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Immunomodulator
IMU-838 for Multiple Sclerosis (ENSURE-2 Trial)
Phase 3
Recruiting
Led By Robert J. Fox, MD
Research Sponsored by Immunic AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Active disease as defined by Lublin 2014 evidenced prior to Screening by: 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 the last 12 months prior to randomization
Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and 2014
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 weeks
Awards & highlights
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.
Who is the study for?
Adults aged 18-55 with relapsing multiple sclerosis (RMS), including those with active secondary progressive MS, can join this trial. They must have had at least one or two relapses in the past year or two, respectively, or a recent MRI showing disease activity. People with non-active MS types, other similar diseases, kidney stones history, gout, uncontrolled autoimmune conditions besides type 1 diabetes and inflammatory bowel disease are excluded.Check my eligibility
What is being tested?
The ENSURE-2 study is testing the effectiveness of IMU-838 tablets compared to placebo pills in managing RMS. This large-scale phase 3 trial randomly assigns participants to either the medication group or placebo group without them knowing which they're receiving (double-blinded).See study design
What are the potential side effects?
While specific side effects for IMU-838 aren't listed here, common risks may include gastrointestinal issues like nausea and diarrhea; potential liver function changes; risk of infection due to immune system impact; and possible allergic reactions.
ENSURE-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least 2 flare-ups or a positive MRI in the last year.
Select...
I have relapsing-remitting or active secondary progressive MS.
Select...
I am between 18 and 55 years old.
ENSURE-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To evaluate efficacy of IMU-838 versus placebo based on time to first relapse
Secondary outcome measures
Effect of IMU-838 versus placebo on cognitive performance
Effect of IMU-838 versus placebo on disability progression
Effect of IMU-838 versus placebo on volume of new T2 lesions
+2 moreENSURE-2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: IMU-838Experimental Treatment1 Intervention
IMU-838 (vidofludimus calcium), a small molecule inhibitor of DHODH.
Formulation:
Tablets with 15 or 30 mg IMU-838 for once daily oral intake in the morning.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo, as described for the test product, identical number of tablets as given for IMU-838.
Find a Location
Who is running the clinical trial?
Immunic AGLead Sponsor
7 Previous Clinical Trials
2,252 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
1,710 Patients Enrolled for Multiple Sclerosis
Robert J. Fox, MDPrincipal InvestigatorMellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio
2 Previous Clinical Trials
1,500 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
1,500 Patients Enrolled for Multiple Sclerosis
R. F., MDPrincipal InvestigatorUniversity Cleveland Ohio
2 Previous Clinical Trials
1,500 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
1,500 Patients Enrolled for Multiple Sclerosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: IMU-838
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT05201638 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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"
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Kentucky
What site did they apply to?
Baptist Health Lexington
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
Want to help with the research on multiple Sclerosis.
PatientReceived no prior treatments
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