; Phase 2

Conditions: Intracerebral Hemorrhage

Treatments: Other: Saline; Drug: MW189

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05020535

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

IRB00295926

R01AG069930 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

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)

Treatment:

Drug: MW189

Control

Placebo Comparator group

Description:

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)

Treatment:

Other: Saline