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New treatment option for Aneurysmal Subarachnoid Hemorrhage
Official title Tocilizumab-aazg for Hemorrhage: Reduction of Ischemic Vascular Events
ClinicalTrials.gov ID: NCT06863480
What this study is testing
What is tocilizumab-aazg (TYENNE)?
tocilizumab-aazg (TYENNE) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for aneurysmal subarachnoid hemorrhage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join 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...
- Must have external ventricular drain or lumbar drain, or plan to place an external ventricular drain or lumbar drain.
- Female people 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
You likely can't join 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...
- people who have received an investigational product or participated in another treatment 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
See the full eligibility criteria
Who can join
- 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 people 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...
- 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...
What rules you out
- 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...
- people who have received an investigational product or participated in another treatment 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...
- Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline.
- History of diverticulitis that, in the principal investigator's opinion, may lead to increased risk of complications such as lower gastrointestinal perforation.
- Evidence of active or untreated latent tuberculosis (TB; excluding patients receiving chemoprophylaxis for latent TB infection).
- Evidence of active interstitial lung disease
- Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline and throughout the duration of the study.
- History of malignancy within the last 5 years, including solid tumors, hematologic malignancies and in situ carcinoma (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri...
- Laboratory exclusion criteria (at screening):
- White blood cells (WBC) \<3.0 x103/μL
- Absolute neutrophil count (ANC) \<2.0 x103/μL
- Absolute lymphocyte count \<0.5 x103/μL
- Platelet count \<100 x 103/μL
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times the upper limit of normal (ULN).
- Patient with known medical history at screening listed for the following must be excluded from this trial:
- Evidence of chronic active hepatitis B (HBV)
- Evidence of chronic active hepatitis C (HCV)
- Positive for hepatitis C virus (HCV) antigen
- Positive for hepatitis B surface antigen (HBsAg)
- Known HIV infection.
- Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
- Poor peripheral venous access
- Serious infection requiring oral or IV antibiotics prior to screening
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
- History or presence of an abnormal ECG that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree atrioventricular heart block, or evidence of...
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.