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    Summary
    EudraCT Number:2021-000028-36
    Sponsor's Protocol Code Number:P3-IMU-838-RMS-01
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-11-04
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedLithuania - SMCA
    A.2EudraCT number2021-000028-36
    A.3Full title of the trial
    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)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not applicable
    A.3.2Name or abbreviated title of the trial where available
    ENSURE-1
    A.4.1Sponsor's protocol code numberP3-IMU-838-RMS-01
    A.5.4Other Identifiers
    Name:INDNumber:146381
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorImmunic AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportImmunic AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmunic AG
    B.5.2Functional name of contact pointDarius-Jean Namdjou
    B.5.3 Address:
    B.5.3.1Street AddressLochhamer Schlag 21
    B.5.3.2Town/ cityGräfelfing
    B.5.3.3Post code82166
    B.5.3.4CountryGermany
    B.5.4Telephone number+491725852987
    B.5.6E-maildarius-jean.namdjou@imux.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namevidofludimus calcium
    D.3.2Product code IMU-838
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVidofludimus calcium
    D.3.9.1CAS number 1354012-90-0
    D.3.9.2Current sponsor codeIM90838
    D.3.9.3Other descriptive nameIMU-838
    D.3.9.4EV Substance CodeSUB199342
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVidofludimus calcium
    D.3.2Product code IMU-838
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVidofludimus calcium
    D.3.9.1CAS number 1354012-90-0
    D.3.9.2Current sponsor codeIM90838
    D.3.9.3Other descriptive nameIMU-838
    D.3.9.4EV Substance CodeSUB199342
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing Multiple Sclerosis
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10080700
    E.1.2Term Relapsing multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of IMU-838 versus placebo in adult patients with active RMS in delaying the occurrences of relapses based on time to first relapse (T2FR)
    E.2.2Secondary objectives of the trial
    To evaluate the effect of IMU-838 versus placebo on volume of new T2 lesions;
    To evaluate the effect of IMU-838 versus placebo on disability progression;
    To evaluate the effect of IMU-838 versus placebo on cognitive performance;
    To evaluate the effect of IMU-838 versus placebo on whole brain atrophy;
    Please refer to the study protocol for further secondary objective.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Main study (DB) inclusion criteria:
    1. Male or female patient (age ≥18 to ≤55 years)
    2. Patients with an established diagnosis of MS according to 2017 McDonald Criteria
    3. Patients with RMS comprising of relapsing remitting MS (RRMS) and active secondary progressive MS, both defined according to Lublin criteria 1996 and 2014. Patients are eligible for this trial if their disease modifying treatment has failed due to efficacy, safety, or tolerability issues, if they have contraindications or no access to treatment, or if they refuse the offered MS treatment.
    4. Active disease as defined by Lublin 2014 evidenced prior to Screening by:
    a.At least 2 relapses(a) in the last 24 months before randomization, or
    b.At least 1 relapse(a) in the last 12 months before randomization, or
    c.A positive Gd+ MRI scan (brain and/or spine) in the last 12 months prior to randomization.
    (a) Relapses must have been assessed and documented by a physician in the patient files.
    5. EDSS score between 0 and 5.5 (inclusive) at SV1.
    Female patients:
    a. must be of non-childbearing potential, ie, surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before SV1) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or
    b. if of childbearing potential, must have a negative pregnancy test at SV1 (blood test) and before the first IMP intake (Day 1 blood or urine test). They must agree not to attempt to become pregnant, must not donate ova, and must use a highly effective contraceptive method (see below) together with a barrier method between study consent and 30 days after the last intake of the IMP.
    c.highly effective forms of birth control are those with a failure rate less than 1% per year and include:
    i.oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraceptives associated with inhibition of ovulation.
    ii.oral, injectable, or implantable progestogen-only hormonal contraceptives associated with inhibition of ovulation.
    iii.intrauterine device or intrauterine hormone-releasing system.
    iv.bilateral tubal occlusion.
    v.vasectomized partner (ie, the patient’s male partner underwent effective surgical sterilization before the female patient entered the clinical study. and is the sole sexual partner of the female patient during the clinical study).
    vi.sexual abstinence (acceptable only if it is the patient’s usual form of birth control/lifestyle choice; periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception).
    d.Barrier methods of contraception include:
    i.condom.
    ii.occlusive cap (diaphragm or cervical/vault caps) with spermicidal gel/film/cream/suppository.
    7. Male patients must agree not to father a child or to donate sperm starting at SV1, throughout the clinical study, and for 30 days after the last intake of the IMP. Male patients must also:
    a. abstain from sexual intercourse with a female partner (acceptable only if it is the patient’s usual form of birth control/lifestyle choice), or
    b. use adequate barrier contraception during treatment with the IMP and until at least 30 days after the last intake of the IMP, and
    c. if they have a female partner of childbearing potential, the partner should use a highly effective contraceptive method as outlined in inclusion criterion 5.
    d. if they have a pregnant partner, they must use condoms while taking the IMP to avoid exposure of the fetus to the IMP.
    8. Willingness and ability to comply with the protocol.
    9. Patients are able to read and understand the given
    information about the study (including their language capabilities) and provide written informed consent prior to any study-related procedure.
    Extension period (OL) inclusion criteria:
    1.Completed full visit schedule of the MP up to 72 weeks of (with the V8/EOMP completed and no more than 1 regular study visit omitted), independent of the patient’s treatment:
    a.Double-blind treatment, or
    b.Open-label rescue IMU-838 treatment, or
    c.Rescue treatment outside this trial (observational phase) but with double-blind treatment of at least 24 weeks in this trial and approved by the sponsor.
    2.Performed a full and complete Week 72 visit (Visit 8; which also serves as an EOMP visit and includes the Visit 8 MRI examination).
    E.4Principal exclusion criteria
    Main period (DB) exclusion criteria:
    1. Patients with non-active secondary progressive MS and primary progressive MS.
    2. Any disease other than MS that may better explain the signs and symptoms, including history of complete transverse myelitis.
    3. Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-IgG-associated encephalomyelitis.
    4. Any MRI finding, which puts in question the MS diagnosis, including but not limited to a longitudinally extensive spinal cord lesion.
    5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or adequately treated cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of full remission at the current time.
    6. Any active and uncontrolled coexisting autoimmune disease, other than MS (except for type 1 diabetes mellitus and inflammatory bowel disease).
    7. An MS relapse ending within 30 days before SV1 and/or during the Screening Period (until Day 1).
    8. Any corticosteroid treatment for relapse given within 30 days before SV2.

    Please refer to protocol for further DB exclusion criteria (Therapy, immune response, other medical history and concomitant disease as well as general exclusion criteria).

    Extension period (OL) exclusion criteria:
    1.Any ongoing, clinically significant (as assessed by the investigator) TEAE (started after intake of IMP) or laboratory abnormality (including blood chemistry and urinalysis) that, upon discretion of the investigator, should prohibit further treatment with study medication in this trial(a).
    2.Significant treatment non-compliance (defined as having taken <70% of study medication) or study non-compliance during the MP (as assessed by the investigator, in consultation with the medical monitor), and/or inability or unwillingness to follow instructions by study personnel.
    3.Multiple significant protocol deviations during the MP that are assessed by the investigator, in consultation with the medical monitor, to negatively affect further patient cooperation in this study.
    4.Use of experimental/investigational drug (with the exception of COVID-19 vaccines approved by emergency use authorization) and/or participation in another clinical trial of an investigational drug throughout the duration of the EP open-label treatment period.
    (a) If a TEAE(s) is the reason for exclusion from the EP open-label treatment period, the eligibility can be re-assessed up to 12 weeks following the last treatment in the MP.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first confirmed relapse, as determined by the Independent Neurology Evaluation Committee (INEC), relapse occurred after the start of treatment administration and before the end of the main period (EOMP), censored at a maximum of 72 weeks, Visit 8 (V8)/EOMP
    E.5.1.1Timepoint(s) of evaluation of this end point
    at least 2 weeks, maximum 72 weeks
    at least 2 weeks, maximum 72 weeks
    E.5.2Secondary end point(s)
    Key secondary efficacy:
    1)Changes in total volume of new T2-lesions from baseline (BL, SV2) MRI until Week 24 MRI;
    2) Time to 12-week confirmed disability worsening (12wCDW)
    as assessed on Expanded Disability Status Scale (EDSS); as
    defined in this protocol during the MP (censored until at Week 72/EOMP visit but with confirmation potentially done within EP, if applicable);
    3)Time to confirmed clinically relevant changes in Symbol Digit Modalities Test (SDMT) in the MP (censored Week 72/EOMP;
    4)Annualized rate of percentage changes in whole brain volume from BL MRI to until V8/EOMP MRI;
    Please refer to protocol for secondary efficacy, safety, and exploratory endpoints.
    Key secondary efficacy:
    1)Changes in total volume of new T2-lesions from baseline (BL, SV2) MRI
    until Week 24 MRI;
    2)Time to 12-week confirmed disability worsening (12wCDW)
    as assessed on Expanded Disability Status Scale (EDSS); as
    defined in this protocol during the MP (censored until at Week 72/EOMP
    visit but with confirmation potentially done within EP, if applicable);
    3)Time to confirmed clinically relevant changes in Symbol Digit
    Modalities Test (SDMT) in the MP (censored Week 72/EOMP;
    4)Annualized rate of percentage changes in whole brain volume from BL MRI to until V8/EOMP MRI;
    Please refer to protocol for secondary efficacy, safety, and exploratory endpoints.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to section 7 of the clinical study Protocol
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Colombia
    India
    Mexico
    United States
    Albania
    Belarus
    Georgia
    North Macedonia
    Moldova, Republic of
    Russian Federation
    Ukraine
    Bulgaria
    Greece
    Lithuania
    Poland
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS at the end of Extension study
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1050
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 206
    F.4.2.2In the whole clinical trial 1050
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the study completion subjects will continue the treatment of care as per decision of their ordinating doctor
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-12
    P. End of Trial
    P.End of Trial StatusOngoing
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