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    Summary
    EudraCT Number:2021-000048-23
    Sponsor's Protocol Code Number:P2-IMU-838-PMS
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-12
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-000048-23
    A.3Full title of the trial
    Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients with Progressive Multiple Sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test IMU-838 in patients with progressive multiple sclerosis
    A.3.2Name or abbreviated title of the trial where available
    CALLIPER Study
    A.4.1Sponsor's protocol code numberP2-IMU-838-PMS
    A.5.4Other Identifiers
    Name:IND numberNumber:156,314
    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 pointDr. Andreas Muehler, CMO
    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+49892080 477 02
    B.5.6E-mailAndreas.Muehler@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 nameIMU-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 codeIMU-838
    D.3.9.3Other descriptive nameIM90838
    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 number45
    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 nameIMU-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 codeIMU-838
    D.3.9.3Other descriptive nameIM90838
    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 number22.5
    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
    Progressive forms of Multiple Sclerosis
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis (MS)
    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 26.1
    E.1.2Level PT
    E.1.2Classification code 10053395
    E.1.2Term Progressive 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 evaluate the efficacy of IMU-838 versus placebo as measured by quantitative magnetic resonance imaging (MRI) analysis for whole brain atrophy in progressive multiple sclerosis (PMS) patients with the Structural Image Evaluation using Normalization of Atrophy (SIENA) method during the Main Treatment (MT) period
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of IMU-838 versus placebo as measured by quantitative MRI analysis for whole-brain atrophy in PMS patients with the Structural Image Evaluation using the Brain Parenchymal Fraction (BPF) method during the MT period.

    To evaluate the efficacy of IMU-838 compared to placebo in terms of disability worsening during the MT period.

    To evaluate the efficacy of IMU-838 compared to placebo in terms of disability and other clinical assessments during the MT period.

    To evaluate the efficacy of IMU-838 compared to placebo in terms of MRI parameters during the MT period.

    To evaluate the efficacy of IMU-838 compared to placebo in terms of neurofilament light chain (NfL) level.

    To evaluate the safety and tolerability of IMU-838 compared to placebo during the MT period and evaluate the long-term safety and tolerability of IMU-838 during the open-label extension (OLE) period.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult patients, age 18 to 65 years (inclusive).
    2. No evidence of relapse in the last 24 months before randomization, AND
    Patients diagnosed with either
    a) SPMS, in patients showing evidence of Gd+ MRI lesions (active SPMS) in the brain or spinal cord, or without Gd+ MRI lesions (non-active SPMS) in the last 12 months, OR
    b) PPMS
    according to 2017 revised McDonald Criteria and the 2013 revised classification of disease courses with a disease duration of the progressive disease of ≤10 years
    3. EDSS score at screening between 3.0 to 6.5 (both inclusive).
    4. Evidence of disability worsening not temporarily related to a relapse in the last 24 months before randomization, adjudicated by a central independent reviewer, and documented as:
    a) An increase of EDSS of at least 1.0 point with Screening EDSS of up to 5.5 (inclusive) and 0.5 point for Screening EDSS 6.0 or 6.5 (as documented in patient files in the last 24 months before randomization), OR
    b) A 20% worsening (or more) in 25-foot walk time or 9-hole peg test time in either hand (as documented in patient files in the last 24 months before randomization),
    OR
    c) A written summary of the clinical evidence of disability worsening in the previous 24 months before randomization through a retrospective assessment of disease worsening from patient files.
    5. Female patients:
    a) Must be of non-childbearing potential, i.e., 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 at Day 1 (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 of 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 (i.e., 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 [e.g., 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.
    6. 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
    Note: Simultaneous use of male and female condoms with or without any other contraception methods is not permitted.
    c) If they have a female partner of childbearing potential, the partner should use a highly effective contraceptive method as outlined in inclusion criterion 4.
    d) 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 by the patient before the beginning of any study-related procedure.

    For more information, please refer to Clinical Study Protocol.

    Inclusion Criteria for the OLE Period
    1. Completed 120 weeks of MT period or have confirmed 24-week disability worsening or the patient was in the MT period when the study reached the MT termination event, at which time, the patient could enter the OLE treatment period.
    E.4Principal exclusion criteria
    MS-related exclusion criteria:
    1. Any disease other than MS that may better explain the signs and symptoms, including a history of complete transverse myelitis.
    2. Clinical signs or presence of laboratory findings suggestive for neuromyelitis optica spectrum disorders (NMOSD) or myelin oligodendrocyte glycoprotein (MOG)-associated encephalomyelitis (i.e., presence of aquaporin-4 antibodies or anti-MOG antibodies).
    3. Any MRI finding, atypical for MS, including but not limited to a longitudinally extensive spinal cord lesion.
    4. Any active and uncontrolled coexisting autoimmune disease, other than MS (except for type 1 diabetes mellitus and inflammatory bowel disease).
    Therapy-related exclusion criteria:
    5. Any previous or current use of the following MS treatments:
    a) alemtuzumab or belimumab, including their biosimilars,
    b) cladribine,
    c) total lymphoid irradiation, and
    d) bone marrow or stem cell transplantation.
    6. Any use of the following MS treatments before the date of randomization (see table in study protocol)
    7. Any use of adrenocorticotrophic hormone (ACTH) or occasional use of systemic corticosteroids (oral or intravenous) 30 days before SV2.
    8. Use of any investigational product within 8 weeks or 5× the respective PK half-life before the date of informed consent, whichever is longer, and throughout the study. For some investigational products, prolonged biological effects beyond 8 weeks should be considered.

    For more information, please refer to Clinical Study Protocol.

    Exclusion Criteria for the OLE Period:
    Patients meeting any of the following criteria will be ineligible to participate in the OLE
    Period of the study:
    1. Any ongoing, clinically significant (as assessed by the Investigator) treatment-emergent AE or laboratory abnormality (including blood biochemistry and urinalysis) that can jeopardize the patient’s safety, in agreement with the medical monitor.
    2. Significant study or treatment non-compliance (<80% or >125%) during the MT period, and/or inability or unwillingness to follow instructions by study personnel.
    3. The lack of interpretable BL or EoMT MRI or the omission of more than one other MRI during the MT.
    4. Use of experimental/investigational drug (except for COVID-19 vaccines approved by emergency use authorization or similar expanded access schemes) and/or participation in another clinical study of an investigational drug throughout the duration of the OLE treatment period.
    E.5 End points
    E.5.1Primary end point(s)
    Annualized rate of percent brain volume change (PBVC) during MT period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be analyzed on the mITT analysis set. The annualized rate of PBVC between BL and EoMT (or the last available MRI) will be assessed within a random intercept, random slope mixed model, accounting for treatment effect, and stratified for the same factors for which randomization was stratified. The null hypothesis of equal mean slopes of the 2 treatment arms will be tested (at a two-sided 5% level).
    Sensitivity analyses will be performed to assess the effect of different ICE handling strategies.
    E.5.2Secondary end point(s)
    Annualized rate of change in BPF during MT period

    Time to 24-week confirmed disability worsening based on expanded disability status scale (EDSS) during the MT period
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to section 14.3.4.2. of 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 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 EEA80
    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
    North Macedonia
    Moldova, Republic of
    Ukraine
    Canada
    Russian Federation
    Serbia
    United States
    Bulgaria
    Czechia
    Finland
    Germany
    Hungary
    Netherlands
    Poland
    Romania
    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
    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 months10
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months6
    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: 420
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 30
    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 400
    F.4.2.2In the whole clinical trial 450
    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)
    At the end of the specified OLE Period in this protocol, or in case of early discontinuation of the study, patients will undergo an EoS visit at 28 days following the last dose of the study drug. No further treatment or care afterwards is planned.
    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 Decision2021-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-10
    P. End of Trial
    P.End of Trial StatusOngoing
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