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    The EU Clinical Trials Register currently displays   42782   clinical trials with a EudraCT protocol, of which   7047   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-004719-10
    Sponsor's Protocol Code Number:AC-058B303
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-07-04
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-004719-10
    A.3Full title of the trial
    Multicenter, non-comparative extension to study AC-058B301, to investigate the long-term safety, tolerability, and control of disease of ponesimod 20 mg in subjects with relapsing multiple sclerosis
    Estudio de extensión del ensayo AC-058B301, multicéntrico, no comparativo, para valorar la seguridad, tolerabilidad y control de la enfermedad a largo plazo de ponesimod 20 mg en sujetos con esclerosis múltiple recidivante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to look at the long term benefits and risks of ponesimod 20 mg treatment for patients with relapsing multiple sclerosis.
    Estudio de investigación para analizar los beneficios y riesgos a largo plazo del tratamiento con ponesimod 20 mg para pacientes con esclerosis múltiple recurrente.
    A.3.2Name or abbreviated title of the trial where available
    OPTIMUM LT
    OPTIMUM LT
    A.4.1Sponsor's protocol code numberAC-058B303
    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 SponsorActelion Pharmaceuticals 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 supportActelion Pharmaceuticals Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationActelion Pharmaceuticals Ltd.
    B.5.2Functional name of contact pointclinical trial disclosure desk
    B.5.3 Address:
    B.5.3.1Street AddressGewerbestrasse 16
    B.5.3.2Town/ cityAllschwil
    B.5.3.3Post code4123
    B.5.3.4CountrySwitzerland
    B.5.6E-mailclinical-trials-disclosure@actelion.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 namePonesimod
    D.3.2Product code ACT-128800
    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.3.8INN - Proposed INNPONESIMOD
    D.3.9.2Current sponsor codeACT-128800
    D.3.9.4EV Substance CodeSUB182605
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 namePonesimod
    D.3.2Product code ACT-128800
    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.3.8INN - Proposed INNPONESIMOD
    D.3.9.2Current sponsor codeACT-128800
    D.3.9.4EV Substance CodeSUB182605
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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: 3
    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 namePonesimod
    D.3.2Product code ACT-128800
    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.3.8INN - Proposed INNPONESIMOD
    D.3.9.2Current sponsor codeACT-128800
    D.3.9.4EV Substance CodeSUB182605
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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: 4
    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 namePonesimod
    D.3.2Product code ACT-128800
    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.3.8INN - Proposed INNPONESIMOD
    D.3.9.2Current sponsor codeACT-128800
    D.3.9.4EV Substance CodeSUB182605
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 5
    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 namePonesimod
    D.3.2Product code ACT-128800
    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.3.8INN - Proposed INNPONESIMOD
    D.3.9.2Current sponsor codeACT-128800
    D.3.9.4EV Substance CodeSUB182605
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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: 6
    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 namePonesimod
    D.3.2Product code ACT-128800
    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.3.8INN - Proposed INNPONESIMOD
    D.3.9.2Current sponsor codeACT-128800
    D.3.9.4EV Substance CodeSUB182605
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7
    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: 7
    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 namePonesimod
    D.3.2Product code ACT-128800
    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.3.8INN - Proposed INNPONESIMOD
    D.3.9.2Current sponsor codeACT-128800
    D.3.9.4EV Substance CodeSUB182605
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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: 8
    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 namePonesimod
    D.3.2Product code ACT-128800
    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.3.8INN - Proposed INNPONESIMOD
    D.3.9.2Current sponsor codeACT-128800
    D.3.9.4EV Substance CodeSUB182605
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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: 9
    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 namePonesimod
    D.3.2Product code ACT-128800
    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.3.8INN - Proposed INNPONESIMOD
    D.3.9.2Current sponsor codeACT-128800
    D.3.9.4EV Substance CodeSUB182605
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 10
    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 namePonesimod
    D.3.2Product code ACT-128800
    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.3.8INN - Proposed INNPONESIMOD
    D.3.9.2Current sponsor codeACT-128800
    D.3.9.4EV Substance CodeSUB182605
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    relapsing multiple sclerosis
    esclerosis múltiple recidivante
    E.1.1.1Medical condition in easily understood language
    chronic inflammatory disease attacking the central nervous system, characterized by attacks on neurological function.
    Enfermedad inflamatoria crónica que ataca el sistema nervioso central, caracterizada por ataques a la función neurológic.
    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 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting 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
    Safety objectives:
    - To describe the long-term safety and tolerability of ponesimod 20 mg in subjects with RMS.
    - To describe the effects of re-initiation of ponesimod treatment after interruption in subjects with RMS.

    Efficacy objectives:
    - To describe the long term disease control in subjects with RMS receiving ponesimod 20 mg.
    - To describe the effect of a switch from teriflunomide to ponesimod 20 mg on disease control in subjects with RMS.
    Objetivos de seguridad:
    - Describir la seguridad y tolerabilidad a largo plazo de ponesimod 20 mg en sujetos con esclerosis múltiple recidivante (EMR).
    - Describir los efectos del reinicio del tratamiento con ponesimod después de su interrupción en sujetos con EMR.

    Objetivos de eficacia:
    - Describir el control de la enfermedad a largo plazo en sujetos con EMR que reciben ponesimod 20 mg.
    - Describir el efecto del cambio de teriflunomida a ponesimod 20 mg en el control de la enfermedad en sujetos con EMR.
    E.2.2Secondary objectives of the trial
    NA
    N/A
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pulmonary function monitoring:
    A sub-study assessing the diffusing capacity of the lungs, measured using carbon monoxide (DLco), will be continued in these subjects who participated in the sub-study in the core study and will be opened for participation at additionally selected sites, with appropriate equipment and experience.
    Supervisión de la función pulmonar:
    Un subestudio que evalúa la capacidad de difusión de los pulmones, medida con monóxido de carbono (DLCO), continuará en los sujetos que participaron en el subestudio del estudio principal y se abrirá para la participación en otros centros seleccionados que cuenten con los equipos y la experiencia necesarios.
    E.3Principal inclusion criteria
    1. Signed informed consent, prior to initiation of any study-mandated procedure.
    2. Subjects with MS having completed the double-blind treatment in the core study as scheduled (i.e., who completed the double-blind treatment period until Week 108).
    3. Compliance with teriflunomide elimination procedure assessed as sufficient by the investigator at visit FU1 or abbreviated visit FU2 of the core study, whichever occurred last.
    4. For subjects of reproductive potential:
    - Women of childbearing potential (WOCBP):
    - must have a negative pre-treatment urine pregnancy test on Day 1;
    - must agree to undertake 4-weekly urine pregnancy tests during the study and until 6 weeks after the first of two consecutive tests showing
    teriflunomide plasma level < 0.02 mg/L and until at least 30 days after study treatment discontinuation;
    - must have been using reliable methods of contraception uninterrupted since EOT in the core study and must agree to continue using reliable
    methods of contraception throughout the study until 6 weeks after the first of two consecutive tests showing teriflunomide plasma level
    < 0.02 mg/L and until at least 30 days after discontinuation of study treatment.

    - Fertile male subjects participating in the study who are sexually active with WOCBP must agree to use a condom until 6 weeks after the first of
    two consecutive tests confirming plasma teriflunomide level <0.02 mg/L.
    1. Firma del consentimiento informado antes del inicio de cualquier procedimiento exigido por el estudio.
    2. Sujetos con EM que hayan finalizado el tratamiento doble ciego del estudio principal según lo programado (es decir, que hayan finalizado el período de tratamiento doble ciego hasta la semana 108).
    3. Cumplimiento del procedimiento de eliminación de teriflunomida que el investigador considere suficiente en la visita SG1 o la visita abreviada SG2 del estudio principal, lo que ocurriera después.
    4. En los sujetos con potencial reproductivo:
    Mujeres con capacidad de concebir (MCC):
     - deben obtener una prueba de embarazo en orina negativa antes del tratamiento el día 1;
     - deben acceder a hacerse una prueba de embarazo en orina cada 4 semanas durante el estudio y hasta 6 semanas después de la primera
    de dos pruebas consecutivas que revelen un nivel de teriflunomida en plasma <0,02 mg/l y hasta al menos 30 días después de la
    suspensión del tratamiento del estudio;
     - deben haber usado métodos anticonceptivos fiables sin interrupción desde el FDT del estudio principal y acceder a seguir usándolos
    durante la totalidad del estudio hasta 6 semanas después de la primera de dos pruebas consecutivas que revelen un nivel de
    teriflunomida en plasma <0,02 mg/l y hasta al menos 30 días después de la suspensión del tratamiento del estudio.

    Los sujetos varones fértiles que participen en el estudio y sean sexualmente activos con MCC deben acceder a usar preservativo hasta 6 semanas después de la primera de dos pruebas consecutivas que confirmen un nivel de teriflunomida en plasma <0,02 mg/l.

    La definición de MCC y de sujetos varones fértiles y los métodos anticonceptivos aceptables en este estudio se describen en la sección 4.4. del protocolo.
    E.4Principal exclusion criteria
    1. Any of the following cardiovascular conditions on Day 1 pre-dose:
    a. Resting heart rate (HR) < 50 bpm as measured by the pre-dose 12-lead ECG;
    b. Presence of second degree atrioventricular (AV) block or third degree AV block or a QTcF interval > 470 ms (females), > 450 ms (males) on pre-
    dose 12-lead ECG;
    2. Any of the following alerts from central laboratory at Visit 14 of the core study (EOT) which was confirmed as an alert at repeated testing or not repeated prior to FU1 of the core study:
    a. Lymphocyte count: < 0.2 x 109/L (<200/mm3 blinded results);
    b. Neutrophil count <1.0 × 109/L(< 1000 cells/mm3);
    c. Platelet count < 50 × 109/L (< 50 000 cells/mm3);
    d. Creatinine clearance < 30 mL/min (Cockroft-GaultAny findings below)
    3. At Visit 14 of the core study (EOT) >30% decrease from core study baseline FEV1 and/or FVC;
    4. Clinically significant, persistent respiratory AEs (e.g., dyspnea) not resolved prior to first dosing in the extension study.
    5. Macular edema at any time between Visit 1 (Screening) in the core study and Day 1 of the extension study.
    6. Presence of the following at core study Visit 14 (EOT, Week 108), FU1, or abbreviated visit FU2, or on Day 1 of the extension study pre-dose:
    a. Suspected opportunistic infection of the CNS or any other infection which, in the opinion of the investigator, contraindicates re-start of the study
    drug;
    b. Stevens-Johnson syndrome or toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms.
    7. Need for and intention to administer forbidden studytreatment-concomitant therapy
    8. Women who are pregnant or lactating.
    9. Male subjects wishing to parent a child any time before the
    6 week period following the first of two consecutive tests confirming plasma teriflunomide level <0.02 mg/L;
    10. Treatment with any MS Disease Modifying Therapies (DMTs) between core study EOT and first dosing in extension study;
    11. Any other clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the subject at risk by participating in the study;
    12. Subjects unlikely to comply with the extension study protocol based on investigator best judgment from the core study protocol , e.g., uncooperative attitude, inability to return for follow-up visits, or known likelihood of not completing the extension study.
    1. Cualquiera de las siguientes condiciones cardiovasculares el día 1 antes de la dosis:
    a. Frecuencia cardíaca en reposo <50 latidos por minuto determinada mediante el electrocardiograma (ECG) de 12 derivaciones anterior a la dosis;
    b. Presencia de bloqueo auriculoventricular (AV) de segundo grado, bloqueo AV de tercer grado o intervalo QT corregido según la fórmula de Federicia >470 ms (mujeres) o >450 ms (hombres) en el ECG de 12 derivaciones anterior a la dosis.
    2. Cualquiera de las siguientes alertas del laboratorio central en la visita 14 del estudio principal (FDT) que se confirmó en pruebas repetidas o no repetidas antes del SG1 del estudio principal:
    a. Cifra de linfocitos: <0,2 × 109/l (<200/mm3 resultados con enmascaramiento);
    b. Cifra de neutrófilos <1,0 × 109/l (<1000 células/mm3);
    c. Cifra de trombocitos <50 × 109/l (<50 000 células/mm3);
    d. Aclaramiento de creatinina <30 ml/min (Cockroft-Gault).
    3. En la visita 14 del estudio principal (FDT), descenso >30 % del volumen espiratorio forzado en 1 segundo o la capacidad vital forzada basales del estudio principal.
    4. Acontecimientos adversos respiratorios clínicamente significativos y persistentes (AA; p. ej., disnea) que no se hayan resuelto antes de la administración de la primera dosis en el estudio de extensión.
    5. Edema macular en cualquier momento entre la visita 1 (selección) del estudio principal y el día 1 del estudio de extensión.
    6. Presencia de lo siguiente en la visita 14 del estudio principal (FDT, semana 108), visita de SG1 o visita abreviada de SG2, o el día 1 del estudio de extensión antes de la dosis:
    a. Presunta infección oportunista del sistema nervioso central o cualquier otra infección que, en opinión del investigador, contraindique el reinicio del fármaco del estudio;
    b. Síndrome de Stevens-Johnson, necrólisis epidérmica tóxica o reacción medicamentosa con eosinofilia y síntomas sistémicos.
    7. Necesidad e intención de administrar un tratamiento concomitante prohibido en el estudio
    8. Mujeres embarazadas o lactantes.
    9. Sujetos varones que deseen engendrar un hijo en cualquier momento anterior al período de 6 semanas tras la primera de dos pruebas consecutivas que confirmen un nivel de teriflunomida en plasma <0,02 mg/l.
    10. Uso de tratamientos modificadores de la enfermedad (TME) para la EM entre el FDT del estudio principal y la administración de la primera dosis en el estudio de extensión.
    11. Cualquier otra afección médica o quirúrgica de importancia clínica que, en opinión del investigador, pondría al sujeto en riesgo con la participación en el estudio.
    12. Sujetos que probablemente no cumplan el protocolo del estudio de extensión a criterio del investigador del protocolo del estudio principal, p. ej., poco cooperativos, incapacidad de volver para las visitas de seguimiento o que se sepa que es improbable que finalicen el estudio de extensión.
    E.5 End points
    E.5.1Primary end point(s)
    The main clinical and MRI-based endpoints are:
    - Annualized confirmed relapse rate (ARR; based on the number of confirmed relapses per subject-year);
    - Time from core study randomization to first confirmed relapse;
    - Time from core baseline to first 12-week confirmed disability accumulation (CDA);
    - Time from core baseline to first 24-week confirmed disability accumulation (CDA);
    - Percent change from baseline in brain volume (PCBV) at all assessments;
    - Cumulative number of combined unique active lesions (CUAL, defined as new Gd+ T1 lesions plus new or enlarging T2 lesions without double-counting the lesions) at all assessments.
    Los criterios de valoración principales clínicos y de resonancia magnética son:
    - Tasa de recidiva confirmada anualizada (TRA; basada en el número de recidivas confirmadas por año-sujeto).
    - Tiempo desde la aleatorización del estudio principal hasta la primera recidiva confirmada.
    - Tiempo desde el valor basal del estudio principal hasta la primera acumulación de discapacidad confirmada (ADC) a 12 semanas.
    - Tiempo desde el valor basal del estudio principal hasta la primera ADC a 24 semanas.
    - Cambio porcentual del volumen cerebral desde el valor basal en todas las evaluaciones.
    - Número acumulado de lesiones activas únicas combinadas (LAUC, definidas como la lesiones nuevas potenciadas en T1 con gadolinio más las lesiones nuevas o las lesiones existentes que han aumentado de tamaño en T2 sin contar dos veces las lesiones) en todas las evaluaciones.
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    N/A
    E.5.2Secondary end point(s)
    NA
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    N/A
    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 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) 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA83
    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
    Belarus
    Bosnia and Herzegovina
    Bulgaria
    Canada
    Croatia
    Czech Republic
    Finland
    France
    Georgia
    Germany
    Greece
    Hungary
    Israel
    Italy
    Latvia
    Lithuania
    Mexico
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Spain
    Sweden
    Turkey
    Ukraine
    United Kingdom
    United States
    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
    última visita del último paciente
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months5
    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: 800
    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 state71
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 800
    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)
    After the subject’s study completion or premature withdrawal from the study, whichever applies, the investigator/delegate will explain to subjects what treatment(s) / medical care is necessary and available according to local regulations.
    Después del fin de estudio o de la finalización prematura del estudio, según el caso, el investigador / delegado explicará a los pacientes qué tratamiento (s) / atención médica es necesaria y disponible según las regulaciones locales.
    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 Decision2017-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-04
    P. End of Trial
    P.End of Trial StatusOngoing
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