At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Recombinant human tissue kallikrein (drug), Placebo for DM199 Solution for Injection (other)
- How long the study runs
- Study runs about 61 months (dates as stated)
- About the drug or intervention
- Recombinant human tissue kallikrein — drug: DM199 administered by a single intravenous (IV) dose followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21 · Placebo for DM199 Solution for Injection — other: Placebo administered by a single intravenous (IV) dose followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 90 Years
- Who
- All
- Number of participants
- 728
- Started
- 2021-11-07
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for acute stroke
- • Phase2/Phase3 - 728 participants
- • This is a Phase 2/3 study evaluating the safety and efficacy of DM199 (rinvecalinase alfa) in treating participants with moderate stroke severity, who present within 24 hours of Acute Ischemic Stroke (AIS) onset due to small and medium vessel occlusions
Who can take part?
- • Ages 18 Years to 90 Years
- • Diagnosed with acute stroke
Where?
- • Exeter - Royal Devon and Exeter Hospital
- • Newcastle upon Tyne - The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary (RVI)
- • Cambridge - Addenbrooke's Hospital
- • London - St George's Hospital
- • +8 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a Phase 2/3 study evaluating the safety and efficacy of DM199 (rinvecalinase alfa) in treating participants with moderate stroke severity, who present within 24 hours of Acute Ischemic Stroke (AIS) onset due to small and medium vessel occlusions. This study focuses on participants with limited treatment options. Participants who have or will receive mechanical thrombectomy (MT) are not eligible for participation. Additionally, participants who have received fibrinolytics are excluded unless they experience a persistent neurological deficit of moderate severity six or more hours after fibrinolytic treatment. Participants considered for this trial should not be denied the use of standard of care (SoC) AIS therapies, such as fibrinolytics or MT, when appropriate. The double-blinded study will be randomized and placebo-controlled at up to approximately 100 sites.
More detail
This is a Phase 2/3 Adaptive Design, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy2 Trial). Participants with AIS will be randomized 1:1 to DM199 or placebo. DM199 will be administered as a single intravenous (IV) dose (0.5 μg/kg; not to exceed 50 μg) followed by subcutaneous (SC) doses at 2 hours (+10 hours) of the IV dose completion and then 2 times per week up to Day 21. The duration of each individual's participation in the study will be approximately 90 days from the time of initial treatment to completion of all study activities. A formal interim analysis will be conducted after 200 participants complete their Day 90 assessment in Part A. The purposes of this interim analysis are to assess safety, allow early stopping of the study for futility, or continuing the study with a revised final sample up to a maximum of 728 participants.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 90 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Participant is between 18 and 90 years of age inclusive.
- ✓Participant weight is 40 kg to 166 kg inclusive.
- ✓Participant to be randomly assigned and treatment initiated within 24 hours of last known normal/AIS stroke onset.
- ✓Participant has NIHSS ≥5 and ≤15 at approximately the time of randomization. This criterion also applies to...
- ✓Participant meets all other inclusion and exclusion criteria, including repeat brain imaging to rule out hemorrhagic...
Who cannot take part
- ✗At screening, or with repeat imaging (see Inclusion 4 and 6), participant has imaging confirmed hemorrhage stroke.
- ✗Participant has image findings with causing symptoms large vessel occlusion at one or more of the following locations:...
- ✗Participant has large core of established infarction defined as ASPECTS 0-5.
- ✗Participant has or will receive MT for their current AIS.
- ✗Participant has suspected or confirmed extracranial arterial dissection.
See the full criteria
Where Is This Study? (12 UK sites)
Royal Devon and Exeter Hospital
Exeter EX25DW, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Royal Victoria Infirmary (RVI)
Newcastle upon Tyne NE1 4LP, United Kingdom
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
St George's Hospital
London SW17 0QT, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent ST4 6QG, United Kingdom
Victoria Hospital- NHS Fife- Scotland- UK
Kirkcaldy, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Barts Health NHS Trust The Royal London Hospital
London, United Kingdom
Charing Cross Hospital
London, United Kingdom
University College of London
London, United Kingdom
James Cook University Hospital
Middlesbrough, United Kingdom
Nottingham University Hospital
Nottingham, United Kingdom
How to Get in Touch
Shanique Smythe - Peterkin
Sponsor contactCONTACT
