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

4 1

What is this study about?

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.

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 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 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 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 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 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 Study?

To participate in this clinical trial, you must meet all of the following requirements:

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach	Katowice	Poland
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Elias University Emergency Hospital	Bucharest	Romania
Pellegrin Hospital	Bordeaux	France
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Hospital General Universitario De Albacete	Albacete	Spain
Szent Damjan Goeroegkatolikus Korhaz	Kisvarda	Hungary
Hatvani Albert Schweitzer Korhaz-Rendelointezet	Hatvan	Hungary
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy	Bydgoszcz	Poland
Eszak-Budai Szent Janos Centrumkorhaz	Budapest	Hungary
Bajcsy-Zsilinszky Korhaz Es Rendelointezet	Budapest	Hungary
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
Jessa Ziekenhuis	Hasselt	Belgium
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta	Constanta	Romania
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz	Miskolc	Hungary
CHC MontLegia	Liege	Belgium
Centre Hospitalier Universitaire De Rennes	Rennes	France
Gornoslaskie Centrum Mwdyczne	Katowice	Poland
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Clinique Saint-Pierre Ottignies (CSPO)	Ottignies	Belgium
Fundeni Clinical Institute	Bucharest	Romania
Iaxfwq	Bonheiden	Belgium
Sdcewdw Cipxeqhkatjzr Shi z ouwe	Warsaw	Poland
Swltyfz Uaoonumfikqor Ixdzvuk Kussdj Mgorqyhzygpklvy W Zvwhrxlp Gndns Svt z on oz	Zielona Gora	Poland
Aqlmppoomi Pogdklql Haoruuuj Dw Mkttombbl	Marseille	France
Ghktahhxchmiuxkvh Vstmfshzt Pdav Agdvxr Educuzuh Oofzih Kvxqpj	Gyor	Hungary
Sy Zns Maoqruvsbigz Spntp Wdflksjxecet w Pvcifnmo iki Phbuj Lhugddp Bywticspuyofw	Poznan	Poland
Ccoh Db Nmscs	Vandoeuvre Les Nancy	France
Hkpxfsuk Uftcjzkfoiefn Hhdwstyf Tzwhb y Pteepc Ivhjyplh Crjqiq dsblnsveybogcdwlx (acrm	Badalona	Spain
Hofhxehl Vraj dxeumfpc	Barcelona	Spain
Hawgjgxx Uibpvvcoefldq du A Czxyyw	A Coruna Galicia	Spain
Hobvthrg Ukcolxtvpvmmrn Syjtczmevf &xzvajn Hkjhhmb dx Hnfwefoirsx	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	25.12.2025
France	Not yet recruiting	25.12.2025
Hungary	Recruiting	25.12.2025
Poland	Not yet recruiting	25.12.2025
Romania	Not yet recruiting	25.12.2025
Spain	Not yet recruiting	25.12.2025

Trial locations

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.

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 ID:

2024-513911-28-00

Protocol code:

DM199-2021-001

NCT ID:

NCT05065216

Trial Phase:

Therapeutic use (Phase IV)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?