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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-000049-34
    Sponsor's Protocol Code Number:ACT16753
    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:2022-09-15
    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 ConcernedGermany - BfArM
    A.2EudraCT number2022-000049-34
    A.3Full title of the trial
    A Phase 2 double blind, randomized, placebo controlled study evaluating the effect of SAR443820 on serum neurofilament levels in participants with multiple sclerosis, followed by an open label long-term extension period
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2 study of SAR443820 in participants with multiple sclerosis (MS)
    A.4.1Sponsor's protocol code numberACT16753
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1271-1257
    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 SponsorSanofi-aventis recherche & développement
    B.1.3.4CountryFrance
    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 supportSanofi-Aventis recherche & développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-Aventis Deutschland GmbH
    B.5.2Functional name of contact point
    B.5.3.4CountryGermany
    B.5.6E-mailmedinfo.de@sanofi.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 nameSAR443820
    D.3.4Pharmaceutical form Film-coated 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.3.9.3Other descriptive nameSAR443820
    D.3.9.4EV Substance CodeSUB224044
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboFilm-coated tablet
    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
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term 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
    - Part A: To assess the effect of SAR443820 compared to placebo on serum neurofilament (sNfL)
    - Part B: To assess long-term trends in durability of sNfL
    E.2.2Secondary objectives of the trial
    - Part A: To evaluate efficacy of SAR443820 compared to placebo on imaging and clinical endpoints
    - Part A: To explore effect of SAR443820 compared to placebo on brain volume and chronic lesions
    - Part A: To assess the safety and tolerability of SAR443820
    - Part A: To assess pharmacokinetic (PK) of SAR443820
    - Part B: To explore the effect of SAR443820 on brain volume and chronic lesions
    - Part B: To assess the long-term safety and tolerability of SAR443820
    - Part B: To evaluate long-term effect of SAR443820 on disease progression and activity assessed by other clinical and imaging measures on physical function and patient reported outcomes (PROs)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female, 18 to 60 years (inclusive) of age, at the time of signing the informed consent.
    - Participants with diagnosis of RRMS, SPMS (relapsing or non-relapsing) or primary progressive subtype according to the 2017 revision of the McDonald diagnostic criteria (SPMS diagnostic criteria according to initial relapsing remitting disease course followed by progression with or without occasional relapses, minor remissions, and plateaus; progression denotes the continuous worsening of neurological impairment over at least 6 months).
    - Participants with Expanded Disability Status Scale (EDSS) score of 2-6 inclusive at screening.
    - Participants who are either untreated or in the opinion of the Investigator are stable on an allowed disease-modifying therapy (DMT) (interferons, glatiramer acetate, fumarates, or teriflunomide) for at least the past 3 months, and do not require a change in multiple sclerosis (MS) treatment for the duration of Part A and Part B (through Week 96).
    - Participants with body weight at least 45 kg and body mass index (BMI) at least 18.0 kg/m^2.
    - Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:

    Medical conditions
    - Participants with immunodeficiency syndromes or other autoimmune diseases requiring immunosuppressive therapy
    - Participants with a history of seizures or epilepsy (history of febrile seizure during childhood is allowed).
    - Participants with known clinical relapse (acute or subacute episodes of new or increasing neurological dysfunction followed by full or partial recovery, in absence of fever or infection) within 8 weeks of study enrollment.
    - Participants with neurological disease history other than MS, eg, head trauma within 3 months, cerebrovascular disease, and vascular dementia.
    - Participants with a history of recent serious infection (eg, pneumonia,septicemia) within 4 weeks of screening; an infection requiring hospitalization or intravenous antibiotics, antivirals, or antifungals within 4 weeks of screening; or chronic bacterial infections (such as tuberculosis) deemed unacceptable, as per Investigator’s judgment.
    - Participants who have significant cognitive impairment, psychiatric disease, other neurodegenerative disorders (eg, Parkinson disease or Alzheimer disease), substance abuse (including a history of alcohol abuse), or any other conditions that would make the
    participants unsuitable for participating in the study or could interfere with assessment or completing the study in the opinion of the Investigator.
    - Participants with a documented history of attempted suicide over the 24 weeks prior to the Screening Visit, presents with suicidal ideation of category 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS),or if in the Investigator's judgment, the participant is at risk for a suicide attempt.
    - Participants with a history of unstable or severe cardiac, pulmonary, oncological, hepatic, or renal disease or another medically significant illness other than MS precluding their safe participation in this study.
    - Participants who received a live vaccine within 14 days before the Screening Visit.
    - Participants with a known history of allergy to any ingredients of SAR443820 (mannitol, lactose monohydrate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and microcrystalline cellulose).

    Prior/concomitant therapy
    - Participants with a current use of any medications that are moderate or strong inhibitors or strong inducers of cytochrome P450 3A4 (CYP3A4).
    - Participants with a current use of any of the following medications/treatments: fampridine/dalfampridine, ofatumumab, fingolimod, cladribine, siponimod, ponesimod, ozanimod, alemtuzumab, mitoxantrone, ocrelizumab, natalizumab, or similar approved compounds but with different trade names and any unapproved treatments or therapies for MS; any DMTs newly approved after January 2023 that are marketed at any time during the course of the double-blind study period. These medications are not allowed within 5 half-lives before the Screening Visit and for the duration of Part A and Part B.

    Prior/concurrent clinical study experience
    - Participants who have prior/concurrent clinical study enrollment, ie, the participant has taken other investigational drugs within 4 weeks or 5 halflives, whichever is longer, before the first Screening Visit; concurrent or recent participation in non-interventional studies may be permitted.

    Diagnostic assessments
    Participants with abnormal laboratory test(s) at the Screening Visit:
    - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 3.0 x upper limit of normal (ULN)
    - Bilirubin more than 1.5 x ULN; unless the participant has documented Gilbert syndrome (isolated bilirubin more than 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%)
    - Serum albumin less than 3.5 g/dL
    - Estimated Glomerular filtration rate less than 60 mL/min/1.73 m^2 (Modification of Diet in Renal Disease [MDRD])
    - Other abnormal laboratory values or electrocardiogram (ECG) changes that are deemed clinically significant as per Investigator’s judgment
    E.5 End points
    E.5.1Primary end point(s)
    1)Part A: Week 48 sNfL levels relative to baseline
    2)Part B: Week 96 sNfL levels relative to baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    1)2)From baseline (Week 0) to Week 48
    E.5.2Secondary end point(s)
    1)Part A: Cumulative number of new gadolinium (Gd)-enhancing T1 hyperintense lesions as detected by magnetic resonance imaging (MRI)
    2)Part A: Cumulative number of new and/or enlarging T2 hyperintense lesions as detected by MRI
    3)Part A: Time to onset of 12 weeks confirmed disability progression (CDP) from baseline as assessed by the Expanded Disability Status Scale (EDSS) score
    4)Part A: Time to onset of sustained 20% increase in 9-Hole Peg Test (9-HPT) confirmed over at least 12 weeks
    5)Part A: Time to onset of sustained 20% increase in timed 25-foot walk test (T25-FW) confirmed over at least 12 weeks
    6)Part A: Change from baseline in EDSS Plus
    7)Part A: Annualized relapse rate (ARR) of RMS population (relapsing SPMS and RRMS)
    8)Part A: Percent change from baseline in brain volume loss (BVL) as detected by brain MRI
    9)Part A: Change from baseline in the volume, number, and intensity (T1) of slowly expanding lesions (SELs), and normalized T1 intensity in lesions
    10)Part A: Change from baseline in the total number and volume of non-enhancing lesions
    11)Part A: Change from baseline in the number of phase rim lesions (PRL) in sites with 3 Tesla (3T) capability
    12)Part A and Part B: Incidence of adverse event(AE), serious adverse event (SAE), treatment emergent adverse event (TEAE), potentially clinically significant abnormality (PCSA) in laboratory tests, electrocardiogram (ECG) and vital signs
    13)Part A: Plasma concentration of SAR443820
    14)Part B: Percent change from baseline in BVL as detected by brain MRI
    15)Part B: Change from baseline in volume, number and intensity (T1) in SEL and normalized T1 intensity in lesions
    16)Part B: Change from baseline in the total number and volume of non-enhancing lesions
    17)Part B: Change from baseline in the number of PRLs (same participants/centers from Part A with 3T capability)
    18)Part B: Cumulative number of new Gd enhancing lesions as detected by T1-weighted MRI
    19)Part B: number of new or enlarging T2- hyperintense lesions on MRI
    20)Part B: ARR of RMS population (relapsing SPMS and RRMS)
    21)Part B: Time to onset of composite CDP (CCDP), confirmed over at least 12 weeks (3-month CCDP), by the EDSS Plus composite(EDSS score increase, OR 20% increase in the T25-FW test, OR 20% increase in the 9-HPT)
    22)Part B: Time to onset of 12 weeks CDP as assessed by the EDSS score
    23)Part B: Time to onset of sustained 20% increase in 9-HPT confirmed over at least 12 weeks
    24)Part B: Time to onset of sustained 20% increase T25-FW test confirmed over at least 12 weeks
    25)Part B: Change from baseline in EDSS Plus
    26)Part B: Change in Multiple Sclerosis Impact Scale -29 version 2 (MSIS-29v2) physical and psychological domains scoring
    27)Part B: Change in Multiple Sclerosis Walking Scale 12 items (MSWS-12)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1)Baseline (Week 0) to Week 48
    2)Baseline (Week 0) to Week 48
    3)Up to Week 48
    4)Up to Week 48
    5)Up to Week 48
    6)From baseline (Week 0) to Week 48
    7)Up to Week 48
    8)From baseline (Week 0) to Weeks 48
    9)From baseline (Week 0) to Weeks 12, 24, 36 and 48
    10)From baseline (Week 0) to Weeks 12, 24, 36 and 48
    11)From baseline (Week 0) to Weeks 12, 24, 36 and 48
    12)Up to Week 96
    13)Up to Week 36
    14)From baseline (Week 0) to Week 96
    15)From baseline (Week 0) to Weeks 96
    16)From baseline (Week 0) to Weeks 96
    17)From baseline (Week 0) to Weeks 96
    18)Week 48 to Week 96
    19)Week 48 to Week 96
    20)Up to Week 96
    21)Up to Week 96
    22)Up to Week 96
    23)Up to Week 96
    24)Up to Week 96
    25)From baseline (Week 0) to Week 96
    26)From baseline (Week 0) to Week 96
    27)From baseline (Week 0) to Week 96
    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 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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    Chile
    Canada
    China
    Belgium
    Bulgaria
    France
    Germany
    Greece
    Italy
    Poland
    Spain
    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 years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days5
    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: 280
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 280
    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)
    None
    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 Decision2022-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-04
    P. End of Trial
    P.End of Trial StatusOngoing
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