🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT05134441
Active, not recruiting Phase 3

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

NCT05134441 · tracked via the Priya Life Science India tracker
Sponsor
Immunic AG
Phase
Phase 3
Started
2021-11-18
Last updated
2026-02-23

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

IMU-838 tabletsPlacebo matching IMU-838 tablets

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

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

Study 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-1)

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (91)

FacilityCityRegionStatus
Xenoscience, Inc., 21st Century Neurology Phoenix Arizona
Regina Berkovich MD, PhD Inc. MS Neurology West Hollywood California
Bradenton Research Center Bradenton Florida
Collier Neurologic Specialists Naples Florida
Neurology Associates of Ormond Beach Ormond Beach Florida
Consultants in Neurology, Ltd Northbrook Illinois
Klinika Mjekesore Nuova, Neurology Clinic Tirana Albania
Hygeia Hospital Tirana Tirana Albania
University Hospital Center Mustapha Pacha, Algiers Algiers Algeria
University Hospital Center Ibn Sina, Annaba Annaba Algeria
University Hospital Center of Oran Oran Algeria
MHAT Puls AD Blagoevgrad Bulgaria
MHAT "Heart and Brain", EAD Burgas Bulgaria
MC Exacta Medica OOD Pleven Bulgaria
MHAT Avis Medica Pleven Bulgaria
UMHAT Dr.Georgi Stranski EAD Pleven Bulgaria
Heart and Brain University Hospital Pleven Bulgaria
MC Vita 1 Pleven Bulgaria
UMHAT "Kaspela"EOOD Plovdiv Bulgaria
UMHAT "Pulmed" Ltd Plovdiv Bulgaria
UMHAT Sveti Georgi Plovdiv Bulgaria
UMHAT "Medica Ruse" Rousse Bulgaria
CCB Medical Institute Ministry of Interior Sofia Bulgaria
Diagnostic and Consultative Center Neoclinic Sofia Bulgaria
UMHAT "Sveti Ivan Rilski" EAD Sofia Bulgaria
MHATNP "Sveti Naum", EAD Sofia Bulgaria
MHATNPsy Sveti Naum EAD Sofia Bulgaria
UMHAT "Alexandrovska" EAD Sofia Bulgaria
UMHAT "Alexandrovska" Sofia Bulgaria
Military Medical Academy MHAT Sofia Bulgaria
MHAT "Sveta Sofia" EOOD Sofia Bulgaria
Military Medical Academy Sofia Bulgaria
UMHAT"Tsaritsa Yoanna -ISUL Sofia Bulgaria
UMHATEM N.Pirogov Sofia Bulgaria
UMHAT "Sveta Marina" EAD, First Clinic of Neurological Diseases Varna Bulgaria
1st Uni Clinic of Tbilisi LEPL Tbilisi Georgia
Eristavi Experimental Center Tbilisi Georgia
J.S.C. Curatio Clinic Tbilisi Georgia
Katsiashvili Emergency Center Tbilisi Georgia
Khechinashvili University Hospital Tbilisi Georgia

+ 51 more sites — see the full list on the official registry below.

More Immunic AG trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05134441 on ClinicalTrials.gov ↗ ← All trials in India