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

NCT05134441
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,121
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Lead sponsor
Immunic AG
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Start date
2021-11-18
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Number of sites
91
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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)
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Acronym
ENSURE-1
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Short title
Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis
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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)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2033-09-01
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First posted
2021-11-26
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Registry last updated
2026-02-23
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Primary completion date
2026-11-01
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Start date
2021-11-18
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Actual participants
1,121
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Participants
1,121
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
91
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Registry sponsor category
Industry
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Lead sponsor
Immunic AG
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05134441
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ClinicalTrials.gov ID
NCT05134441
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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.

  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
clinicaltrials.gov

Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
No

  • 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.

  • 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
clinicaltrials.gov

  • 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
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Sources for references
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)