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.
Eligibility criteria
Qualifiers
Participant is between 18 and 90 years of age inclusive.
Participant weight is 40 kg to 166 kg inclusive.
Participant to be randomized and treatment initiated within 24 hours of last known normal/AIS stroke onset.
The participant initially presents with an NIHSS score below 5 but clinically worsens, including cases of progressing stroke / stroke-in-evolution, resulting in a subsequent persistent NIHSS score of ≥5 and ≤15; and
Disqualifiers
Participant had a pre-morbid mRS score of 0 to 1 (mRS score prior to AIS) as stated by participant or participant's representative.
Participant's initial NIHSS score prior to fibrinolytics was ≤15; and
At least six hours after fibrinolytics, the participant has NIHSS score of ≥5 and ≤15 with a persistent deficit; and
The participant's NIHSS score showed less than a 4-point improvement, or worsened, after receiving fibrinolytics; and
Trial design
Treatments tested in this trial
- Recombinant human tissue kallikrein
- Placebo for DM199 Solution for Injection