Tocilizumab-aazg for Hemorrhage: Reduction of Ischemic Vascular Events

NCT06863480 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB202201531
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, tocilizumab-aazg (TYENNE) will be administered to see whether tocilizumab-aazg 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.

  up to 21 days

• Number of participants with neutropenia

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

  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.

  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)

tocilizumab-aazg (TYENNE)

EXPERIMENTAL

Participants will receive tocilizumab-aazg 6mg/kg IV infusion drip on Day 0 following subarachnoid hemorrhage and enrollment in the trial.

Drug: tocilizumab-aazg (TYENNE)

Interventions

tocilizumab-aazg (TYENNE) DRUG

A single dose of tocilizumab-aazg (TYENNE) will be administered by intravenous drip.

tocilizumab-aazg (TYENNE)

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 24 hours of symptom onset (ruptured aneurysm confirmed by CTA, MRA or DSA)
• Must have external ventricular drain or lumbar drain, or plan to place an 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
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined below:
• Women must remain abstinent or use non-hormonal contraceptive methods with a failure rate of 1% per year during the treatment period and for 2 months after the final dose of TYENNE. Women must refrain from donating or storing eggs during the same time period. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.
• The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. If required per local guidelines or regulations, locally recognized acceptable methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.
• The following are examples of adequate non-hormonal contraceptive methods: bilateral tubal ligation; male sterilization; copper intrauterine devices; male or female condom with or without spermicide; and cap, diaphragm, or sponge with spermicide.
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below: With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 2 months after the dose of TYENNE to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
• The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of preventing drug exposure. If required per local guidelines or regulations, information about the reliability of abstinence will be described in the local Informed Consent Form.

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 or severe allergic reaction to tocilizumab and/or other biologics agents (i.e. shock, anaphylactic reactions)
• Serious infection defined as pneumonia, sepsis/septic shock, and neutropenic fever prior to enrollment
• Any previous treatment with IL-6 inhibitory therapy (e.g. satralizumab), alemtuzumab, etc.
• 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 2 months after TYENNE administration
• 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 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

Study Sites (1)

University of Florida Health (UF Health)

Gainesville, Florida, 32608, United States

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage

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

Central Study Contacts

Brian Hoh, MD

CONTACT

352-273-9000; brian.hoh@neurosurgery.ufl.edu

Study Design

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

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: March 2, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-01

Locations

US (1)