Satralizumab in Aneurysmal Subarachnoid Hemorrhage

NCT05727657 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: OCR43615
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, satralizumab will be administered to see whether satralizumab is safe in patients with a burst brain aneurysm and if it may prevent strokes in patients with a burst brain aneurysm.

Conditions

Aneurysmal Subarachnoid Hemorrhage; Delayed Cerebral Ischemia

Outcome Measures

Primary Outcomes (5)

• Number of participants with elevation of liver transaminases

  Elevation of liver transaminase (ALT, AST) is defined as \>5x upper limit of normal.

  baseline up to 21 days

• Number of participants with neutropenia

  Neutropenia is defined as neutrophil count below 1 x 10\^9/L.

  baseline up to 21 days

• Number of participants with decreased platelet count

  Decreased platelet count is defined as a platelet count below the lower institutional limit of normal.

  baseline up to 21 days

• Frequency of observed and reported adverse events

  An adverse event will be defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational medicinal product (IMP) or other protocol-imposed intervention, regardless of attribution.

  baseline up to 90 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier

• Frequency of death

  All deaths that occur during the protocol-specified AE reporting period, regardless of attribution, will be recorded.

  baseline up to 90 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier

Study Arms (1)

Satralizumab

EXPERIMENTAL

Subjects will receive satralizumab 120mg subcutaneous Day 0 and Day 14 after enrollment.

Drug: Satralizumab

Interventions

Satralizumab DRUG

120mg subcutaneous Day 0 and Day 14

Satralizumab

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (aged ≥18 years) with Hunt Hess Grade 1-3, Fisher score 3 or 3 and 4, aneurysmal subarachnoid hemorrhage within 72 hours of symptom onset (ruptured aneurysm confirmed by CTA, MRA or DSA)
• Must have surgical or endovascular adequate occlusion of the ruptured aneurysm
• Must have external ventricular drain or lumbar drain.
• Female subjects of child-bearing potential must have negative pregnancy test
• Signed informed consent from subject or legally authorized representative
• Able and willing to comply with followup visits
• Women and males of childbearing potential must agree to appropriate methods of contraception during study participation

You may not qualify if:

• Evidence for vasospasm or DCI prior to study enrollment
• Hemodynamically unstable pre-enrollment
• Severe or unstable concomitant condition or disease (e.g., known significant neurological deficit, cancer, hematologic or coronary disease), or chronic condition (e.g., liver disease, kidney disease, or psychiatric disorder), that may increase the risk associated with study participation, or may interfere with the interpretation of study results
• Subjects who have received an investigational product or participated in another interventional clinical study within 30 days prior to enrollment.
• Known hypersensitivity to satralizumab and/or other biologics agents
• Serious infection defined as pneumonia, sepsis/septic shock, and neutropenic fever prior to enrollment
• Any previous treatment with IL-6 inhibitory therapy (e.g. tocilizumab), alemtuzumab, total body irradiation or bone marrow transplantation within 6 months prior to baseline.
• Any previous treatment with anti-CD20, anti-CD19, eculizumab, belimumab, interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate within 6 months prior to baseline.
• Any previous treatment with anti-CD4, cladribine or mitoxantrone within 2 years prior to baseline
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
• Women of childbearing potential must have a negative serum pregnancy test result prior to initiation of study drug.
• Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline.
• Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML).
• Evidence of serious uncontrolled concomitant diseases that may preclude patient participation, such as: other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency.
• Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.

Sponsors & Collaborators

• University of Florida: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Florida (UF) Health Shands Hospital

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

satralizumab

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian Hoh, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 14, 2023
• Study Start: June 1, 2024
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: March 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)