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    Summary
    EudraCT Number:2018-001896-19
    Sponsor's Protocol Code Number:P2-IMU-838-MS
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-04-05
    Trial results View 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 ConcernedGermany - BfArM
    A.2EudraCT number2018-001896-19
    A.3Full title of the trial
    Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS)
    Randomisierte, doppelblinde, placebokontrollierte, multizentrische Phase-2-Studie zur Bewertung der Wirkung von IMU-838 auf die Krankheitsaktivität, gemessen mittels Magnetresonanztomographie (MRT), sowie der Sicherheit und Verträglichkeit bei Patienten mit schubförmig remittierender Multipler Sklerose (RRMS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS)
    Randomisierte, doppelblinde, placebokontrollierte, multizentrische Phase-2-Studie zur Bewertung der Wirkung von IMU-838 auf die Krankheitsaktivität, gemessen mittels Magnetresonanztomographie (MRT), sowie der Sicherheit und Verträglichkeit bei Patienten mit schubförmig remittierender Multipler Sklerose (RRMS)
    A.3.2Name or abbreviated title of the trial where available
    EMPhASIS
    A.4.1Sponsor's protocol code numberP2-IMU-838-MS
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03846219
    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 pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street AddressLochhamer Schlag 21
    B.5.3.2Town/ cityGraefelfing
    B.5.3.3Post code82166
    B.5.3.4CountryGermany
    B.5.4Telephone number+49892500 79464
    B.5.5Fax number+49892500 79466
    B.5.6E-mailandreas.muehler@immunic.de
    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-RC
    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.3.9.2Current sponsor codeIMU-838-RC
    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 Yes
    D.3.11.13.1Other medicinal product typeManufact. process of IMU-838 was amended to permit a larger batch size, mainly replacing wet granulation by roller compaction requiring slight formulation modifications. New code name is: IMU-838-RC.
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    relapsing-remitting 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 21.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting 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
    Cohort 1 (i.e. the main study):
    Primary
    • To evaluate the efficacy of 45 mg/day IMU-838 in the treatment of RRMS based on MRI assessments

    Cohort 2 (i.e. the sub-study):
    Primary
    • To obtain more efficacy and safety data of IMU-838 in patients with RRMS and to allow pharmacodynamic modelling of the dose response.
    E.2.2Secondary objectives of the trial
    Secondary
    • To evaluate the efficacy of 30 mg/day IMU-838 in the treatment of RRMS based on magnetic resonance imaging (MRI) assessments
    • To evaluate the safety and tolerability of 30 mg/day and 45 mg/day IMU-838 in RRMS patients


    Tertiary
    • To evaluate PD effects of IMU-838 in RRMS patients
    • To evaluate IMU-838 trough values and population PK
    • To evaluate the effects of IMU-838 on treatment satisfaction in patients with RRMS
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The sub-study has the same title, date and version as the main study. It is a double-blind, placebo-controlled, randomized, parallel-group sub-trial of P2-IMU-838-MS to assess the efficacy and safety of once-daily oral 10 mg/day IMU-838 compared to placebo in patients with RRMS and evidence of active disease. The objective of this sub-trial is to obtain more efficacy and safety data of IMU-838 in patients with RRMS and to allow pharmacodynamic modelling of the dose response.
    E.3Principal inclusion criteria
    Main treatment period
    1. Male or female patient (age ≥18 to 55 years, inclusive)
    2. Diagnosis of RRMS according to the revised McDonald criteria (2017)
    Note: The diagnosis of MS (including “dissemination in time”) must have been established before the patient is screened for the trial.
    3. Disease activity evidenced
    o by either at least 2 relapses in the last 24 months, or at least 1 relapse in the last 12 months before randomization (relapses must have been assessed and documented by a physician in the patient files), AND
    o ≥1 documented Gd+ MS-related brain lesion, in the last 6 months before informed consent (date of MRI examination as well as copy of MRI report or representative image has to be available and accessible as patient source data at the study site)
    4. Expanded Disability Status Scale (EDSS) score between 0 and 4.0 (inclusive) at Screening Visit 1
    5. Female patients
    o must be of non-child-bearing potential i.e. surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before Screening Visit 1) or post-menopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or
    o if of child-bearing potential, must have a negative pregnancy test at Screening Visit 1 (blood test) and before the first IMP intake (Day 0 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 trial consent and 30 days after the last intake of the of the IMP.
    Highly effective forms of birth control are those with a failure rate less than 1% per year and include:
    − oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraceptives associated with inhibition of ovulation
    − oral, injectable, or implantable progestogen-only hormonal contraceptives associated with inhibition of ovulation
    − intrauterine device or intrauterine hormone-releasing system
    − bilateral tubal occlusion
    − vasectomized partner (i.e. the patient’s male partner underwent effective surgical sterilization before the female patient entered the clinical trial and is the sole sexual partner of the female patient during the clinical trial)
    − sexual abstinence (acceptable only if it is the patient’s usual form of birth control/lifestyle choice; periodic abstinence [e.g. calendar, ovulation, symptothermal, postovulation methods] and withdrawal are no acceptable methods of contraception)
    Barrier methods of contraception include:
    − Condom
    − Occlusive cap (diaphragm or cervical/vault caps) with spermicidal gel/film/cream/suppository
    6. Male patients must agree not to father a child or to donate sperm starting at Screening Visit 1, throughout the clinical trial and for 30 days after the last intake of the IMP. Male patients must also
    o abstain from sexual intercourse with a female partner (acceptable only if it is the patient’s usual form of birth control/lifestyle choice), or
    o use adequate barrier contraception during treatment with the IMP and until at least 30 days after the last intake of the IMP, and
    o if they have a female partner of childbearing potential, the partner should use a highly effective contraceptive method as outlined in inclusion criterion 5
    o if they have a pregnant partner, they must use condoms while taking the IMP to avoid exposure of the fetus to the IMP
    7. Willingness and ability to comply with the protocol
    8. Written informed consent given prior to any trial-related procedure

    Inclusion criteria for optional extended treatment period
    1. Compleated 24 weeks of main treatment
    2. Baseline MRI, a Week 24 MRI, as well as 2 additional post-dose MRIs

    Continuation criteria for optional extended treatment period
    1. In case the initial Week 24 MRI was not evaluated at least partially assessable, availability of a repeated Week 24 MRI
    2. Week 24 MRI (initial or repeated one, if applicable) evaluated at least partially assessable
    E.4Principal exclusion criteria
    MS-related exclusion criteria
    1. Any disease other than MS that may better explain the signs and symptoms, including history of complete transverse myelitis
    2. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from these
    3. Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica (NMO) spectrum disorders or MOG-associated encephalomyelitis (i.e. presence of anti-NMO [aquaporin-4] antibodies or anti-MOG-antibodies)
    4. MS types other than RRMS
    5. Any MRI finding, atypical for MS, including but not limited to a longitudinally extensive spinal cord lesion
    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 within 30 days before Screening Visit 1 and/or during the screening period (until Day 0)
    General exclusion criteria
    32. Current or past (within 12 months of Screening Visit 1) alcohol or drug abuse
    33. Any condition that would prevent the patient from undergoing an MRI scan, including:
    o claustrophobic conditions
    o unable to receive Gd-based MRI-contrast agents due to history of hypersensitivity to Gd-based contrast agents, or severe renal insufficiency
    o presence of metallic implants incompatible with brain MRI
    34 Legal incapacity, limited legal capacity, or any other condition that makes the patient unable to understand the patient information and informed consent form
    35. Pregnant or breastfeeding
    36. An employee of an investigator or sponsor or an immediate relative of an investigator
    37. Patients institutionalized due to judicial or administrative order

    Exclusion criteria for optional extended treatment period
    1. Any ongoing, clinically significant (as assessed by the investigator) treatment-emergent (started after intake of IMP) AE or laboratory a normality (including blood chemistry and urinalysis)7
    2. Significant treatment or trial non-compliance during the main treatment period (as assessed by the investigator), and/or inability or unwillingness to follow instructions by trial personnel
    3. Treatment compliance <70% during the main treatment period
    4. Significant protocol deviations during the main treatment period that are assessed by the investigator to negatively affect further patient cooperation in this trial
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    Cohort 1 (C1): Difference between 45 mg/day IMU-838 and placebo in the cumulative number of combined unique active (CUA) MRI lesions up to Week 24
    Cohort 2 (C2): Between-treatment differences in the cumulative number of CUA MRI and Gd+ lesions up to Week 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to Week 24
    E.5.2Secondary end point(s)
    Key secondary (hierarchical testing to primary efficacy)
    Efficacy
    C1: Difference between 30 mg/day IMU-838 and placebo in the cumulative number of CUA MRI lesions up to Week 24

    Secondary
    Efficacy
    • C1: Difference between 45 mg/day IMU-838 and 30 mg/day IMU-838 in the cumulative number of CUA MRI lesions at Week 24
    • C1: Difference between 30 mg/day IMU-838 and placebo, 45 mg/day IMU-838 and placebo, and 30 mg/day and 45 mg/day IMU-838 for the following MRI parameters and C2: Between-treatment differences in the following MRI parameters:
    o C1+C2: Mean number of CUA lesions per patient per scan at Weeks 6, 12, 18 and 24
    o C1: Cumulative number of CUA MRI lesions up to Weeks 6, 12, and 18
    o C2: Cumulative number of CUA MRI lesions up to Weeks 6, 12, 18, and 24
    o C1: Volume changes of T2 lesions at Weeks 6, 12, 18 and 24 compared to Baseline
    o C1+C2: T2-lesion load at Weeks 6, 12, 18 and 24 compared to Baseline
    o C1+C2: T1-lesion load at Weeks 6, 12, 18 and 24 compared to Baseline
    o C1+C2: Cumulative number of new Gd+ lesions up to Weeks 6, 12, 18 and 24
    o C1+C2: Cumulative number of new T2 lesions up to Weeks 6, 12, 18 and 24
    o C1+C2: Cumulative number of new T1 lesions up to Weeks 6, 12, 18 and 24
    o C1+C2: Proportion of patients without new Gd+ lesions over 24 weeks
    o C1+C2: Proportion of patients without new or enlarging T2-weighted lesions over 24 weeks
    o C1: Proportion of patients with CUA lesions at Week 24
    o C1: Proportion of patients with Gd+ lesions at Week 24
    o C1: Proportion of patients with T2 lesions at Week 24

    • C1: Differences between individual treatments and between the pooled 30 mg/day and 45 mg/day groups and placebo in the following relapse-related clinical endpoints:
    o Mean annualized relapse rate (during main and extended treatment period)
    o Proportion of relapse-free patients up to Week 24 and at extended periods thereafter
    o Time to relapse at time of final analysis of main part
    • C2: Number of relapses in each treatment arm

    • C1: Differences between treatments in changes of disease activity as measured by the following clinical parameters:
    o Mean change in the EDSS as compared to Baseline during the main and extended period (every 12 weeks starting at Week 12)
    o Proportion of patients with EDSS progression during the main and extended period (every 12 weeks starting at Week 12, and cumulatively)
    • C2: Change of EDSS from Baseline to Weeks 12 and 24
    • C1: Correlation of MRI-based assessments with quartiles of IMU-838 trough levels at Week 6 and Week 24
    • C2: Correlation of MRI-based assessments with quartiles of IMU-838 trough levels at Week 24

    Safety
    • C1+C2: AEs, serious AEs and clinically significant laboratory abnormalities (as assessed by the investigator)
    • C1+C2: AEs of special interest:
    o Red blood cell urine positive, at least of moderate intensity
    o Hematuria
    o Retroperitoneal colicky pain with suspected or confirmed nephrolithiasis
    • C1: Proportion of patients treated with 30 mg/day or 45 mg/day IMU 838 as compared to placebo who experienced at least one of the following AEs / C2: Proportion of patients treated with 10 mg/day as compared to placebo who experienced at least one of the following AEs:
    o Neutropenia
    o Lymphopenia
    o Diarrhea
    o Alopecia
    o Hemorrhage
    o Abnormalities in alanine aminotransferase, aspartate aminotransferase, gamma glutamyl transferase, and total bilirubin with both elevations > 1.5 x ULN and ≥ 35% elevated compared to Baseline
    • ECG, physical examination, and vital signs
    • C1: Micro ribonucleic acid-122 expression (Change from Baseline to 4 hours after first dose)
    • C1: Presence of John Cunningham virus (JCV) deoxyribonucleic acid (DNA) in urine in patients with detectable JCV-DNA in urine at Screening Visit 1, at Week 24, and at EoS
    • C1+C2: Time to treatment discontinuation for any reason
    • C1+C2: Rate of treatment discontinuations up to Week 24

    Pharmacokinetics
    • C1+C2: Population PK at Week 6 (3-10 hours post-dose)
    • C1+C2: Plasma trough levels of IMU-838 at Days 7 and Weeks 6, 12, 18, and 24

    Pharmacodynamics
    • C1: Changes from Baseline in lymphocyte subset parameters as measured by flow cytometry at Weeks 6 and 24 (in selected Biomarker Centers only)
    • C1: Changes from Baseline in biased T-cell clonal repertoire based on T-cell receptor deep sequencing at Weeks 6 and 24 (in selected Biomarker Centers only)
    • C1+C2: Changes from Baseline in serum neurofilament at Week 24
    • C2: Changes in serum C4 (7α-hydroxy-4-cholesten-3-one)
    • C2: Changes in serum fibroblast growth factor 19 (FGF-19)

    Health outcome (C1)
    • Treatment Satisfaction Questionnaire for Medication at Week 6, Week 24 and EoS
    E.5.2.1Timepoint(s) of evaluation of this end point
    Key secondary (hierarchical testing to primary efficacy)
    Efficacy: up to Week 24

    Secondary
    Efficacy: Baseline, Weeks 6, 12, 18 and 24
    Safety: Screening, throughout Main and Extended Treatment Period, all Unscheduled Visits and EoS
    Pharmacokinetics: Days 7 and Weeks 6, 12, 18, and 24
    Pharmacodynamics: Baseline, Weeks 6 and 24
    Health outcome: Week 6, Week 24 and EoS
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Ukraine
    Bulgaria
    Germany
    Poland
    Romania
    E.8.7Trial has a data monitoring committee No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years10
    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: 270
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 270
    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)
    According to the physician’s discretion.
    Patients in the extended treatment period may be transferred to a separate long-term follow-up trial or to commercial vidofludimus calcium (if applicable and patients have access) as per protocol section 12.8.
    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 Decision2022-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-06
    P. End of Trial
    P.End of Trial StatusOngoing
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