Could a new drug help stroke patients recover better?
NCT ID NCT07495722
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tests the safety of a drug called pegcetacoplan (Empaveli) in 20 adults who have had a stroke from a large clot and already had a procedure to remove it. The drug aims to reduce swelling and inflammation that can occur when blood flow returns. Participants receive three doses and are followed for 90 days to check for side effects and recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pegcetacoplan (Empaveli)
- What this could lead to
- If safe, this could point toward a treatment that reduces brain swelling and improves recovery after a stroke.
- What could go wrong
- This is a very early Phase 1 safety trial with only 20 people. It is not designed to prove the drug works, and side effects or lack of benefit are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults (18-80 years old) * Diagnosis of AIS due to anterior circulation (Intracranial ICA, M1 MCA) LVO with evidence of complete/near-complete revascularization following EVT (mTICI ≥2b). * Enrollment within 24 hours of reperfusion, with reperfusion occurring within 24 hours of ictus onset. * Body weight ≥ 50 kg. * Absolute reticulocyte count \>1.0 x ULN * Platelet count of \>50,000/mm³ * Absolute neutrophil count (ANC) ≥ 1500/mm³ at * Vaccination against Neisseria meningitidis types A, C, W, Y and B, Streptococcus pneumoniae and Haemophilus influenzae Type B (Hib) either within 2 years prior to Day1 dosing, or within 14 days after EMPAVELI. Unless documented evidence exists, that subjects are non-responders to vaccination as evidenced by titers or display titer levels within acceptable local limits * Women of child-bearing potential (WOCBP) must have a negative pregnancy test and must agree to use protocol defined methods of contraception for the duration of the study and 90 days after study drug administration. * Males must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study and 90 days after study drug administration. * English/Spanish-speaking patients or legally authorized representatives (LARs). * Signed informed consent from the patient or LAR. Exclusion Criteria: * Pregnant or lactating female * Suspected pregnancy. * Renal insufficiency (GFR\<30mL/minute OR creatinine \>2 mg/dL OR need for renal replacement therapy (RRT) at time of admission). * Platelet count \< 50,000/mm³ * Absolute neutrophil count \<1500/mm³ * Baseline mRS \>2 * Presence of concomitant serious illness that would confound study, including but not limited to serious psychiatric or autoimmune disease, sepsis, or trauma. * Immunocompromised status (e.g., subjects with Human Immunodeficiency Virus \[HIV\] infection, neutropenia, complement deficiency, etc.) * Autoimmune disorder (Sjogren's Disease, Psoriasis, hediak-Higashi Syndrome) * Presence of any intracranial bleed (ICH, SAH, SDH, hemorrhagic lesion). * Active hepatic failure as defined by AST \>160 units/L and/or ALT \>180 units/L, or total bilirubin levels greater than four times normal levels (\>4.8mg/dL). * Continued use of digoxin or amlodipine (as recommended by the manufacturer due to CYP3A inhibition). * Patients with DNR orders. * Known infection at the time of admission (elevated WBC with identified infection source) * Evidence of blood dyscrasia. * Episode of fever \> 38.5 degrees Celsius during admission and prior to enrollment. * History of any clinically significant disease or disorder which, in the opinion of the Investigator, could have either put the subject at risk because of participation in the study, or interfered with interpretation of the subject's study results
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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