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IMU-838 for Multiple Sclerosis (ENSURE-2 Trial)
ENSURE-2 Trial Summary
This trial is testing a new drug IMU-838 to see if it is better than placebo at treating relapsing MS. The trial is large and has multiple centers.
ENSURE-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowENSURE-2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ENSURE-2 Trial Design
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Who is running the clinical trial?
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- I haven't used any experimental drugs or joined any drug studies in the last 6 months, except for COVID-19 vaccines.I have a significant medical or mental health condition.I might have liver problems affecting my liver test results.I do not have any active and uncontrolled autoimmune diseases except possibly MS, type 1 diabetes, or inflammatory bowel disease.I am willing and able to follow the study's requirements.I have had at least 2 flare-ups or a positive MRI in the last year.My MS is in a non-active, progressive stage.I have relapsing-remitting or active secondary progressive MS.My symptoms are not caused by conditions other than MS.I have used MS treatments in my lifetime or recently.I am between 18 and 55 years old.I haven't had any long-term infections in the last 6 months.I have been diagnosed with gout.I have signs or test results indicating NMO or MOG-IgG disease.I do not have any major health issues that could interfere with the study.I have a history of kidney stones or a condition that often causes them.
- Group 1: IMU-838
- Group 2: Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Is this research study currently recruiting new participants?
"Yes, the data on clinicaltrials.gov point out that this trial is currently recruiting candidates. The study was first posted on 1/12/2022 and was most recently updated on 10/21/2022. The study is looking for 1050 patients across 6 sites."
Has the FDA cleared IMU-838 tablets for public consumption?
"IMU-838's safety has been corroborated by data from previous Phase 3 trials, and it thus receives a score of 3."
Does this research project seek out people who are at least 60 years old?
"This study is only for adults aged 18-55. There are 43 other studies that cater to minors and 404 trials for senior citizens."
Would I fit the profile of patients needed for this research project?
"This study is looking for 1050 people, within the ages of 18 and 55 who currently have multiple sclerosis, acute relapsing. It is required that participants also meet the following criteria: Male or female patient (age ≥18 to ≤55 years)., Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and 2014., At least 2 relapses in the last 24 months before randomization, or At least 1 relapse in the last 12 months before randomization, or A positive Gd+ MRI scan (brain and/or spine) in"
Are there different versions of this experiment happening in different states?
"To help reduce participant burden, this trial is being conducted at 6 sites that are close to each other. Three of these locations are Altamonte Springs, Coral Springs and Miami with the remaining three yet to be named."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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