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Immunomodulator

IMU-838 for Multiple Sclerosis (ENSURE-1 Trial)

Phase 3
Recruiting
Led By R. F., MD
Research Sponsored by Immunic AG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patient (age ≥18 to ≤55 years).
Patients with an established diagnosis of MS according to 2017 McDonald Criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 weeks
Awards & highlights

ENSURE-1 Trial Summary

This trial is testing a new drug for people with relapsing MS. It is comparing the new drug to a placebo to see if it is better at reducing MS relapses.

Who is the study for?
Adults aged 18-55 with Relapsing Multiple Sclerosis (RMS), including relapsing-remitting MS and active secondary progressive MS, who've had at least one recent flare-up or positive MRI scan. Participants must be able to follow the study plan and not have other autoimmune diseases, conditions that mimic MS symptoms, certain infections, liver issues, gout, major illnesses affecting study participation or a history of kidney stones.Check my eligibility
What is being tested?
The trial is testing IMU-838 tablets against placebo pills in people with RMS to see if they're effective and safe. It's a large-scale Phase 3 study where participants are randomly assigned to either the medication or placebo group without knowing which one they receive (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 or diarrhea, potential liver function changes due to medication intake, risk of infection from immune system impact and possible allergic reactions.

ENSURE-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old.
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I have been diagnosed with MS according to the 2017 McDonald Criteria.
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I have relapsing-remitting MS or active secondary progressive MS.
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I have had at least 2 flare-ups or a positive brain/spine scan in the last year.

ENSURE-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 weeks for reporting.

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 regarding 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 more

ENSURE-1 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

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

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
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
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

Media Library

IMU-838 (Immunomodulator) Clinical Trial Eligibility Overview. Trial Name: NCT05134441 — Phase 3
Multiple Sclerosis Research Study Groups: IMU-838, Placebo
IMU-838 (Immunomodulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05134441 — Phase 3
Multiple Sclerosis Clinical Trial 2023: IMU-838 Highlights & Side Effects. Trial Name: NCT05134441 — Phase 3

Frequently Asked Questions

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

Does this research project restrict participation to those under 45 years old?

"Eligibility for this trial is restricted to patients that are between 18-55 years old. There are 43 clinical trials for individuals younger than the age of majority and 407 for people older than 65."

Answered by AI

What other similar trials exist for this purpose?

"IMU-838 tablets have been under investigation since 2018. A German company, Immunic AG, sponsored the first trial which took place that year. 263 patients were observed in this initial study. Based on these results, IMU-838 received Phase 2 approval and is currently being trialed in 4 different studies taking place across 27 cities and 25 countries."

Answered by AI

Are there other studies that have looked at the effects of IMU-838 tablets?

"Currently, there are four ongoing clinical trials for IMU-838 tablets, with one in Phase 3. These trials are based in Chisinau, Arizona and 323 other locations across the globe."

Answered by AI

What are the risks of taking IMU-838 tablets?

"IMU-838's position as a Phase 3 trial indicates that there is already some data to support its efficacy and multiple rounds of safety testing have been completed, so our team rates it as a 3 on the Power scale."

Answered by AI

How many test subjects are needed for this clinical trial?

"In order to run this clinical trial, 1050 patients that fit the inclusion criteria are required. Immunic AG will be conducting the study from various sites including Reliant Medical Research in Miami, Florida and Consultants in Neurology Ltd in Northbrook, Illinois."

Answered by AI

Could I potentially take part in this test program?

"This medical study is looking for 1050 individuals between the ages of 18-55 who have been diagnosed with multiple sclerosis according to the 2017 McDonald Criteria. Patients must also fit the following profile: relapsing remitting MS (RRMS) or active secondary progressive MS (as defined by Lublin criteria 1996 and 2014), male or female, at least 2 relapses in past 24 months or 1 relapse in past 12 months, a positive Gd+ MRI scan within last 12 months, willing and able to comply with protocol, and written informed consent given prior to any study-related procedure."

Answered by AI

Are there many places in the city where this research is being conducted?

"At the moment, there are six different sites where patients can enroll in this trial. The locations include Miami, Northbrook, Ormond Beach and six additional places. If you want to limit how much travelling is required, then it would be best to select a location that is close to you."

Answered by AI

Are we looking for more people to participate in this experiment?

"The study, which is detailed on clinicaltrials.gov, is still recruiting patients as of 10/21/2022. It was posted 11/18/2021."

Answered by AI

Who else is applying?

What site did they apply to?
Collier Neurologic Specialists
Bradenton Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis
2021. "Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05134441.
All > Multiple Sclerosis
~127 spots leftby Sep 2024
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