Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New MS pill aims to slash relapses in major trial

NCT ID NCT05201638

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests an oral medication called IMU-838 against a placebo in about 1,100 adults with relapsing multiple sclerosis (MS). The goal is to see if the drug can reduce the number of relapses and new brain lesions over 72 weeks. Participants must be 18-55 years old with active disease, defined by recent relapses.

Why investors are watching

Immunic, Inc. is a very small publicly traded company, and its subsidiary ImmunIC AG is running a Phase 3 trial called ENSURE-2. The trial tests the drug IMU-838 against a placebo in about 1,100 adults with relapsing multiple sclerosis, aiming to see if the drug controls the disease. For a company this size, this late-stage readout is a major event because the result will largely determine the drug's future and the company's prospects.

If it works: If the trial shows IMU-838 works and is safe, the company could move closer to seeking regulatory approval for the drug. That positive result could make the drug a viable treatment option for people with relapsing multiple sclerosis.

If it fails: If the trial fails or is delayed, the drug may not reach the market, which would be a serious setback for a company of this size. Clinical trials often fail, so investors should expect that outcome as 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

1,100 people

The number who actually took part.

Started

Jan 2022

Expected to finish

Oct 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 of COVID-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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Active secondary progressive multiple sclerosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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, relapsing-remitting

Contacts and locations

Locations

  • "University Clinic" of Dnipro State Medical University, Department of Neurology

    Dnipro, 49038, Ukraine

  • 1 Private Clinic Medical Center

    Kyiv, Ukraine

  • 19 Mayis University Medical Faculty Hospital Health Application and Research Center

    Samsun, 55200, Turkey (Türkiye)

  • 5 City Clin Hospital

    Lviv, 79013, Ukraine

  • Adana Baskent Hospital

    Adana, 01250, Turkey (Türkiye)

  • All India Institute of Medical Sciences

    New Delhi, 110029, India

  • Aria Clinic SRL

    Sibiu, 550052, Romania

  • Astra Clinic

    Tallinn, Estonia

  • Bezmialem Vakif University Hospital

    Istanbul, 34093, Turkey (Türkiye)

  • Cantonal Hospital Bihac Dr. Irfan Ljubijankic

    Bihać, 77000, Bosnia and Herzegovina

  • Centrum Med. Ibismed

    Zabrze, Poland

  • Centrum Medyczne NeuroProtect

    Warsaw, 01684, Poland

  • Chernihiv City Hospital 4

    Chernihiv, Ukraine

  • City Clinical Hospital 2

    Rivne, Ukraine

  • Clubul Sanatatii SRL

    Campulung Muscel, 115100, Romania

  • Communal Non-Commercial Medical Enterprise "O.T.Bohayevskyi Kremenchuk City Hospital #1

    Kremenchuk, 39623, Ukraine

  • Communal institution "City Clinical Hospital №3" of Poltava City Council

    Poltava, 36000, Ukraine

  • Communal noncommercial enterprise "First Cherkasy City Hospital"

    Cherkasy, 18009, Ukraine

  • DKS PGI

    Raipur, 492001, India

  • Dnipro City Hospital 6

    Dnipro, Ukraine

  • Dopomoga Plus medical center

    Kyiv, Ukraine

  • Dr Ram Manohar Lohia Institute of Medical Sciences

    Lucknow, 226010, India

  • Erebouni Medical Center

    Yerevan, 0087, Armenia

  • Fortis Memorial Research Institute

    Gurugramam, 122002, India

  • FutureMeds Warszawa Centrum

    Warsaw, Poland

  • GB Pant Institute of Postgraduate Medical Education and Research

    New Delhi, 110056, India

  • General Hospital Leskovac

    Leskovac, 16000, Serbia

  • General Hospital Uzice

    Užice, 31000, Serbia

  • Haydar Pasa Num. EAH

    Istanbul, Turkey (Türkiye)

  • Healthcare Innovations

    Coral Springs, Florida, 33067, United States

  • Heratsi Hospital Complex 1

    Yerevan, 0025, Armenia

  • Hospital Nacional Dos de Mayo

    Lima, 15003, Peru

  • Hsptl Sveti Vracevi

    Novi Kneževac, Serbia

  • Indywidualna Praktyka Lekarska prof. Konrad Rejdak

    Lublin, 20-410, Poland

  • Instytut Zdrowia Boczarska

    Oświęcim, 32-600, Poland

  • Klinicko Bolnicki centar Zemun

    Zemun, 11080, Serbia

  • Klinicko bolnicki centar Dr Dragisa Misovic - Dedinje

    Belgrade, 11000, Serbia

  • Klinicko bolnicki centar Zvezdara

    Belgrade, 11000, Serbia

  • Kocaeli University Research and Application Hospital

    Kocaeli, 41000, Turkey (Türkiye)

  • Kutahya Uni Evliya Celebi Hspt

    Kütahya, 43040, Turkey (Türkiye)

  • Lviv Regional Central Hospital

    Lviv, 79010, Ukraine

  • MS Diagnosis Treatment Center

    Cherkasy, Ukraine

  • Manisa Celal Bayar University Hafsa Sultan Hospital

    Manisa, 45030, Turkey (Türkiye)

  • Municipal Institution "Dnipropetrovsk Regional Rehabilitation Hospital" of Dnipropetrovsk Regional Council"

    Dnipro, 49000, Ukraine

  • NZOZ Hertmanowskiej

    Plewiska, 62-064, Poland

  • NZOZ Neuro-Kard

    Poznan, 61-853, Poland

  • NZOZ Neuromed

    Lublin, 20-064, Poland

  • NZOZ Novo-Med

    Katowice, 40-584, Poland

  • NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"

    Katowice, 40123, Poland

  • Namik Kemal Uni Hospital

    Tekirdağ, 59100, Turkey (Türkiye)

  • Neuro of Central Florida

    Altamonte Springs, Florida, 32714, United States

  • Neuro-Medic Janusz Zbrojkiewicz

    Katowice, 40686, Poland

  • Opsta bolnica Djordje Jovanovic Zrenjanin

    Zrenjanin, 23000, Serbia

  • Polakulath Narayanan Renai Medicity MSSH

    Kochi, 682025, India

  • Post-Graduation Institute of Medical Education and Research (PGIMER)

    Chandigarh, 160012, India

  • Royal Hallamshire Hospital

    Sheffield, United Kingdom

  • SRI Guru Ram Das Institute of Medical Sciences and Research

    Punjābi Bāgh, 143006, India

  • Saint Gregory the Illuminator Medical Center

    Yerevan, 0056, Armenia

  • Sakarya Egitim ve Arastirma Hast

    Sakarya, 54100, Turkey (Türkiye)

  • Salutem

    Vinnytsia, 21018, Ukraine

  • Sancaktepe Sehit Prof.Dr. Ilhan Varank Training and Research Hospital

    Istanbul, 34785, Turkey (Türkiye)

  • Spitalul clinic CF Constanta

    Constanța, 900123, Romania

  • State Institution "National Research Center for Radiation Medicine of the National Academy of Medical Sciences of Ukraine

    Kyiv, 03115, Ukraine

  • Sumy Reg Clinical Hospital

    Sumy, Ukraine

  • T.C. Ministry of Health Istanbul Haseki Training and Research Hospital

    Istanbul, 34250, Turkey (Türkiye)

  • UCC of Rep of Srpska

    Banja Luka, Bosnia and Herzegovina

  • Ukrainian State Research Institute of Medico-Social Problems of Disability

    Dnipro, 49027, Ukraine

  • Uludag University Hospital

    Bursa, 16059, Turkey (Türkiye)

  • University Clinical Center Sarajevo

    Sarajevo, 71000, Bosnia and Herzegovina

  • University Clinical Center Tuzla

    Tuzla, 75000, Bosnia and Herzegovina

  • University Clinical Center of Sarajevo

    Sarajevo, 71000, Bosnia and Herzegovina

  • University Hospital Muenster, Institute Translational Neurology dept. Neurology

    Münster, 48149, Germany

  • Univerzitetski Klinicki centar Kragujevac

    Kragujevac, 34000, Serbia

  • Univerzitetski Klinicki centar Nis

    Niš, 18000, Serbia

  • Vojnomedicinska akademija

    Belgrade, 11000, Serbia

  • Volyn Reg Clin Hospital

    Lutsk, 43005, Ukraine

More trials for these conditions

Other studies related to the condition(s) this trial covers.