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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.
Must not have
Patients with non-active secondary progressive MS and primary progressive MS.
Any disease other than MS that may better explain the signs and symptoms, including history of complete transverse myelitis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 weeks
Awards & highlights
Summary
This trial is testing IMU-838, a medication for adults with relapsing multiple sclerosis. The drug aims to reduce immune system activity to prevent nerve damage and manage symptom flare-ups.
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.
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).
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My MS is in a non-active, progressive stage.
Select...
My symptoms are not caused by conditions other than MS.
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I have signs or test results indicating NMO or MOG-IgG disease.
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I have a history of kidney stones or a condition that often causes them.
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I have been diagnosed with gout.
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I have a significant medical or mental health condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To evaluate efficacy of IMU-838 versus placebo regarding time to first relapse
Secondary study objectives
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 moreTrial 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Multiple Sclerosis (MS) treatments primarily aim to modulate the immune system to reduce inflammation and prevent further neurological damage. Common disease-modifying therapies (DMTs) include beta interferons, which reduce the frequency of relapses by modulating immune response, and glatiramer acetate, which acts as a decoy for immune cells.
Dihydroorotate Dehydrogenase (DHODH) inhibitors, such as the investigational drug IMU-838, work by inhibiting pyrimidine synthesis, which is crucial for the proliferation of activated lymphocytes. This mechanism is particularly important for MS patients as it helps to limit the autoimmune attack on the central nervous system, potentially reducing disease activity and progression.
Understanding these mechanisms allows patients and clinicians to make informed decisions about treatment options based on efficacy and safety profiles.
Mode of action and clinical studies with alemtuzumab.Disease-modifying treatments for progressive multiple sclerosis.
Mode of action and clinical studies with alemtuzumab.Disease-modifying treatments for progressive multiple sclerosis.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with MS according to the 2017 McDonald Criteria.I have relapsing-remitting MS or active secondary progressive MS.I have signs or test results indicating NMO or MOG-IgG disease.My symptoms are not caused by conditions other than MS.I have had at least 2 flare-ups or a positive brain/spine scan in the last year.I have not had a long-term infection in the last 6 months.I am between 18 and 55 years old.I have been diagnosed with gout.I have a significant medical or mental health condition.I do not have any major health issues that could risk my safety or affect the study results.I might have liver problems affecting my liver test results.I do not have an active autoimmune disease, except possibly MS, type 1 diabetes, or inflammatory bowel disease.I have used MS treatments in the past or am currently using them.I haven't used any experimental drugs or joined any drug studies in the last 6 months, except for COVID-19 vaccines.My MS is in a non-active, progressive stage.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
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.
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.
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