beta
Trial Radar AI
Clinical Trial NCT07495722 (SUCCESS) for Acute Ischemic Stroke, Cerebral Infarction is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Safely Quenching Complement in Stroke Survivors (SUCCESS) Phase 1 20

Not yet recruiting
Clinical Trial NCT07495722 (SUCCESS) is designed to study Treatment for Acute Ischemic Stroke, Cerebral Infarction. This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on 1 April 2026 until the study accrues 20 participants. Led by Columbia University, this study is expected to complete by 1 August 2027. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
Brief Summary
This study will include adults (ages 18-80) who have had a stroke caused by a large blood clot blocking blood flow in the brain. All patients in the study must have already had a treatment called a thrombectomy, where doctors remove the clot to help blood flow return to the brain.

The goal of this study is to test the safety of a drug called EMPAVELI (pegcetacoplan). This drug is meant to lower swelling and inflamma...

Show More
Detailed Description
Acute ischemic stroke (AIS) remains the primary cause of disability worldwide. Advances in revascularization therapies such as pharmacologic thrombolysis and intra-arterial endovascular thrombectomy (EVT) have improved outcomes, yet >50% of patients remain functionally disabled at 90 days post-ictus onset despite high recanalization rates. One major reason for this limited recovery is the activation of thrombo-infla...Show More
Official Title

Safely Quenching Complement in Stroke Subjects: A Phase 1 Safety Trial

Conditions
Acute Ischemic StrokeCerebral Infarction
Other Study IDs
  • SUCCESS
  • SUCCESS-01
NCT ID Number
NCT07495722
Start Date (Actual)
2026-04
Last Update Posted
2026-03-27
Completion Date (Estimated)
2027-08
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Keywords
endovascular thrombectomy
large vessel occlusion
reperfusion injury
complement inhibition
C3 inhibition
pegcetacoplan
empaveli
neuroprotection
thromboinflammation
stroke recovery
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalEmpaveli (Pegcetacoplan) Treatment
Participants will receive pegcetacoplan (Empaveli) administered as three subcutaneous doses of 1,080 mg given within 0-3 hours following endovascular thrombectomy, and at 24 and 48 hours after the initial dose. This is a single-arm, open-label study designed to evaluate the safety and tolerability of complement C3 inhibition in adults with acute ischemic stroke due to anterior circulation large vessel occlusion.
Pegcetacoplan Injection [Empaveli]
In this study, participants will receive three 1,080 mg doses delivered within 0-3 hours following endovascular thrombectomy, and at 24 and 48 hours after the initial dose. Pegcetacoplan is FDA-approved for the treatment of paroxysmal nocturnal hemoglobinuria and is being evaluated in this study for its safety and tolerability in acute ischemic stroke patients following reperfusion.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Incidence of Treatment-Emergent Adverse Events
To evaluate the safety and tolerability of pegcetacoplan (Empaveli) in adult patients with acute ischemic stroke following endovascular thrombectomy, as measured by the incidence, type, and severity of treatment-emergent adverse events (AEs) and serious adverse events (SAEs).
Through 90 days post-treatment
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Neurological Functional Outcome
Functional outcome as measured by the modified Rankin Scale (mRS). The scale is from 0-6, where 0 indicates no symptoms at all and 6 indicates Death. Therefore, higher scores represent worse outcomes.
Through 90 days post-treatment
Neurological Deficit Severity
Change in National Institutes of Health Stroke Scale (NIHSS) score from baseline. The scale is graded from 0-42, with a score of 0 indicating no stroke while a maximum score of 42 indicates severe stroke. A higher score represents greater stroke severity.
Baseline through 90 days
Biomarker Response
Changes in complement and neuroinjury biomarkers (e.g., C3, C3b, S100b, GFAP)
Baseline through 90 days
Maximum Plasma Concentration [Cmax] of Pegcetacoplan
Maximum observed plasma concentration (Cmax) of pegcetacoplan following administration.
Through 72 hours
Time to Maximum Plasma Concentration [Tmax] of Pegcetacoplan
Time to reach maximum observed plasma concentration (Tmax) of pegcetacoplan.
Through 72 hours.
Infectious Complications
Incidence of infections including sepsis, pneumonia, and urinary tract infections
During hospitalization and through 90 days
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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
Columbia University logoColumbia University808 active studies to explore
Study Responsible Party
E. Sander Connolly, Principal Investigator, Chair and Professor, Department of Neurological Surgery, Columbia University
Study Central Contact
Contact: Angela Velazquez, 6465151909, [email protected]
Contact: Eleonora F Spinazzi, MD, [email protected]
No location data.