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    Summary
    EudraCT Number:2017-004703-51
    Sponsor's Protocol Code Number:COMB157G2399
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-09-27
    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 - PEI
    A.2EudraCT number2017-004703-51
    A.3Full title of the trial
    An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis
    A.4.1Sponsor's protocol code numberCOMB157G2399
    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 SponsorNovartis Pharma AG
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointMedizinischer Infoservice (MCC)
    B.5.3 Address:
    B.5.3.1Street AddressRoonstrasse 25
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90429
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 911 273-12100 
    B.5.5Fax number+49 911 27312160
    B.5.6E-mailinfoservice.novartis@novartis.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 Arzerra
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameofatumumab
    D.3.2Product code OMB157
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNOFATUMUMAB
    D.3.9.1CAS number 679818-59-8
    D.3.9.4EV Substance CodeSUB25221
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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.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 Yes
    D.2.1.1.1Trade name Kesimpta
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Ireland Limited
    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 nameOfatumumab
    D.3.2Product code OMB157
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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 INNOfatumumab
    D.3.9.1CAS number 679818-59-8
    D.3.9.4EV Substance CodeSUB25221
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous 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 20.0
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the long-term safety and tolerability of ofatumumab 20 mg sc once every 4 weeks in subjects with relapsing MS from the first dose of ofatumumab
    E.2.2Secondary objectives of the trial
    1. Describe long-term efficacy of ofatumumab 20 mg sc once every 4 weeks in subjects with relapsing MS (RMS) from the first dose of ofatumumab

    2. For subjects originally in COMB157G2301 and COMB157G2302 compare long-term outcomes in those who were immediately treated with ofatumumab versus delayed use of ofatumumab (i.e. after teriflunomide treatment in the COMB157G2301 and COMB157G2302 studies), by analyzing subjects according to their randomized treatment in COMB157G2301 and COMB157G2302

    3. For subjects randomized to teriflunomide in COMB157G2301 and COMB157G2302 and switched to ofatumumab in the COMB157G2399 compare both periods before and after the switch to ofatumumab

    4. Explore the long-term health outcomes in subjects with RMS treated with ofatumumab 20 mg sc once every 4 weeks from the first dose of ofatumumab
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. COMB157G2399 Vaccination Sub-study

    A sub-study to evaluate the effects of ofatumumab subcutaneous treatment on the immune responses following vaccination in patients with relapsing forms of multiple sclerosis.

    Version number: 02 (Amended Post-text Supplement 01), 21-Apr-2022.

    Primary objective: To characterize the humoral immune response to the tetanus-toxoid (TT) vaccine in subjects with RMS who are treated with ofatumumab 20 mg sc once every 4 weeks.

    2. COMB157G2399 COVID-19 Sub-study

    A sub-study to explore the immune response following Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination in a subset of subjects on long-term ofatumumab 20 mg sc.

    Version number: Updated in main Clinical Trial Protocol v03, 13-Apr- 2023.

    Primary objective: To explore to what extent subjects with RMS, treated with ofatumumab 20 mg sc once every 4 weeks, are able to generate a humoral response following an initial dose of a SARS-CoV-2 vaccination.
    E.3Principal inclusion criteria
    Subjects eligible for inclusion in this study must fulfill all of the following criteria:
    1. Must have participated in a Novartis MS study:
    • which dosed ofatumumab 20 mg sc every 4 weeks,
    • was an adult (≥ 18 years of age) study in RMS,
    • must have completed the study on study treatment (subjects that are on temporary drug interruption at the time of End of Study are considered completers).
    2. Written informed consent must be obtained before any assessment is performed

    Please see protocol for complete detailed list of inclusion criteria.
    E.4Principal exclusion criteria
    • Premature discontinuation from previous ofatumumab study or from
    study treatment in previous ofatumumab study
    • Subjects that have had their previous ofatumumab study EOS > 6
    months prior to screening and/or been given another MS DMT between
    EOS of previous study and screening of this study
    • Less than 3.5-month washout of teriflunomide for subjects that will
    not complete the accelerated elimination procedure (AEP) prior to Day 1.
    Only applicable to subjects completing studies COMB157G2301 and
    COMB157G2302
    .• Subjects with a history of not being able or willing to cooperate or
    comply with study protocol requirements in the opinion of the
    Investigator
    • Subjects that have any unresolved adverse event or condition from the
    previous study or prior to Day 1 that necessitates temporary interruption
    of the study treatment, until such time as the event or condition has
    resolved (the subject will be monitored within the safety follow-up of
    the previous study and not consented into study COMB157G2399 until
    the AE or condition has resolved)
    • Emergence of any clinically significant condition/disease during
    previous ofatumumab study or prior to Day 1 in which study
    participation might result in safety risk for subjects
    • Subjects with neurological findings consistent with PML or confirmed
    PML
    • Subjects with active systemic bacterial, viral or fungal infections, or
    chronic infection (e.g. Acquired Immune Deficiency Syndrome (AIDS))
    prior to Day 1
    • Subjects that have developed or have had reactivation of syphilis,
    hepatitis B or tuberculosis during previous ofatumumab study or prior to
    Day 1
    • Subjects with severe hypoproteinemia e.g. nephrotic syndrome
    • Any of the following abnormal laboratory values prior to Day 1:
    - Total or conjugated bilirubin (BIL) greater than 1.5 times the upper
    limit of normal (ULN) range, unless in the context of Gilbert's syndrome
    - Alkaline phosphatase (ALP) greater than 2 times the ULN range
    - Alanine aminotransferase (ALT)/aspartate aminotransferase (AST)
    greater than 3 times ULN
    - Any other clinically significant laboratory assessment as determined by
    the Investigator (e.g. significant anemia, neutropenia,
    thrombocytopenia, signs of impaired bone marrow function)

    Please see protocol for complete detailed list of inclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of subjects with adverse events
    • Proportion of subjects with laboratory, vital signs, or electrocardiogram (ECG) results meeting abnormal criteria
    • Proportion of subjects meeting predefined criteria in Columbia Suicide Severity Rating Scale (C-SSRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 years after LPFV
    E.5.2Secondary end point(s)
    • Annualized Relapse Rate (ARR)
    • Time to first relapse
    • Time to 3-month Confirmed Disability Worsening (3mCDW)
    • Time to 6-month Confirmed Disability Worsening (6mCDW)
    • Time to 6-month Confirmed Disability Improvement (6mCDI)
    • Time to 12-month Confirmed Disability Improvement (12mCDI)
    • Time to 24-month Confirmed Disability Improvement (24mCDI)
    • Time to 6-month Confirmed Disability Improvement (6mCDI) sustained until End of Study (EOS)
    • Change in Expanded Disability Status Scale (EDSS)
    • Time to 6-month confirmed 4-point worsening on Symbol Digit Modalities Test (SDMT)
    • Change in SDMT
    • Annualized T2 lesion rate
    • Number of T1 Gd-enhancing lesions per Magnetic Resonance Image (MRI) scan
    • Annual rate of change in brain volume
    • Change in NfL concentration in serum
    • Relationship between NFL and disease activity, disease course and treatment response
    • Patient Reported Outcomes (PRO)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 5 years
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 trial1
    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 concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA154
    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
    Argentina
    Australia
    Canada
    India
    Israel
    Japan
    Mexico
    Peru
    South Africa
    Thailand
    United States
    Switzerland
    Russian Federation
    Turkey
    Austria
    Belgium
    Bulgaria
    Croatia
    Czechia
    Denmark
    Estonia
    Finland
    France
    Germany
    Greece
    Hungary
    Italy
    Latvia
    Lithuania
    Netherlands
    Norway
    Poland
    Portugal
    Slovakia
    Spain
    Sweden
    Taiwan
    United Kingdom
    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
    Study completion is defined as when the last subject finishes his or her
    End of Study visit for the Open-Label Treatment part of the study and
    any repeat assessments associated with this End of Study visit have
    been documented and followed-up appropriately by the Investigator,
    as well as finishes his or her End of Safety Follow up visit as relevant,
    or in the event of an early study termination decision, the date of that
    decision.
    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 months9
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days15
    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: 2040
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1109
    F.4.2.2In the whole clinical trial 2040
    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)
    The investigator must provide follow-up medical care for all patients who are prematurely discontinued from the study, or must refer them back to their referring physician for appropriate care.
    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 Decision2018-10-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-10
    P. End of Trial
    P.End of Trial StatusOngoing
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