What is infliximab studying for dolichoectactic vertebrobasilar aneurysms?

Infliximab is being studied as a treatment for rare and large DVB aneurysms that are difficult to treat with surgery. This study aims to see if infliximab can reduce aneurysm size and improve blood flow characteristics. The University of California, San Francisco is leading this research.

Who may be eligible for this aneurysm clinical trial?

Adults 18 years or older with vertebral or basilar artery DVB aneurysms not suitable for surgery may be eligible. This trial is open to all genders and excludes those who have used anti-TNF or biologic drugs recently or have certain infections or medical conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this aneurysm clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID02638701

Infliximab Treatment for Dolichoectatic Vertebrobasilar Artery Aneurysms Phase 1 and 2 Study of Intravenous Therapy Over 12 Months

Led by University of California, San Francisco · Updated on 2026-06-11

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Dolichoectatic vertebrobasilar DVB aneurysms are rare, large, and fusiform brain aneurysms that pose serious risks such as subarachnoid hemorrhage, ischemic stroke, and brainstem compression. Surgical or endovascular treatments are usually not feasible due to their size and shape, leading to high mortality rates and neurological deficits in affected patients. Researchers are exploring new medical therapies because existing invasive methods are often fatal or ineffective for this condition. This study evaluates infliximab, a tumor necrosis factor alpha TNFb1 inhibitor, as a potential treatment for DVB aneurysms. Participants will receive infliximab intravenously at 3 mgkg at weeks 0, 3, and 7, then every 8 weeks for a total of 12 months. MRI scans will be performed at baseline, 12 months, and 24 months to monitor changes in aneurysm size and characteristics. Participants will undergo regular assessments including MRI imaging to measure aneurysm volume and blood flow dynamics. Researchers will evaluate the reduction in aneurysm volume after 12 months as the primary outcome, along with secondary measures such as flow velocity, shear stress, oscillatory index, and aneurysm wall enhancement. The trial aims to monitor effectiveness and safety over a long-term period ending in 2028, with careful screening to ensure participant suitability.

CONDITIONS

Brief Title

Infliximab Therapy for Dolichoectactic Vertebrobasilar Aneurysms

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Infliximab therapy (trial arm)	Current non-interventional medical management (antiplatelet therapy context)
What is it?	Infliximab is a biologic medication targeting tumor necrosis factor-alpha, being studied as an experimental therapy for vertebrobasilar dolichoectactic aneurysms in patients unsuitable for microsurgical or endovascular treatment.	Best current medical management typically includes antiplatelet therapy, which aims to reduce risks of thromboembolism and is recommended for patients with vertebrobasilar dolichoectactic aneurysms not suitable for intervention.
Role in trial	Serves as the sole investigational intervention in a single-arm early-phase therapeutic study for patients with vertebrobasilar dolichoectactic aneurysms.	Represents current practice for managing patients who cannot have surgical or endovascular treatment for these aneurysms.
Primary use	Studied for potential to reduce aneurysm volume and assess changes in aneurysm-related computational and imaging markers over 12 months.	Aims to manage symptoms and minimize risk of thromboembolic events in patients with aneurysms, though does not alter aneurysm size.
How is it given or performed?	Infliximab is given as an infusion according to study protocol, with regular follow-up imaging and laboratory monitoring over 12 months.	Antiplatelet therapy (such as aspirin or similar agents) is prescribed orally as routine outpatient medication with ongoing clinical monitoring.
Evidence status	Ongoing clinical investigation; published outcome evidence for infliximab in treating vertebrobasilar dolichoectactic aneurysms is not yet established.	Antiplatelet therapy is supported by published evidence for cardiovascular protection, but limited data exists regarding direct effect on aneurysm progression.
Important limitations	Small study size, single-arm early-phase design, unknown risk/benefit for infliximab in this population, and no control group to directly measure comparative effectiveness.	Current medical management is not curative; no established therapy directly prevents aneurysm growth or complications, and evidence for antiplatelet effect is limited.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Vertebral and/or basilar artery dolichoectactic aneurysm not amenable to microsurgical or endovascular treatment.
Age greater than 18 years at time of first study drug administration.

You will not qualify if you...

Use of an anti-TNF or other biologic medication within the previous 12 months.
Neutropenia with absolute neutrophil count less than 1,500/microliter.
Thrombocytopenia with platelets less than 100,000.
Anemia with hemoglobin less than 8 g/dL.
Liver function tests (AST or ALT) greater than or equal to 3 times the upper limit of normal.
Renal insufficiency with serum creatinine greater than 2.0 mg/dL.
Positive purified protein derivative (PPD) test of more than 5 mm induration without treatment documentation.
History of positive PPD, QuantiFERON-TB Gold test, or chest x-ray indicating prior TB without treatment documentation.
Presence of open leg ulcers.
Chronic or persistent infections including HIV, untreated hepatitis B, listeriosis, TB, or other opportunistic infections.
Active or severe infections requiring hospitalization or intravenous antibiotics, antivirals, or antifungals within 30 days prior.
Receipt of a live vaccine within 4 weeks prior to randomization.
History of malignancy within the past 5 years except treated localized cervical carcinoma in situ or adequately treated non-metastatic skin carcinoma.
Any medical condition that would put the subject at risk as judged by the investigator.
Women of childbearing potential who are sexually active and do not agree to use contraception during the study.
Pregnant or breastfeeding women.
Use of any investigational agent within 4 weeks or 5 half-lives prior to randomization.
History of drug or alcohol abuse within 6 months prior to randomization.
Known allergy or hypersensitivity to any study products.
Any psychiatric disorder preventing informed consent.
Inability or unwillingness to follow the protocol.
Unable to undergo MR imaging.

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 12 months

Participants receive infliximab intravenously at weeks 0, 3, and 7, then every 8 weeks for a total of 12 months. MRI scans are performed at baseline, 12 months, and 24 months to monitor aneurysm changes.

Dosing at weeks 0, 3, 7, then every 8 weeks; MRI at 0, 12, and 24 months