What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include interferon beta, glatiramer acetate, fingolimod, and dimethyl fumarate. Interferon beta can cause flu-like symptoms, injection site reactions, and elevated liver enzymes. Glatiramer acetate is associated with local injection site reactions and, rarely, systemic post-injection reactions. Fingolimod may lead to headache, elevated liver enzymes, bradyarrhythmia, macular edema, and increased risk of infections. Dimethyl fumarate commonly causes flushing, gastrointestinal issues, and may also elevate liver enzymes. These treatments aim to reduce relapse rates and slow disease progression but come with varying side effect profiles.

What prior FDA approvals exist?

IMU-838 is a Dihydroorotate Dehydrogenase Inhibitor, a class of drugs that targets the immune system by inhibiting pyrimidine synthesis. A similar FDA-approved drug for Multiple Sclerosis is teriflunomide, which also inhibits dihydroorotate dehydrogenase. Teriflunomide is used to reduce the frequency of relapses and delay physical disability in patients with relapsing forms of MS. Other FDA-approved treatments for MS include interferon beta formulations, glatiramer acetate, and newer oral medications like dimethyl fumarate and fingolimod, which modulate the immune response to reduce disease activity.

What other types of research exist?

Promising novel alternatives to IMU-838 for Multiple Sclerosis patients include: 1) Dimethyl fumarate (BG-12), which has shown significant reductions in relapse rates and new brain lesions in clinical trials. 2) Lemborexant, a dual orexin receptor antagonist, which has demonstrated long-term efficacy and safety in treating insomnia associated with MS. 3) Daridorexant, another dual orexin receptor antagonist, which has shown positive results in phase 3 trials for insomnia in MS patients. These alternatives offer different mechanisms of action and have shown promising results in clinical studies.

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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

Pivotal Trial

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My MS is in a non-active, progressive stage.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 weeks for reporting.

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 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 10Eligibility criteria met

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.