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Itolizumab for Lupus (EQUALISE Trial)
EQUALISE Trial Summary
This trial will test a new drug for Lupus called itolizumab to see if it is safe and effective.
- Lupus Nephritis
- Lupus
EQUALISE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowEQUALISE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.EQUALISE Trial Design
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Who is running the clinical trial?
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- You have an infection that requires strong medication to treat.You have taken medications to suppress or change your immune system for lupus in the past or are currently taking them.You have been diagnosed with or currently have symptoms that meet the criteria for systemic lupus erythematosus (SLE) according to specific guidelines.You have been diagnosed with systemic lupus erythematosus (SLE).You have a history of high levels of antinuclear antibodies (ANA).You need initial treatment because you have newly diagnosed or recurring/active disease, or your current treatment hasn't worked well enough.Your blood works as it should.Your blood is working properly.Your most recent kidney function test result (eGFR) is above 40 mL/min/1.73m2.You show signs of immune system activity.If you are in the Type B group, your treatments for SLE must be stable or stopped before joining the study.You have kidney biopsy results showing certain types of lupus nephritis.Your urine has a lot of protein compared to creatinine.You have tested positive for hepatitis B, hepatitis C, or HIV.You currently have tuberculosis or a positive test for tuberculosis.
- Group 1: EQ001 Type A cohort
- Group 2: EQ001 for Type B cohort
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any remaining vacancies for enrollees in this trial?
"Affirmative, according to clinicaltrials.gov this medical experiment is still open for recruitment and was first shared on 10th October 2019. The latest update was made on April 19th 2022 and a total of 55 participants across 17 sites are needed in order to conduct the trial."
How many healthcare facilities are actively participating in this clinical experiment?
"At the moment, 17 medical centres are running this clinical trial. The sites can be located in Sun City, La Jolla and Dallas in addition to 14 other locations across America. It is advised that patients pick an establishment which is nearby their residential location to reduce travelling demands if they decide to take part."
How many test subjects have been recruited for this experiment?
"To proceed with the trial, a total of 55 eligible participants are needed. Biocon Limited will oversee this endeavor from multiple locations including AKDHC Medical Research Services in Sun City, Arizona and University of California San Diego Perlman Ambulatory Clinic in La Jolla, California."
Are there any other exploratory investigations involving Itolizumab [Bmab 600]?
"Itolizumab [Bmab 600] was initially investigated at Froedtert & the Medical College of Wisconsin's hospital in 2019. Subsequently, 2 studies have been fulfilled and there are currently two active trials being conducted; many sites for these experiments are located in Sun City, Arizona."
Does this trial accommodate individuals aged sixty or over?
"Eligibility criteria for this study necessitates that participants are under 75 years old and of legal age or older."
Who would meet the criteria to be an appropriate candidate for this medical experiment?
"This clinical trial requires that those who possess lupus nephritis, and are aged between 18-75 to be eligible. A total of 55 participants need to be enrolled in this study."
Does this clinical experiment represent a new approach in its field?
"Research involving the drug Itolizumab [Bmab 600] began in 2019, with a sponsored trial of 100 patients. After Phase 1 & 2 approval was granted due to these results, two active trials have been launched across 32 cities and 3 countries."
What safety risks have been identified with the use of Itolizumab [Bmab 600]?
"The safety of Itolizumab [Bmab 600] was rated a 1 on our scale due to its Phase 1 status, which indicates limited evidence supporting both efficacy and security."
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