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    Summary
    EudraCT Number:2015-002500-91
    Sponsor's Protocol Code Number:RPC01-3001
    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:2015-10-05
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-002500-91
    A.3Full title of the trial
    A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
    Estudio multicéntrico de extensión abierta de RPC1063 oral en la esclerosis múltiple recidivante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis
    Estudio abierto multicéntrico de extensión de RPC1063 oral en la esclerosis múltiple de repetición.
    A.3.2Name or abbreviated title of the trial where available
    Open Label Extension (OLE) study
    Estudio de Extensión abierto
    A.4.1Sponsor's protocol code numberRPC01-3001
    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 SponsorReceptos, Inc.
    B.1.3.4CountryUnited States
    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 supportReceptos, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressFleming House,Phoenix Crescent, Strathclyde Business Park
    B.5.3.2Town/ cityBellshill, Lanarkshire
    B.5.3.3Post codeML4 3NJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34900 834223
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 name0.25mg RPC1063
    D.3.2Product code RPC1063
    D.3.4Pharmaceutical form Capsule, hard
    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 INNOzanimod
    D.3.9.2Current sponsor codeRPC1063
    D.3.9.4EV Substance CodeSUB175614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 name1.0mg RPC1063
    D.3.2Product code RPC1063
    D.3.4Pharmaceutical form Capsule, hard
    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 INNOzanimod
    D.3.9.2Current sponsor codeRPC1063
    D.3.9.4EV Substance CodeSUB175614
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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
    Relapsing Multiple Sclerosis
    Esclerosis múltiple de repetición
    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 18.0
    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
    To characterize the long-term safety and tolerability of RPC1063 in patients with relapsing multiple sclerosis.
    Caracterizar la seguridad y la tolerabilidad a largo plazo de RPC1063 en pacientes con esclerosis múltiple recidivante.
    E.2.2Secondary objectives of the trial
    To characterize the long-term efficacy of RPC1063 in patients with relapsing multiple sclerosis.
    Caracterizar la eficacia a largo plazo de RPC1063 en pacientes con esclerosis múltiple recidivante
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in this trial, patients must meet all of the following criteria:
    1. Completed one of the parent trials: RPC01-201 or RPC01-301
    2. Does not have a condition that would require withdrawal from one of the parent trials (RPC01-201 or RPC01-301)
    3. Has no conditions requiring treatment with a prohibited concomitant medication
    4. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
    5. Patients of reproduction potential (males and females) must practice an acceptable method of birth control (acceptable methods of birth control in this trial include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long acting injectable contraceptive, vasectomy or double-barrier method [condom or diaphragm with spermicide OR condom and diaphragm]) during trial participation and for 30 days after their last dose of treatment of investigational drug or true sexual abstinence (periodic abstinence [calendar, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). Patients must follow the strictest applicable local requirement as specified by the Regulatory Agency or Ethics Committee approving the trial.
    Para poder participar en este ensayo, los pacientes deben cumplir todos los siguientes criterios:
    1. Finalización de uno de los ensayos originales: RPC01-201 o RPC01-301
    2. No padece ninguna enfermedad que requiera su retirada de uno de los ensayos originales (RPC01-201 o RPC01-301)
    3. No padece ninguna enfermedad que requiera tratamiento con un medicamento concomitante prohibido
    4. Capacidad para otorgar su consentimiento informado por escrito y cumplir el calendario de evaluaciones del protocolo
    5. Los pacientes con capacidad de procrear (varones y mujeres) deberán utilizar un método anticonceptivo aceptable (los métodos anticonceptivos aceptables en este ensayo son:
    esterilización quirúrgica, dispositivos intrauterinos, anticonceptivo oral, parche anticonceptivo, anticonceptivo inyectable de acción prolongada, vasectomía o método de doble barrera [preservativo o diafragma con espermicida o preservativo y diafragma]) durante
    la participación en el estudio y durante 30 días después de su última dosis de medicación del estudio o verdadera abstinencia sexual (la abstinencia periódica [métodos del calendario, sintotérmico y postovulación] y la retirada no son métodos anticonceptivos aceptables). Los pacientes deben cumplir los requisitos locales aplicables más estrictos especificados por las autoridades sanitarias o el comité ético que autorice el ensayo.
    E.4Principal exclusion criteria
    Patients that have a condition that would require withdrawal from one of the parent trials (RPC01-201 or RPC01-301)
    Pacientes que tuvieran condiciones que les hiciera discontinuar de uno de los dos ensayos padres (RPC01-201 or RPC01-301).
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints
    Safety and tolerability will be characterized in this trial by the incidence, relationship, and type of adverse events, serious adverse events, and adverse events leading to withdrawal from the trial; the incidence, relationship, and type of laboratory abnormalities; vital signs; electrocardiogram results; and physical examination abnormalities. Suicidality (Columbia-Suicide Severity Rating Scale) will be assessed in the trial. In addition, descriptive characterization will be provided for adverse events of special interest including bradycardia and heart conduction abnormalities (electrocardiogram and vital signs), pulmonary effects (forced expiratory volume at 1 second, forced vital capacity, and diffusing capacity of the lung for carbon monoxide measurements), macular edema (optical coherence tomography), hepatic effects (liver function tests), serious or opportunistic infections, and malignancy.

    Efficacy Endpoints
    - Annualized relapse rate
    - Time to first relapse
    - The number of new or enlarging hyperintense T2-weighted brain magnetic resonance imaging lesions at each visit
    - The number of gadolinium-enhanced brain magnetic resonance imaging lesions at each visit
    -Time to onset of disability progression as defined by a sustained worsening in Expanded Disability Status Scale of 1.0 points or more, confirmed after 3 months and after 6 months
    -Proportion of patients who are free of gadolinium-enhanced lesions at each visit
    - Proportion of patients who are free of new or enlarging T2 lesions at each visit
    - Percent change in normalized brain volume (atrophy) on brain magnetic resonance imaging scans from Baseline at each visit
    -Change in Multiple Sclerosis Functional Composite score from Baseline at each visit (including the Low-Contrast Letter Acuity Test measurement of visual function as a component)
    -Change in Multiple Sclerosis Quality of Life 54 score from Baseline at each visit
    -Changes in other magnetic resonance imaging variables including number and volume of gadolinium-enhanced T1 lesions, volume of T2 lesions, number of new or enlarging T2 lesions, volume of unenhancing T1 lesions, number of new unenhancing T1 lesions
    Criterios de valoración de la seguridad:
    La seguridad y la tolerabilidad se caracterizarán en este ensayo mediante la incidencia, la relación causal y el tipo de acontecimiento adverso, los acontecimientos adversos graves y los acontecimientos
    adversos que ocasiones la retirada del ensayo; la incidencia, la relación causal y el tipo de anomalía analítica; constantes vitales; resultados de los electrocardiogramas y las anomalías detectadas en la
    exploración física. En el ensayo se evaluarán las tendencias suicidas (escala de valoración de la gravedad del riesgo suicida). Además, se facilitará la caracterización descriptiva de los acontecimientos adversos de especial interés, como bradicardia y anomalías de la conducción cardíaca (electrocardiograma y constantes vitales), efectos pulmonares (mediciones del volumen espiratorio máximo en el primer segundo, de la capacidad vital forzada y de la capacidad de difusión
    pulmonar del monóxido de carbono), edema macular (tomografía de coherencia óptica), efectos hepáticos (pruebas de función hepática), infecciones graves u oportunistas, y neoplasias malignas.
    Criterios de valoración de la eficacia:
    -Tasa anualizada de recidivas
    - Tiempo hasta la primera recidiva
    - Número de lesiones hiperintensas nuevas o con aumento de tamaño en resonancia magnética cerebral ponderadas en T2 en cada visita
    - Número de lesiones en resonancia magnética cerebral realzada con gadolinio en cada visita
    -Tiempo hasta la aparición de progresión de la discapacidad, definida como un empeoramiento mantenido de la puntuación de la escala ampliada del estado de discapacidad de 1,0 puntos o
    más, confirmado después de 3 meses y después de 6 meses
    - Proporción de pacientes sin lesiones realzadas con gadolinio en cada visita
    - Proporción de pacientes sin lesiones ponderadas en T2 nuevas o con aumento de tamaño en cada visita
    - Variación porcentual del volumen cerebral normalizado (atrofia) en resonancia magnética cerebral en cada visita con respecto al momento basal
    - Variación de la puntuación de la escala funcional compuesta para la esclerosis múltiple en cada visita con respecto al momento basal (incluida la determinación de la función visual mediante la prueba de la agudeza con letras de bajo contraste como componente)
    -Variación de la puntuación de la escala de calidad de vida en la esclerosis múltiple-54 en cada visita con respecto al momento basal
    ? Variaciones en otras variables de resonancia magnética como el número y el volumen de lesiones realzadas con gadolinio ponderadas en T1, volumen de las lesiones ponderadas en T2, número de lesiones ponderadas en T2 nuevas o con aumento de tamaño, volumen de las
    lesiones no ponderadas en T1, número de lesiones nuevas no ponderadas en T1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 3 month visit, follow-up visit and during the unscheduled relapse visit if applicable
    Visita cada 3 meses , visita de seguimiento y durante la visita no programada de recaida si aplicara.
    E.5.2Secondary end point(s)
    None
    Ninguno
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    NA
    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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA190
    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
    Belarus
    Belgium
    Bosnia and Herzegovina
    Bulgaria
    Canada
    Colombia
    Croatia
    Estonia
    Georgia
    Germany
    Greece
    Hungary
    Italy
    Latvia
    Lithuania
    Mexico
    Moldova, Republic of
    Netherlands
    New Zealand
    Peru
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Sweden
    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
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 2350
    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 state76
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2143
    F.4.2.2In the whole clinical trial 2350
    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)
    All patients who are receiving clinical benefit from treatment with RPC1063 to continue to receive it until marketing authorization is obtained in their country, or until the Sponsor discontinues the development program.
    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 Decision2015-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-10
    P. End of Trial
    P.End of Trial StatusOngoing
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