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A Study to Test if Rinvecalinase Alfa is Safe and Works for Treating Acute Ischemic Stroke in Patients with Moderate Stroke Severity

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at acute ischemic stroke, which is a condition where blood flow to part of the brain is suddenly blocked, causing brain cells to be damaged or die. The study will test a treatment called DM199, also known as rinvecalinase alfa, which is given as an injection. Some participants will receive DM199 while others will receive placebo. The study is designed to find out if DM199 is safe and if it works better than placebo in helping people recover from this type of stroke. This research focuses on people who have moderate stroke severity and who have limited treatment options, particularly those who cannot receive or have not benefited from other common stroke treatments.

Participants in this study will be adults between 18 and 90 years old who have experienced a stroke within the past 24 hours. The treatment will be given over a period of 21 days. During the study, participants will have various health checks including physical examinations, blood tests, heart monitoring with an electrocardiogram, and measurements of vital signs such as blood pressure, heart rate, breathing rate, and body temperature. These checks will happen at different times during the study, including on days 1, 4, 21, and 90.

The main goal of the study is to measure how well participants recover from their stroke by day 90, which will be assessed using a scale called the modified Rankin Score that measures how well people can function in their daily activities. The study will also carefully track any side effects or unwanted reactions that participants may experience, including reactions at the injection site. Additional measurements will look at how independent participants are in performing daily activities, their neurological recovery, and whether they experience another stroke during the 90-day study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Your treatment with the study medication will begin within 24 hours from the time you were last known to be normal or from when your stroke symptoms started.

    You will receive either DM199 (rinvecalinase alfa) or a placebo through an injection. A placebo is an inactive substance that looks identical to the study medication but contains no active ingredient. Neither you nor your doctor will know which one you are receiving.

    The study medication will be administered through parenteral use, which means it will be given by injection rather than taken by mouth.

  2. Step 2

    Day 1 assessments

    On the first day of treatment, your vital signs will be measured. This includes your heart rate, blood pressure, breathing rate, and body temperature. These measurements will be compared to your initial values.

    You will have a 12-lead electrocardiogram, which is a test that records the electrical activity of your heart. This will be compared to your baseline recording.

  3. Step 3

    Day 4 assessments

    Your vital signs will be measured again and compared to your initial values.

    Blood samples will be taken to check your hematology (blood cell counts) and chemistry parameters (various substances in your blood). These results will be compared to your baseline blood tests.

  4. Step 4

    Day 21 assessments

    You will have a physical examination, and the findings will be compared to your initial examination.

    Your vital signs will be measured and compared to your initial values.

    Blood samples will be taken to check your hematology and chemistry parameters, with results compared to your baseline tests.

  5. Step 5

    Day 90 final assessments

    You will have a physical examination, with findings compared to your initial examination.

    Your vital signs will be measured and compared to your initial values.

    Blood samples will be taken to check your hematology and chemistry parameters, with results compared to your baseline tests.

    You will have a 12-lead electrocardiogram, which will be compared to your baseline recording.

    Your stroke recovery will be assessed using the modified Rankin Score, which measures your level of disability or dependence in daily activities. The score ranges from 0 (no symptoms) to 6 (death).

    Your neurological outcome will be evaluated using the NIHSS (a stroke severity scale ranging from 0 to 42, where lower scores indicate less severe symptoms).

    Your ability to perform daily activities will be assessed using the Barthel Index, which measures your functional independence. This score ranges from 0 to 100, with higher scores indicating greater independence.

  6. Step 6

    Ongoing safety monitoring

    Throughout the study, any adverse events (unwanted or harmful reactions) and serious adverse events will be recorded and evaluated for their severity and whether they are related to the study medication.

    Any reactions at the injection site will be monitored and recorded.

    Specific events of particular interest to the study will be carefully tracked.

    If you experience a new stroke during the 90-day period, this will be documented and assessed through neurological examination and, if available, imaging studies.

Who can join the trial?

8 criteria

  • You must be between 18 and 90 years old.
  • Your body weight must be between 40 kg and 166 kg (approximately 88 to 366 pounds).
  • You must be able to start receiving the study treatment within 24 hours from when you were last known to be normal or when your stroke symptoms began.
  • Your stroke severity score must be between 5 and 15 on a scale called NIHSS (a test doctors use to measure how severe a stroke is, with higher numbers meaning more severe symptoms) at the time you join the study. This also applies if you first had a score below 5 but your condition got worse and you now have a persistent score between 5 and 15, as long as a repeat brain scan shows no bleeding in your brain.
  • Before this stroke, you must have been able to live independently or with minimal help, measured by a score of 0 to 1 on the mRS scale (a scale that measures how much a stroke affects your daily activities), as confirmed by you or someone who knows you well.
  • If you received fibrinolytic treatment (a clot-busting medication) within 4.5 hours of your stroke and at least 6 hours have passed since completing that treatment, you may be eligible if all of the following apply: your initial stroke severity score before receiving the clot-busting medication was 15 or below; at least six hours after the treatment, your stroke severity score is between 5 and 15 with symptoms that continue; your stroke severity score improved by less than 4 points or got worse after the treatment; and a repeat brain scan shows no significant bleeding (small amounts of bleeding called HI1 and HI2 are acceptable, but larger bleeding called PH1 or PH2, or any bleeding that makes your symptoms worse, would exclude you).
  • You or your legally authorized representative (someone legally allowed to make medical decisions for you) must be able to provide informed consent (agreement to participate after understanding the study).
  • You must be willing and able to follow the study requirements, as determined by the study doctor.

Who cannot join the trial?

6 criteria

  • You have received or will receive mechanical thrombectomy, which is a procedure to remove a blood clot from a blood vessel in the brain
  • You have received fibrinolytics, which are clot-dissolving medications, unless it has been at least 6 hours since treatment and you still have moderate stroke symptoms
  • Your stroke was caused by a large blood vessel blockage, as this study only includes strokes from small and medium vessel blockages
  • It has been more than 24 hours since your stroke symptoms started or since you were last known to be normal
  • Your stroke symptoms are not of moderate severity, as this study is specifically for patients with moderate stroke severity
  • You would normally qualify for standard stroke treatments like clot-dissolving medications or mechanical thrombectomy, as you should not be denied these treatments to participate in this study
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Investigated drugs

  • DM199

    (also known as rinvecalinase alfa) is an experimental medication being tested to treat stroke caused by blocked blood vessels in the brain. This medication is being studied in patients who have a moderate stroke and who have limited treatment options available to them.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare against the experimental medication to help determine if the medication is truly effective.

What is already known about the treatment

DM199 (rinvecalinase alfa) – DM199 is an experimental medication currently being tested in clinical trials for treating acute ischemic stroke, which occurs when blood flow to the brain is blocked. It is administered to patients with moderate stroke severity who present within 24 hours of stroke onset and have limited treatment options, specifically those with small and medium vessel blockages who are not candidates for mechanical clot removal or certain other standard treatments. The medication works at a molecular level through a specialized mechanism involving enzyme activity that aims to improve outcomes after stroke by potentially enhancing blood flow and protecting brain tissue. This drug is classified as a biological therapeutic agent and is being evaluated in a Phase 2/3 clinical trial to determine both its safety and effectiveness in helping stroke patients recover.

Investigated diseases

Acute Ischemic Stroke – Acute ischemic stroke occurs when blood flow to a part of the brain is suddenly blocked, usually by a blood clot in a vessel. This blockage prevents oxygen and nutrients from reaching brain tissue, causing brain cells in the affected area to begin dying within minutes. The condition can result from clots forming in small, medium, or large blood vessels that supply the brain. Common signs include sudden weakness or numbness on one side of the body, difficulty speaking or understanding speech, vision problems, dizziness, and loss of balance. The severity of symptoms depends on which part of the brain is affected and how much tissue is damaged. Without restoration of blood flow, the affected brain area continues to deteriorate, leading to varying degrees of disability depending on the location and extent of the damage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-513911-28-00Protocol codeDM199-2021-001Estimated enrolment728 patientsSponsorDiamedica Therapeutics Inc.

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