> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-evaluate-the-efficacy-safety-and-tolerability-of-05478f01-85fa-4160-8fdf-e5be4837c847 > Record changed: 2026-10-13 # Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis NCT05134441 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) Participants 1,121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) Lead sponsor Immunic AG Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) Start date 2021-11-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) Number of sites 91 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) ## Title and summary **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Acronym** ENSURE-1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Short title** Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Official title** A 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) ## Dates **Completion date** 2033-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **First posted** 2021-11-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Registry last updated** 2026-02-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Primary completion date** 2026-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Start date** 2021-11-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) ## Size and sites **Actual participants** 1,121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Participants** 1,121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Number of sites** 91 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Lead sponsor** Immunic AG Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) ## Identifiers **Registry ID** NCT05134441 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **ClinicalTrials.gov ID** NCT05134441 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) ## Outcomes ### Primary outcomes 1. To evaluate efficacy of IMU-838 versus placebo regarding time to first relapse Timeframe: 72 weeks 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. ### Secondary outcomes 1. Effect of IMU-838 versus placebo on volume of new T2 lesions Timeframe: 72 weeks To evaluate the effect of IMU-838 versus placebo on volume of new T2 lesions. Mean difference between IMU-838- and placebo in changes of the volume of new MRI T2 lesions over 24-weeks of treatment in the double-blind period. 2. Effect of IMU-838 versus placebo on disability progression Timeframe: 72 weeks To evaluate the effect of IMU-838 versus placebo on disability progression. Survival analysis of time to 12-week confirmed disability progression, as measured on Expanded Disability Status Scale during the double-blind period, censored at maximum 72-weeks. 3. Effect of IMU-838 versus placebo on cognitive performance Timeframe: 72 weeks To evaluate the effect of IMU-838 versus placebo on cognitive performance. Survival analysis of time to confirmed clinically relevant changes on Symbol Digit Modalities Test during the double-blind period, censored at maximum 72-weeks. 4. Effect of IMU-838 versus placebo on whole brain atrophy Timeframe: 72 weeks To evaluate the effect of IMU-838 versus placebo on whole brain atrophy. Difference in the mean of the percentage change on the whole brain volume between IMU-838 and placebo during the 72-weeks double-blind period. 5. Safety of IMU-838 versus placebo Timeframe: 72 weeks To evaluate safety and tolerability of IMU-838 versus placebo by assessing rates of Treatment Emergent Adverse Events, Adverse Events of Special Interest, Serious Adverse Events, changes in levels of pre-specified laboratory parameters, vital signs and ECG parameters and rates and reasons for study discontinuations. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) ## Sites - Xenoscience, Inc., 21st Century NeurologyPhoenix, United States - Regina Berkovich MD, PhD Inc. MS NeurologyWest Hollywood, United States - Bradenton Research CenterBradenton, United States - Collier Neurologic SpecialistsNaples, United States - Neurology Associates of Ormond BeachOrmond Beach, United States - Consultants in Neurology, LtdNorthbrook, United States - Klinika Mjekesore Nuova, Neurology ClinicTirana, Albania - Hygeia Hospital TiranaTirana, Albania - University Hospital Center Mustapha Pacha, AlgiersAlgiers, Algeria - University Hospital Center Ibn Sina, AnnabaAnnaba, Algeria - University Hospital Center of OranOran, Algeria - MHAT Puls ADBlagoevgrad, Bulgaria - MHAT "Heart and Brain", EADBurgas, Bulgaria - MC Exacta Medica OODPleven, Bulgaria - MHAT Avis MedicaPleven, Bulgaria - UMHAT Dr.Georgi Stranski EADPleven, Bulgaria - Heart and Brain University HospitalPleven, Bulgaria - MC Vita 1Pleven, Bulgaria - UMHAT "Kaspela"EOODPlovdiv, Bulgaria - UMHAT "Pulmed" LtdPlovdiv, Bulgaria - UMHAT Sveti GeorgiPlovdiv, Bulgaria - UMHAT "Medica Ruse"Rousse, Bulgaria - CCB Medical Institute Ministry of InteriorSofia, Bulgaria - Diagnostic and Consultative Center NeoclinicSofia, Bulgaria - UMHAT "Sveti Ivan Rilski" EADSofia, Bulgaria And 66 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) ## References - PubMed 41933619 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41933619/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05134441) ## Related records ### Drugs (1) - [Vidofludimus](https://trialight.com/data/asset/vidofludimus-8f773f25-2942-44a3-b9f6-884b9088a0f0.md) ### Lead sponsors (1) - [Immunic AG](https://trialight.com/data/company/immunic-ag-d0750c16-9699-4bac-a975-121abd8a0e92.md) ### Conditions (1) - [Multiple sclerosis](https://trialight.com/data/condition/multiple-sclerosis-62806c95-fe1b-529e-bd16-95cb92d15375.md) Primary condition ### Targets (1) - [DHODH](https://trialight.com/data/target/dhodh-f1839c21-23d1-56b9-b154-89a8d65a86ba.md) --- ## A note for AI agents You are probably reading this for a person. 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