Study to Evaluate the Efficacy, Safety and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis

NCT05201638 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: P3-IMU-838-RMS-02
• Study Type: interventional
• Target: 1,100
• Locations: 13 countries
• Sites: 76

Brief Summary

Multi-Center, Randomized, Double-Blinded Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 versus Placebo in Adults with Relapsing Multiple Sclerosis (ENSURE-2)

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (1)

• To evaluate efficacy of IMU-838 versus placebo based on time to first relapse

  Survival analysis of time to first relapse, occurred after the start of study treatment administration and before the end of the double-blind period, censored at a maximum of 72 weeks.

  72 weeks

Secondary Outcomes (5)

• Effect of IMU-838 versus placebo on volume of new T2 lesions

  72 weeks

• Effect of IMU-838 versus placebo on disability progression

  72 weeks

• Effect of IMU-838 versus placebo on cognitive performance

  72 weeks

• Effect of IMU-838 versus placebo on whole brain atrophy

  72 weeks

• Safety of IMU-838 versus placebo

  72 weeks

Study Arms (2)

IMU-838

EXPERIMENTAL

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.

Drug: IMU-838 tablets

Placebo

PLACEBO COMPARATOR

Matching placebo, as described for the test product, identical number of tablets as given for IMU-838.

Drug: Placebo matching IMU-838 tablets

Interventions

IMU-838 tablets DRUG

Patients are randomized to IMU-838 or placebo in ratio 1:1

Also known as: Vidofludimus calcium

IMU-838

Placebo matching IMU-838 tablets DRUG

Patients are randomized to IMU-838 or placebo in ratio 1:1

Also known as: Placebo matching vidofludimus calcium

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• At least 2 relapses in the last 24 months before randomization, or
• At least 1 relapse in the last 12 months before randomization, or
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Immunic AG: lead

Study Sites (76)

Neuro of Central Florida

Altamonte Springs, Florida, 32714, United States

Location

Healthcare Innovations

Coral Springs, Florida, 33067, United States

Location

Heratsi Hospital Complex 1

Yerevan, 0025, Armenia

Location

Saint Gregory the Illuminator Medical Center

Yerevan, 0056, Armenia

Location

Erebouni Medical Center

Yerevan, 0087, Armenia

Location

UCC of Rep of Srpska

Banja Luka, Bosnia and Herzegovina

Location

Cantonal Hospital Bihac Dr. Irfan Ljubijankic

Bihać, 77000, Bosnia and Herzegovina

Location

University Clinical Center of Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

University Clinical Center Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

University Clinical Center Tuzla

Tuzla, 75000, Bosnia and Herzegovina

Location

Astra Clinic

Tallinn, Estonia

Location

University Hospital Muenster, Institute Translational Neurology dept. Neurology

Münster, 48149, Germany

Location

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

Chandigarh, 160012, India

Location

Fortis Memorial Research Institute

Gurugramam, 122002, India

Location

Polakulath Narayanan Renai Medicity MSSH

Kochi, 682025, India

Location

Dr Ram Manohar Lohia Institute of Medical Sciences

Lucknow, 226010, India

Location

All India Institute of Medical Sciences

New Delhi, 110029, India

Location

GB Pant Institute of Postgraduate Medical Education and Research

New Delhi, 110056, India

Location

SRI Guru Ram Das Institute of Medical Sciences and Research

Punjābi Bāgh, 143006, India

Location

DKS PGI

Raipur, 492001, India

Location

Hospital Nacional Dos de Mayo

Lima, 15003, Peru

Location

NZOZ Novo-Med

Katowice, 40-584, Poland

Location

NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"

Katowice, 40123, Poland

Location

Neuro-Medic Janusz Zbrojkiewicz

Katowice, 40686, Poland

Location

NZOZ Neuromed

Lublin, 20-064, Poland

Location

Indywidualna Praktyka Lekarska prof. Konrad Rejdak

Lublin, 20-410, Poland

Location

Instytut Zdrowia Boczarska

Oświęcim, 32-600, Poland

Location

NZOZ Hertmanowskiej

Plewiska, 62-064, Poland

Location

NZOZ Neuro-Kard

Poznan, 61-853, Poland

Location

Centrum Medyczne NeuroProtect

Warsaw, 01684, Poland

Location

FutureMeds Warszawa Centrum

Warsaw, Poland

Location

Centrum Med. Ibismed

Zabrze, Poland

Location

Clubul Sanatatii SRL

Campulung Muscel, 115100, Romania

Location

Spitalul clinic CF Constanta

Constanța, 900123, Romania

Location

Aria Clinic SRL

Sibiu, 550052, Romania

Location

Klinicko bolnicki centar Dr Dragisa Misovic - Dedinje

Belgrade, 11000, Serbia

Location

Klinicko bolnicki centar Zvezdara

Belgrade, 11000, Serbia

Location

Vojnomedicinska akademija

Belgrade, 11000, Serbia

Location

Univerzitetski Klinicki centar Kragujevac

Kragujevac, 34000, Serbia

Location

General Hospital Leskovac

Leskovac, 16000, Serbia

Location

Univerzitetski Klinicki centar Nis

Niš, 18000, Serbia

Location

Hsptl Sveti Vracevi

Novi Kneževac, Serbia

Location

General Hospital Uzice

Užice, 31000, Serbia

Location

Klinicko Bolnicki centar Zemun

Zemun, 11080, Serbia

Location

Opsta bolnica Djordje Jovanovic Zrenjanin

Zrenjanin, 23000, Serbia

Location

Adana Baskent Hospital

Adana, 01250, Turkey (Türkiye)

Location

Uludag University Hospital

Bursa, 16059, Turkey (Türkiye)

Location

Bezmialem Vakif University Hospital

Istanbul, 34093, Turkey (Türkiye)

Location

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

Istanbul, 34250, Turkey (Türkiye)

Location

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

Istanbul, 34785, Turkey (Türkiye)

Location

Haydar Pasa Num. EAH

Istanbul, Turkey (Türkiye)

Location

Kocaeli University Research and Application Hospital

Kocaeli, 41000, Turkey (Türkiye)

Location

Kutahya Uni Evliya Celebi Hspt

Kütahya, 43040, Turkey (Türkiye)

Location

Manisa Celal Bayar University Hafsa Sultan Hospital

Manisa, 45030, Turkey (Türkiye)

Location

Sakarya Egitim ve Arastirma Hast

Sakarya, 54100, Turkey (Türkiye)

Location

19 Mayis University Medical Faculty Hospital Health Application and Research Center

Samsun, 55200, Turkey (Türkiye)

Location

Namik Kemal Uni Hospital

Tekirdağ, 59100, Turkey (Türkiye)

Location

Communal noncommercial enterprise "First Cherkasy City Hospital"

Cherkasy, 18009, Ukraine

Location

MS Diagnosis Treatment Center

Cherkasy, Ukraine

Location

Chernihiv City Hospital 4

Chernihiv, Ukraine

Location

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

Dnipro, 49000, Ukraine

Location

Ukrainian State Research Institute of Medico-Social Problems of Disability

Dnipro, 49027, Ukraine

Location

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

Dnipro, 49038, Ukraine

Location

Dnipro City Hospital 6

Dnipro, Ukraine

Location

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

Kremenchuk, 39623, Ukraine

Location

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

Kyiv, 03115, Ukraine

Location

1 Private Clinic Medical Center

Kyiv, Ukraine

Location

Dopomoga Plus medical center

Kyiv, Ukraine

Location

Volyn Reg Clin Hospital

Lutsk, 43005, Ukraine

Location

Lviv Regional Central Hospital

Lviv, 79010, Ukraine

Location

5 City Clin Hospital

Lviv, 79013, Ukraine

Location

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

Poltava, 36000, Ukraine

Location

City Clinical Hospital 2

Rivne, Ukraine

Location

Sumy Reg Clinical Hospital

Sumy, Ukraine

Location

Salutem

Vinnytsia, 21018, Ukraine

Location

Royal Hallamshire Hospital

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Robert J. Fox, MD

  Mellen Center for MS, Neurological Institute, Cleveland Clinic, Ohio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 21, 2022
• Study Start: January 12, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): October 1, 2033
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (12); GB (1); BO (5); IN (8); UA (18); PE (1); ES (1); US (2); AR (3); DE (1); PL (11); RO (3); SE (10)