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Monoclonal Antibodies

Crizanlizumab for RVCL

Phase 2

Waitlist Available

Led By Andria Ford, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A diagnosis of RVCL with confirmation by genetic test

At least 25 years of age with imaging evidence of brain or eye disease at the time of study registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up year

Awards & highlights

Study Summary

This trial will test if a new drug, crizanlizumab, is safe and effective for treating retinal vasculopathy with cerebral leukoencephalopathy (RVCL), a rare and fatal condition that affects the microvasculature of the brain and eye. Up to 20 patients will be enrolled.

Who is the study for?

This trial is for adults over 25 with a rare, fatal genetic condition called RVCL confirmed by genetic testing. Participants must not be pregnant or breastfeeding and agree to use contraception. They should have normal blood counts, no recent infections, HIV, hepatitis B/C, or TB, and haven't taken certain medications recently.Check my eligibility

What is being tested?

The study is evaluating the effectiveness and safety of Crizanlizumab in treating RVCL. This Phase 2 trial aims to enroll up to 20 patients who suffer from this condition that severely affects brain and eye blood vessels.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include reactions typical of monoclonal antibody treatments such as infusion reactions, immune system changes, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with RVCL through a genetic test.

Select...

I am 25 or older and have brain or eye disease confirmed by imaging.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~year

This trial's timeline: 3 weeks for screening, Varies for treatment, and year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in lesion pattern on Fluid-Attenuated Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI) in RVCL patients.

Side effects data

From 2021 Phase 2 trial • 54 Patients • NCT04435184

Chest pain

Headache

Diarrhea

Dark and Infrequent Urination

Venous thrombembolism

Altered mental status

100%

80%

60%

40%

20%

Study treatment Arm

Crizanlizumab

Placebo Saline

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single Arm StudyExperimental Treatment1 Intervention

Single arm study: crizanlizumab will be supplied in single use vials containing 10 mL at a concentration of 10 mg/mL for administration by IV infusion. Each patient will receive one dose of crizanlizumab on day 1 of Week 1, day 1 of Week 3, day 1 of Week 7, and then day 1 of every 4-week cycle. On infusion day, the pharmacist or designated personnel will prepare individual doses of crizanlizumab for subjects on a milligram per kilogram basis (5 mg/kg) in a 100 mL infusion bag in accordance with the Pharmacy Manual. Crizanlizumab will be administered over 30 minutes by IV infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Crizanlizumab

2021

Completed Phase 2

~600

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,689 Total Patients Enrolled

Andria Ford, MDPrincipal InvestigatorWashington University School of Medicine

Media Library

Crizanlizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04611880 — Phase 2

Retinal Vasculopathy with Cerebral Leukoencephalopathy (RVCL) Research Study Groups: Single Arm Study

Retinal Vasculopathy with Cerebral Leukoencephalopathy (RVCL) Clinical Trial 2023: Crizanlizumab Highlights & Side Effects. Trial Name: NCT04611880 — Phase 2

Crizanlizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04611880 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other ongoing research projects involving this treatment option?

"The trials for this medication began at East Carolina University in 2017. To date, there are 2 completed studies and 10 active clinical trials. A large number of these ongoing studies are based in Philadelphia, Pennsylvania."

Answered by AI

Are patients still being recruited for this experiment?

"Unfortunately, this specific trial is not enrolling patients at the moment. The last update on clinicaltrials.gov was on January 27th, 2022 and it seems as if recruitment for this study concluded shortly after it began in 2021. There are plenty of other ongoing trials that might be a better fit - 130 to be exact."

Answered by AI

How many test subjects are enrolled in this experiment?

"This study is not recruiting at the moment. The listing was first posted on January 25th, 2021 and updated last on January 27th, 2022. Currently, there are 120 other clinical trials actively looking for patients with leukoencephalopathies and 10 trials for this particular treatment that are still searching for participants."

Answered by AI

How does the safety profile of this treatment compare to other similar treatments?

"While there is some evidence to support the safety of this Phase 2 treatment, there is currently no data indicating that it is effective."

Answered by AI

Are we enrolling elderly or younger individuals in this trial?

"As this study's inclusion criteria dictate, the age range for prospective patients is 25 to 75 years old."

Answered by AI

I am interested in taking part in this clinical research, what are the next steps?

"20 individuals aged 25 to 75 who have been diagnosed with leukoencephalopathies will be admitted into this clinical trial. Most importantly, potential patients must meet the following requirements: Females of childbearing potential (FCBP) must agree to not become pregnant while taking the study drug and for 3 months after discontinuation from study drug, and must agree to use adequate contraception including hormonal contraception, (i.e. birth control pills, etc), barrier method contraception (i.e. condoms), or abstinence during that time-frame, A diagnosis of RVCL with confirmation by genetic test, At least 25 years of age with imaging evidence of"

Answered by AI

Have medical researchers undertaken a study like this one before?

"Since 2017, this treatment has been under investigation through clinical trials. The first study was sponsored by Novartis Pharmaceuticals in 2017 and involved 57 patients. After the Phase 1 trial, the treatment received drug approval for Phase 2 testing. Currently, there are 10 active studies involving 144 cities and 36 countries."

Answered by AI

Recent research and studies

ImmunityJournal

Cytosolic Nuclease TREX1 Regulates Oligosaccharyltransferase Activity Independent of Nuclease Activity to Suppress Immune Activation

Hasan, Maroof, Charles S. Fermaintt, Ningguo Gao, Tomomi Sakai, Takuya Miyazaki, Sixin Jiang, Quan-Zhen Li, et al.. 2015. “Cytosolic Nuclease TREX1 Regulates Oligosaccharyltransferase Activity Independent of Nuclease Activity to Suppress Immune Activation”. Immunity. Elsevier BV. doi:10.1016/j.immuni.2015.07.022.

NeurologyJournal

Lesion Evolution and Neurodegeneration in RVCL-S

Ford, Andria L., Victoria W. Chin, Slim Fellah, Michael M. Binkley, Allie M. Bodin, Vamshi Balasetti, Yewande Taiwo, et al.. 2020. “Lesion Evolution and Neurodegeneration in RVCL-S”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/wnl.0000000000010659.

Journal of Clinical InvestigationJournal

Perspectives Series: Cell Adhesion in Vascular Biology. Role of PSGL-1 Binding to Selectins in Leukocyte Recruitment.

McEver, R P, and R D Cummings. 1997. “Perspectives Series: Cell Adhesion in Vascular Biology. Role of PSGL-1 Binding to Selectins in Leukocyte Recruitment.”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci119556.

Cell CycleJournal