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    Summary
    EudraCT Number:2020-005448-48
    Sponsor's Protocol Code Number:CN42097
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-05
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2020-005448-48
    A.3Full title of the trial
    A PHASE III, NON-INFERIORITY, RANDOMIZED, OPEN-LABEL, PARALLEL GROUP, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND RADIOLOGICAL AND CLINICAL EFFECTS OF SUBCUTANEOUS OCRELIZUMAB VERSUS INTRAVENOUS OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS
    RANDOMIZOVANÉ, OTEVŘENÉ, MULTICENTRICKÉ KLINICKÉ HODNOCENÍ NON-INFERIORITY, S PARALELNÍMI SKUPINAMI, FÁZE III, ZKOUMAJÍCÍ FARMAKOKINETIKU, FARMAKODYNAMIKU, BEZPEČNOST, RADIOLOGICKÉ A KLINICKÉ ÚČINKY OCRELIZUMABU PODÁVANÉHO SUBKUTÁNNĚ OPROTI OCRELIZUMABU PODÁVANÉMU INTRAVENÓZNĚ U PACIENTŮ S ROZTROUŠENOU SKLERÓZOU
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Radiological and Clinical Effects of Subcutaneous (SC) Ocrelizumab versus Intravenous (IV) Ocrelizumab in Patients with Multiple Sclerosis
    KLINICKÉ HODNOCENÍ ZKOUMAJÍCÍ FARMAKOKINETIKU, FARMAKODYNAMIKU, BEZPEČNOST, RADIOLOGICKÉ A KLINICKÉ ÚČINKY OCRELIZUMABU PODÁVANÉHO SUBKUTÁNNĚ OPROTI OCRELIZUMABU PODÁVANÉMU INTRAVENÓZNĚ U PACIENTŮ S ROZTROUŠENOU SKLERÓZOU
    A.4.1Sponsor's protocol code numberCN42097
    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. Hoffman-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 code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@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 AuthorisationEuropean Union
    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 injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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
    D.3.9.3Other descriptive nameOCRELIZUMAB
    D.3.9.4EV Substance CodeSUB121707
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    D.3.11.13.1Other medicinal product typehumanized monoclonal antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 AuthorisationEuropean Union
    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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    D.3.9.3Other descriptive nameOCRELIZUMAB
    D.3.9.4EV Substance CodeSUB121707
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Yes
    D.3.11.13.1Other medicinal product typehumanized monoclonal antibody
    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
    Multiple Sclerosis (MS)
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis is a long-term disease that attacks the central nervous system, affecting the brain, spinal cord, and optic nerves.
    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 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
    • To demonstrate pharmacokinetics (PK) non-inferiority of the SC formulation of ocrelizumab in patients with MS
    E.2.2Secondary objectives of the trial
    • To determine the maximum serum concentration (Cmax) of ocrelizumab SC in patients with MS
    • To evaluate the radiological effects of ocrelizumab SC compared with ocrelizumab IV in patients with MS
    • To evaluate and compare the safety profile after administration of ocrelizumab SC versus ocrelizumab IV and to assess the safety of ocrelizumab SC at the selected dose in patients with MS
    • To evaluate the immune response to ocrelizumab SC and IV, and rHuPH0
    • To evaluate the effect of ocrelizumab SC compared with IV ocrelizumab on the pharmacodynamics (PD) marker for the mechanism of action of ocrelizumab (i.e. B cell depletion)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosis of primary progressive multiple sclerosis (PPMS) or relapsing multiple sclerosis (RMS) according to the revised McDonald 2017 criteria
    • Age 18-65 years, inclusive, at time of signing Informed Consent Form
    • Ability to comply with the study protocol and schedule of protocol assessments, in the investigator's judgment
    • Expanded disability status scale (EDSS) score, 0-6.5, inclusive, at screening.
    • Neurological stability for >=30 days prior to both screening and baseline
    • Disease duration from onset of MS symptoms of less than 15 years for patients with EDSS score <2.0 at screening
    • Women of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 6 months or 12 months (as applicable by the ocrelizumab IV [Ocrevus] local label) after the final dose of ocrelizumab
    • Female patients without reproductive potential may be enrolled if post-menopausal unless the patient is receiving a hormonal therapy for her menopause or if surgically sterile (i.e., hysterectomy, complete bilateral oophorectomy)
    E.4Principal exclusion criteria
    • Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV anti-microbials within 8 weeks prior to and during screening or treatment with oral anti microbials within 2 weeks prior to and during screening
    • History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
    • History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
    • Immunocompromised state
    • Receipt of a live attenuated vaccine within 6 weeks prior to randomization
    • Inability to complete an MRI or contraindication to gadolinium administration
    • Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines) for infusion-related reaction (IRRs), including closed angle glaucoma for antihistamines
    • Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study
    • Any concomitant disease that may require chronic treatment with systemic corticosteroids (e.g., mineralocorticoids and glucocorticoids) or immunosuppressants during the course of the study
    • Significant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude patient from participating in the study
    • History of or currently active primary or secondary (non-drug related) immunodeficiency
    • Pregnant or breastfeeding or intending to become pregnant during the study and 6 or 12 months (as applicable by the ocrelizumab [Ocrevus] local label) after last administration of the study drug.
    • Lack of peripheral venous access
    • History of alcohol or other drug abuse within 12 months prior to screening
    • Treatment with any investigational agent within 24 weeks prior to screening or 5 half-lives of the investigational drug (whichever is longer), or treatment with any experimental procedure for MS
    • Patients who have previously received anti-CD20s (including ocrelizumab) if the last treatment was less than 2 years before screening, and/or if B-cell count is below lower limit of normal, and/or the discontinuation of the treatment was due to safety reasons or lack of efficacy
    • Previous treatment with cladribine, atacicept, and alemtuzumab
    • Previous treatment with fingolimod, siponimod, ponesimod, or ozanimod within 6 weeks of baseline
    • Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline
    • Previous treatment with natalizumab within 4.5 months of baseline
    • Treatment with mitoxantrone within 2 years prior to baseline visit or evidence of cardiotoxicity following mitoxantrone use or a cumulative lifetime dose of more than 60 milligrams per meter square (mg/m^2)
    • Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label
    • If the washout requirements are not described in the applicable local label, then the wash out period must be 5 times the half-life of the medication. The PD effects of the previous medication must also be considered when determining the required time for washout
    • Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
    • Any previous history of transplantation or anti-rejection therapy
    • Treatment with IV immunoglobulin (Ig) or plasmapheresis within 12 weeks prior to randomization
    • Systemic corticosteroid therapy within 4 weeks prior to screening
    • Positive screening tests for active, latent, or inadequately treated hepatitis B
    • Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
    • Any additional exclusionary criterion as per ocrelizumab (Ocrevus®) local label, if more stringent than the above
    E.5 End points
    E.5.1Primary end point(s)
    1. Serum ocrelizumab area under the concentration-time curve (AUC[w1-12]) after SC administration compared to IV infusion from Day 1 to Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At Week 1 (Days 1, 2, 3, 5, 7, and 10), Weeks 2, 4, 8 and 12
    E.5.2Secondary end point(s)
    1. Maximum serum concentration (Cmax) of ocrelizumab SC in patients with MS
    2. Total number of T1Gd+ lesions as detected by brain magnetic resonance imaging (MRI) at Weeks 8 and 24
    3. Total number of new or enlarging T2 lesions as detected by brain MRI at Weeks 12 and 24 relative to the previous scan
    4. Incidence and severity of adverse events, with severity determined according to the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0
    5. Change from baseline in targeted vital signs
    6. Change from baseline in targeted clinical laboratory test results
    7. Incidence of treatment-emergent antidrug antibodies (ADAs) to ocrelizumab after SC or IV administration relative to the presence of ADAs at baseline
    8. Relationship between ADA status to ocrelizumab and pharmacokinetics, pharmacodynamics, and safety
    9. Incidence of treatment-emergent antibodies to rHuPH20 after SC administration relative to the presence at baseline
    10. Relationships between antibodies to rHuPH20 and safety
    11. Percentage of patients achieving CD19+ B cell level <5 cells/microliter at Weeks 12 and 24
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At Weeks 1, 2, 4, 8, 12, 16, 24 and 48
    2. At Weeks 8 and 24
    3. At Weeks 12 and 24
    4. Up to approximately 48 Weeks
    5. Baseline (Day 1), Weeks 2, 12, 24, 48 and safety follow up visit (every 24 weeks until 28 weeks after the last dose)
    6. Baseline (Day 1), Weeks 12, 22, 46 and safety follow up visit (every 24 weeks until 28 weeks after the last dose)
    7-10. Baseline (Day 1), Weeks 24, 48 and safety follow up visit (every 24 weeks until 28 weeks after the last dose)
    11. At Weeks 12 and 24
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    immunogenicity, radiological and clinical effects of SC administration.
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ocrelizumab, Concentrate for Solution for Infusion, 300mg
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Australia
    Brazil
    Canada
    New Zealand
    United States
    France
    Spain
    Czechia
    Italy
    Russian Federation
    Turkey
    Ukraine
    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 years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 232
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 232
    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)
    Protocol Section 4.3.4: The Roche Global Policy on Continued Access to Investigational Medicinal Product is available at the following website:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    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 Decision2022-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-19
    P. End of Trial
    P.End of Trial StatusOngoing
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