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Fenebrutinib for Multiple Sclerosis (FENopta Trial)
FENopta Trial Summary
This trial will evaluate the effect of fenebrutinib on brain MRI in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated.
FENopta Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFENopta Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.FENopta Trial Design
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Who is running the clinical trial?
Media Library
- My RMS diagnosis follows the 2017 McDonald Criteria.I haven't taken any corticosteroid medicines in the last 4 weeks.You are not able to have an MRI scan.I do not have any major heart, lung, kidney, liver, hormone, metabolism, or stomach conditions.I have not received a live vaccine in the last 6 weeks.I do not have any neurological disorders that could affect my MS diagnosis or study participation.I need long-term steroids or immunosuppressants for another condition.I have had cancer, including blood or solid tumors, in the last 10 years.My illness started over 10 years ago and I have little to no disability.I have a history of or currently have an immune system disorder not caused by medications, including HIV.I do not have any active infections, including Hepatitis B or C, TB, or PML.I have been diagnosed with PPMS or non-active SPMS.I recently took medication that affects my immune system without a break.I am a man and agree to not have unprotected sex or donate sperm.My disability level allows me to walk without aid or rest for 200 meters.You have had problems with drinking too much alcohol or using drugs in the past year.
- Group 1: Fenebrutinib
- Group 2: Placebo
- 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
How many individuals are participating in this empirical research?
"Indeed, clinicaltrials.gov shows the trial is still recruiting participants since it was first published on March 1st of 2022 and last updated in November 10th of 2022. A total of 102 patients are being accepted across two sites."
Could I potentially join the cohort of this clinical study?
"This clinical trial is open to 102 individuals aged between 18 and 55 that have been diagnosed with multiple sclerosis. Furthermore, they must meet the revised McDonald Criteria for RMS as well as having a EDSS score of 0-5.5 at screening. For female patients capable of bearing children, abstinence or contraception will be mandated whilst male participants are also required to abstain from sexual intercourse or use birth control measures in addition to not donating sperm."
Does the Food and Drug Administration have a stamp of approval on fenebrutinib?
"Supported by a Phase 2 trial, the safety of fenebrutinib is estimated to be moderate at a score of 2. Currently, no data exists that proves its efficacy."
Is the enrollment process still ongoing for this research endeavor?
"Clinicaltrials.gov affirms that this medical investigation is actively recruiting subjects; the study was first advertised on March 1st 2022 and recently revised on November 10th 2022."
Is this experiment open to seniors who are at least 70 years of age?
"This clinical trial has an age-based eligibility threshold, wherein individuals above 18 years old and below 55 can be accepted."
Is this experiment a pioneering endeavor in its field?
"Fenebrutinib is the subject of 4 live clinical trials spanning 41 countries and 168 cities. The initial exploration into this medication, conducted by Hoffmann-La Roche in 2020, involved 946 participants and reached its final approval step at Phase 3. Since then, a further 2698 experiments have been carried out with fenebrutinib."
Are there other investigations that have included fenebrutinib?
"At present, fenebrutinib is the focus of 4 live medical studies with 3 in their final phase. Most of these clinical trials are held in Cali and Liguria, however 522 different sites around the world have experiments running concerning this medication."
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