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    Summary
    EudraCT Number:2021-003296-33
    Sponsor's Protocol Code Number:ML42302
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-12-28
    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 ConcernedGreece - EOF
    A.2EudraCT number2021-003296-33
    A.3Full title of the trial
    OPEN-LABEL MULTICENTER STUDY TO DETERMINE THE EFFECT OF OCRELIZUMAB ON LEPTOMENINGEAL INFLAMMATION IN MULTIPLE SCLEROSIS (LEGATO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OPEN-LABEL MULTICENTER STUDY TO DETERMINE THE EFFECT OF OCRELIZUMAB ON LEPTOMENINGEAL INFLAMMATION IN MULTIPLE SCLEROSIS (LEGATO)
    A.4.1Sponsor's protocol code numberML42302
    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 SponsorF. Hoffmann-La Roche Ltd.
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code3047
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenetechtrials@roche.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 Yes
    D.2.1.1.1Trade name OCREVUS
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 nameOCRELIZUMAB
    D.3.2Product code RO4964913
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrauterine use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOcrelizumab
    D.3.9.1CAS number 637334-45-3
    D.3.9.2Current sponsor codeRO4964913; PRO70769
    D.3.9.3Other descriptive nameRecombinant humanized anti-CD20 monoclonal antibody
    D.3.9.4EV Substance CodeSUB121707
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30 mg/1 ml
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active progressive multiple sclerosis
    E.1.1.1Medical condition in easily understood language
    Patients of both genders with active progressive multiple sclerosis, defined with Lublin 2013 classification
    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 20.0
    E.1.2Level HLT
    E.1.2Classification code 10052785
    E.1.2Term Multiple sclerosis acute and progressive
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063400
    E.1.2Term Secondary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067063
    E.1.2Term Progressive relapsing multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10048393
    E.1.2Term Multiple sclerosis relapse
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063401
    E.1.2Term Primary progressive multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    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
    The primary efficacy objective for this study is to determine the evolution of leptomeningeal lesions in patients with active progressive multiple sclerosis:
    •The number of LMCE foci at the Month 24 visit compared to the number of LMCE foci at the Baseline visit in the LMCE-positive group.
    The exploratory efficacy objective for this study is to investigate influence of leptomeningeal lesions evolution on brain atrophy estimates at 2 years with regard to LMCE-status:
    •Percentage of brain volume change (PBVC) after 2 years in the LMCE-positive group and the LMCE-negative group separately.
    The safety objective for this study is to evaluate the safety of ocrelizumab:
    •Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0.
    •Change from baseline in vital signs (respiratory rate, pulse rate, and systolic and diastolic blood pressure).
    •Change from baseline in laboratory test results (hematology and chemistry panel).

    E.2.2Secondary objectives of the trial
    The secondary efficacy objective for this study is to determine the evolution of leptomeningeal lesions in patients with active progressive multiple sclerosis based on the following endpoints:
    •The change from the Baseline visit in LMCE foci at the Month 12 visit in the LMCE- positive group and in the LMCE-negative group.
    •The change from the Baseline visit in LMCE foci at the Month 24 visit in the LMCE-negative group.
    •Time until 3-months composite confirmed disability progression in the LMCE-positive group and the LMCE-negative group separately.
    •Time until 3-months confirmed disability progression in the LMCE-positive group and the LMCE-negative group separately.
    •Time until 3-months confirmed 20% worsening in arm function (9-HPT) in the LMCE-positive group and the LMCE-negative group separately.
    •Time until 3-months confirmed 20% worsening of gait function (T25FWT) in the LMCE-positive group and the LMCE-negative group separately.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Signed Informed Consent Form.
    •Age ≥ 18 and ≤ 65 years at time of signing Informed Consent Form.
    •Ability to comply with the study protocol.
    •Patients of both genders with active progressive multiple sclerosis, defined with Lublin 2013 classification: primary progressive multiple sclerosis with subsequent relapses or MRI activity (McDonald 2017 criteria), secondary progressive multiple sclerosis with relapses or MRI activity during 2 years prior to initiation of ocrelizumab.
    •It is indicated to treat patients with ocrelizumab according to local regulations.
    •EDSS ≤ 6.0.
    •Readiness for blood sampling from peripheral vein puncture.
    •Neurological stability (no clinically significant worsening according to neurological examination) for ≥30 days prior to both screening and baseline.
    •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, as defined below:
    Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 6 months after the final dose of ocrelizumab.
    A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis).
    •For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:
    With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of ocrelizumab to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
    The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not adequate methods of preventing drug exposure. If required per local guidelines or regulations, information about the reliability of abstinence will be described in the local Informed Consent Form.
    E.4Principal exclusion criteria
    •Inability to provide informed consent.
    •Inability to undergo MRI due to devices or metallic foreign bodies considered unsafe in the MRI magnet (contraindications for MRI include but are not restricted to claustrophobia, weight ≥ 140 kg, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc.).
    •Known presence of other neurological disorders which may mimic MS including but not limited to: neuromeylitis optica, Lyme disease, untreated vitamin B12 deficiency, neurosarcoidosis and cerebrovascular disorders.
    •Known allergies to contrast agent.
    •Pregnant or breastfeeding, or intending to become pregnant during the study or within 6 months after the final dose of ocrelizumab.
    Women of childbearing potential must have a negative serum pregnancy test result at screening.
    •Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
    •History or currently active primary or secondary immunodeficiency.
    •Moderately to severe kidney function decreased or severe kidney failure (Glomerular filtration rate <45 mL/min/1.73 m2 as calculated through use of the Chronic Kidney Disease Epidemiology Collaboration equation).
    •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
    •Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study.
    •Congestive heart failure (NYHA III or IV functional severity).
    •Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds.
    •Infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to the Baseline visit or oral antibiotics within 2 weeks prior to the Baseline visit.
    •History or known presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV, syphilis, tuberculosis).
    •History of progressive multifocal leukoencephalopathy (PML).
    •History of malignancy, including solid tumors and hematological malignancies, except basal cell carcinoma, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix of the uterus that have been previously completely excised with documented, clear margins.
    •History of illicit drug or alcohol abuse within 24 weeks prior to screening, in the investigator’s judgment.
    •History or laboratory evidence of coagulation disorders.
    •Receipt of a live vaccine within 6 weeks prior to baseline.
    •Treatment with any investigational agent within screening period or five half-lives of the investigational drug (whichever is longer).
    •Contraindications to or intolerance of oral or intravenous corticosteroids, including methylprednisolone administered intravenously, according to the country label, including: psychosis not yet controlled by a treatment and hypersensitivity to any of the constituents.
    •Previous therapy with B-cell depleting agents (i.e. rituximab, ocrelizumab, atacicept, belimumab or ofatumumab).
    •Systemic corticosteroid therapy within 4 weeks prior to screening.
    •Any previous treatment with alemtuzumab, anti-CD4 antibodies, cladribine, mitoxantrone, daclizumab, dimethyl fumarate, teriflunomide, laquinimod, total body irradiation or bone marrow transplantation.
    •Treatment with cyclophosphamide, azathioprine, mycophenolate mofetil (MMF), cyclosporine, methotrexate or natalizumab within 24 months prior to screening.
    •Treatment with fingolimod or other S1P receptor modulator within 24 weeks prior to screening.
    •Treatment with intravenous immunoglobulin within 12 weeks prior to baseline.
    •Positive screening tests for hepatitis B (hepatitis B surface antigen [HBsAg] positive, or positive hepatitis B core antibody [total HBcAb] confirmed by a positive viral deoxyribonucleic acid [DNA] polymerase chain reaction [PCR]) or hepatitis C (HepCAb).
    •Positive syphilis (RPR) test.
    •Positive HIV infection serological test.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy objective for this study is to determine the evolution of leptomeningeal lesions in patients with active progressive multiple sclerosis (MS) based on the following endpoint:
    •The number of LMCE foci at the Month 24 visit compared to the number of LMCE foci at the Baseline visit in the LMCE-positive group.

    The first exploratory efficacy objective for this study is to investigate influence of leptomeningeal lesions evolution on brain atrophy estimates at 2 years with regard to LMCE-status based on the following endpoint:
    •Percentage of brain volume change (PBVC) after 2 years in the LMCE-positive group and the LMCE-negative group separately.

    The safety objective for this study is to evaluate the safety of ocrelizumab on the basis of the following endpoints:
    • Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0.
    • Change from baseline in vital signs (respiratory rate, pulse rate, and systolic and diastolic blood pressure).
    • Change from baseline in laboratory test results (hematology and chemistry panel).

    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 24 month, 2 years
    E.5.2Secondary end point(s)
    •The change from the Baseline visit in LMCE foci at the Month 12 visit in the LMCE- positive group.
    •The change from the Baseline visit in LMCE foci at the Month 12 visit in the LMCE-negative group.
    •The change from the Baseline visit in LMCE foci at the Month 24 visit in the LMCE-negative group.
    •Time until 3-months composite confirmed disability progression in the LMCE-positive group and the LMCE-negative group separately.
    •Time until 3-months confirmed disability progression in the LMCE-positive group and the LMCE-negative group separately.
    •Time until 3-months confirmed 20% worsening in arm function (9-HPT) in the LMCE-positive group and the LMCE-negative group separately.
    •Time until 3-months confirmed 20% worsening of gait function (T25FWT) in the LMCE-positive group and the LMCE-negative group separately.
    •B-cell repertoire at baseline in the LMCE-positive group and the LMCE-negative group separately.
    •The change in the B-cell repertoire at Month 24 compared to baseline in the LMCE-positive group and the LMCE-negative group separately.
    •The change in the B-cell repertoire at Month 24 compared to baseline in the subgroup of LMCE-positive patients with decreased amount of LMCE foci at Month 24 and subgroup of LMCE-positive patients with stable or increased amount of LMCE foci at Month 24 separately.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 3 months, 12 month, 24 month, 2 year
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    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 No
    E.8.5The trial involves multiple Member States No
    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
    Greece
    Russian Federation
    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
    The end of study is defined as the date when the last patient, last visit (LPLV) occurs or the date at which the last data point required for statistical analysis or long-term follow-up is received from the last patient, whichever occurs later. LPLV is expected to occur after 24 months after the last patient is enrolled.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    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 10
    F.4.2.2In the whole clinical trial 50
    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)
    Currently, the Sponsor does not have any plans to provide Roche IMP Ocrelizumab (RO4964913) or any other study treatments to patients who have completed the study. The Sponsor may evaluate whether to continue providing Ocrelizumab (RO4964913) in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product.
    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 Decision2022-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-17
    P. End of Trial
    P.End of Trial StatusOngoing
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