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New pill aims to stop MS relapses in its tracks

NCT ID NCT05134441

Disease control Sponsor: Immunic AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests whether IMU-838 (vidofludimus calcium) can reduce relapses and brain lesions in adults with relapsing multiple sclerosis. Over 1,100 participants are randomly assigned to receive either the drug or a placebo for up to 72 weeks. The study is active but no longer recruiting, and results will show if this oral treatment offers a new way to control the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IMU-838 (vidofludimus calcium) tablets
What this could lead to
If successful, this could provide a new oral treatment option to reduce relapses and brain lesions in people with relapsing multiple sclerosis.
What could go wrong
This is a Phase 3 trial, but results are not yet available. The drug may not prove more effective than placebo, and side effects are still being evaluated.
Why investors are watching

Immunic, Inc. is a very small publicly traded company, and its subsidiary ImmunIC AG is running ENSURE-1, a phase 3 trial testing the drug IMU-838 against a placebo in about 1,121 adults with relapsing multiple sclerosis. For a company this size, this late-stage readout is the main event, because the result will largely determine whether the drug has a future and what the company's value rests on.

If it works: If the trial shows IMU-838 safely reduces relapses better than placebo, Immunic could have a marketable treatment for a common form of multiple sclerosis, which would give the company a major product and a path forward.

If it fails: If the trial fails or is delayed, Immunic would have little to show for its main effort, and the company's prospects would shrink sharply. Phase 3 trials often fail, so a negative result is a real possibility.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,121 people

The number who actually took part.

Started

Nov 2021

Expected to finish

Sep 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female patient (age ≥18 to ≤55 years). * Patients with an established diagnosis of MS according to 2017 McDonald Criteria. * Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and 2014. * Active disease as defined by Lublin 2014 evidenced prior to Screening by: 1. At least 2 relapses in the last 24 months before randomization, or 2. At least 1 relapse in the last 12 months before randomization, or 3. A positive Gd+ MRI scan (brain and/or spine) in the last 12 months prior to randomization. * Willingness and ability to comply with the protocol. * Written informed consent given prior to any study-related procedure. Exclusion Criteria: * 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. * Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-IgG-associated encephalomyelitis * Any active and uncontrolled coexisting autoimmune disease, other than MS (except for type 1 diabetes mellitus and inflammatory bowel disease) * Use of experimental/investigational drug (with the exception ofCOVID-19 vaccines approved by emergency use authorization) and/or participation in drug clinical studies within 6 months prior to Screening * Previous or current use of MS treatments lifelong, or within a pre-specified time period. * Use of the pre-specified concomitant medications. * Clinically significantly abnormal and pre-specified lab values. * History of chronic systemic infections within 6 months before the date of informed consent. * Diagnosis or suspected liver function impairment, which may cause fluctuating liver function tests during this study. * Known history of nephrolithiasis or underlying condition with a strong association of nephrolithiasis. * History or clinical diagnosis of gout. * History or presence of any major medical or psychiatric illness * Substantial medical condition that could create undue risk to the patient, could affect adherence with the study protocol or could undesirably affect study outcomes

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis secondary progressive multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • "Medbud"

    Kyiv, 3037, Ukraine

  • 1st Uni Clinic of Tbilisi LEPL

    Tbilisi, 0141, Georgia

  • AUB Medical Center

    Hamra, 1107-2020, Lebanon

  • Bradenton Research Center

    Bradenton, Florida, 34205, United States

  • CCB Medical Institute Ministry of Interior

    Sofia, 1000, Bulgaria

  • Centro de Morelia

    Morelia, 58000, Mexico

  • Chernihiv Regional Hospital

    Chernivtsi, Ukraine

  • Cliditer S.A de C.V

    Mexico City, 06700, Mexico

  • Clinical Center of Montenegro

    Podgorica, Montenegro

  • Clinical Hospital #15 of the Podilskyi District of the Kyiv City

    Kiev, Ukraine

  • Clinstile SA de CV

    Mexico City, Mexico

  • Collier Neurologic Specialists

    Naples, Florida, 34105, United States

  • Communal Non-Commercial Enterprise "Chernihiv Regional Hospital",Department of Neurology

    Chernihiv, 14029, Ukraine

  • Consultants in Neurology, Ltd

    Northbrook, Illinois, 60062, United States

  • Diagnostic and Consultative Center Neoclinic

    Sofia, 1000, Bulgaria

  • Eristavi Experimental Center

    Tbilisi, Georgia

  • Faicic de RL de CV

    Veracruz, 91900, Mexico

  • General Hospital Niksic

    Nikšić, Montenegro

  • Grupo medico camino SC

    Mexico City, 03310, Mexico

  • Heart and Brain University Hospital

    Pleven, Bulgaria

  • Hospital "8 mi Septemvri"

    Skopje, North Macedonia

  • Hotel Dieu de France Hospital

    Beirut, Lebanon

  • Hygeia Hospital Tirana

    Tirana, Albania

  • Indira Gandhi Medical College & Hospital

    Shimla, 171001, India

  • Instititute of Emergency Medicine

    Chisinau, Moldova

  • Institute of Medical Sciences Banaras Hindu University,IMS BHU Varanasi

    Varanasi, 221005, India

  • Instituto Jalisciense de Metabolismo, SC

    Guadalajara, 44670, Mexico

  • Irbid Speciality Hospital

    Irbid, Jordan

  • Istiklal Hospital

    Amman, 11196, Jordan

  • J.S.C. Curatio Clinic

    Tbilisi, Georgia

  • Jasleen Hospital

    Nagpur, India

  • Jordan University Hospital

    Amman, 11942, Jordan

  • Katsiashvili Emergency Center

    Tbilisi, Georgia

  • Khechinashvili University Hospital

    Tbilisi, Georgia

  • Khmelnytsky regional hospital of war veterans

    Khmelnytskyi, Ukraine

  • Klinika Mjekesore Nuova, Neurology Clinic

    Tirana, 1005, Albania

  • Kyiv City Hospital 4

    Kyiv, Ukraine

  • LTD Aversi Clinic

    Tbilisi, Georgia

  • LTD New Hospitals

    Tbilisi, Georgia

  • Lietuvos Sveikatos Mokslu Universitetas - Kauno Klinikos

    Kaunas, 50161, Lithuania

  • MC Exacta Medica OOD

    Pleven, 5800, Bulgaria

  • MC Vita 1

    Pleven, Bulgaria

  • MHAT "Heart and Brain", EAD

    Burgas, 8000, Bulgaria

  • MHAT "Sveta Sofia" EOOD

    Sofia, 1618, Bulgaria

  • MHAT Avis Medica

    Pleven, 5800, Bulgaria

  • MHAT Puls AD

    Blagoevgrad, 2700, Bulgaria

  • MHATNP "Sveti Naum", EAD

    Sofia, 1113, Bulgaria

  • MHATNPsy Sveti Naum EAD

    Sofia, 1113, Bulgaria

  • Mallikatte, Kadri

    Mangalore, 575002, India

  • MediClub Georgia LLC

    Tbilisi, Georgia

  • Medical and diagnostic center of a LLC "Medcontinent", neurology and rehabilitation center

    Poltava, Ukraine

  • Medico-Sanitary Public Institution, Institute of Neurology and Neurosurgery "Diomid Gherman"

    Chisinau, Moldova

  • Medstar Speciality Hospital

    Bangalore, 560092, India

  • Military Medical Academy

    Sofia, Bulgaria

  • Military Medical Academy MHAT

    Sofia, 1606, Bulgaria

  • NZOZ Neuromed M. i M. Nastaj Sp. P.

    Lublin, 20-064, Poland

  • Neuro Global, LLC

    Ivano-Frankivsk, 76493, Ukraine

  • Neurociencias Estudios Clínicos S.C

    Culiacán, 80020, Mexico

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174, United States

  • Odesa Regional Clinical Hospital, Department of Neurosurgery

    Odesa, Ukraine

  • Pineo Medical Ecosystem LTD

    Tbilisi, Georgia

  • Regina Berkovich MD, PhD Inc. MS Neurology

    West Hollywood, California, 90048, United States

  • Regional Clinical Center for Neurosurgery and Neurology

    Uzhhorod, Ukraine

  • Regional Clinical Hospital

    Ivano-Frankivsk, 76008, Ukraine

  • Regional Municipal Non-commercial Enterprise "Chernivtsi Emergency Medical Hospital"

    Chernivtsi, 58023, Ukraine

  • Ruby Hospital

    Pune, 411001, India

  • SMART medical center

    Kyiv, 4212, Ukraine

  • Sarajishvili Neurology Institute

    Tbilisi, Georgia

  • Sir Ganga Ram Hospital

    New Delhi, 110060, India

  • Sociedad de Metabolismo y Corazon, S.C.

    Veracruz, 91900, Mexico

  • TSH Advanced Clinical Center

    Amman, Jordan

  • Ternopil Psycho-Neuro Hospital

    Ternopil, 46027, Ukraine

  • The Diomid Gherman Institute of Neurology and Neurosurgery

    Chisinau, Moldova

  • UMHAT "Alexandrovska"

    Sofia, 1431, Bulgaria

  • UMHAT "Alexandrovska" EAD

    Sofia, 1431, Bulgaria

  • UMHAT "Kaspela"EOOD

    Plovdiv, 4001, Bulgaria

  • UMHAT "Medica Ruse"

    Rousse, Bulgaria

  • UMHAT "Pulmed" Ltd

    Plovdiv, 4002, Bulgaria

  • UMHAT "Sveta Marina" EAD, First Clinic of Neurological Diseases

    Varna, Bulgaria

  • UMHAT "Sveti Ivan Rilski" EAD

    Sofia, 1000, Bulgaria

  • UMHAT Dr.Georgi Stranski EAD

    Pleven, 5800, Bulgaria

  • UMHAT Sveti Georgi

    Plovdiv, 4002, Bulgaria

  • UMHAT"Tsaritsa Yoanna -ISUL

    Sofia, Bulgaria

  • UMHATEM N.Pirogov

    Sofia, Bulgaria

  • Unidad de Investigación en Salud de Chihuahua S.C.

    Mexico City, 14050, Mexico

  • University Clinic of Neurology

    Skopje, North Macedonia

  • University Hospital Center Ibn Sina, Annaba

    Annaba, 23000, Algeria

  • University Hospital Center Mustapha Pacha, Algiers

    Algiers, 16000, Algeria

  • University Hospital Center of Oran

    Oran, 31000, Algeria

  • University Hospital Muenster, Institute Translational Neurology dept. Neurology

    Münster, 48149, Germany

  • Xenoscience, Inc., 21st Century Neurology

    Phoenix, Arizona, 85004, United States

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