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    Summary
    EudraCT Number:2016-004046-28
    Sponsor's Protocol Code Number:AUR-VCS-2016-02
    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:2018-01-25
    Trial results View 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 number2016-004046-28
    A.3Full title of the trial
    A Randomized, Controlled, Double-blind, Continuation Study Comparing the Long-term Safety and Efficacy of Orelvo (voclosporin) (23.7 mg Twice Daily) with Placebo in Subjects with Lupus Nephritis
    Estudio de continuación, aleatorizado, controlado y en doble ciego, comparativo de la seguridad y la eficacia a largo plazo de Orelvo (voclosporina) (23,7 mg dos veces al día) frente a placebo en sujetos con nefritis lúpica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess the long-term safety and efficacy of Orelvo (voclosporin) compared with placebo in subjects with active lupus nephritis (LN)
    Estudio clínico para evaluar a largo plazo la seguridad y la eficacia de Orelvo (voclosporina) frente a placebo en sujetos con nefritis lúpica.
    A.3.2Name or abbreviated title of the trial where available
    AURORA (AURinia Orelvo Renal Assessments) 2: Aurinia Renal Response in Lupus with Orelvo
    Aurinia Respuesta Renal en Lupus active con Orelvo
    A.4.1Sponsor's protocol code numberAUR-VCS-2016-02
    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 SponsorAurinia Pharmaceuticals, Inc.
    B.1.3.4CountryCanada
    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 supportAurinia Pharmaceuticals, Inc.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWorldwide Clinical Trials Ltd
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Waterfront House, Beeston Business Park, Beeston
    B.5.3.2Town/ cityNottingham
    B.5.3.3Post codeNG9 1LA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0)207 1216161
    B.5.5Fax number+44(0)207 1216160
    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 nameOrelvo
    D.3.2Product code Voclosporin
    D.3.4Pharmaceutical form Capsule, soft
    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 INNVoclosporin
    D.3.9.1CAS number 515814-01-4
    D.3.9.2Current sponsor codeISA247
    D.3.9.3Other descriptive nameVOCLOSPORIN
    D.3.9.4EV Substance CodeSUB31127
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.9
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lupus Nephritis
    Nefritis Lúpica
    E.1.1.1Medical condition in easily understood language
    Lupus Nephritis
    Nefritis Lúpica
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10025140
    E.1.2Term Lupus nephritis
    E.1.2System Organ Class 10038359 - Renal and urinary 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 assess the long-term safety and tolerability of Orelvo compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus nephritis (LN).
    •Evaluar la seguridad y la tolerabilidad a largo plazo de Orelvo, frente a placebo, durante un máximo de 24 meses adicionales tras la finalización del tratamiento en el estudio AURORA 1 en sujetos con nefritis lúpica.
    E.2.2Secondary objectives of the trial
    To assess the long-term efficacy of Orelvo compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN
    Evaluar la eficacia a largo plazo de Orelvo, frente a placebo, durante un máximo de 24 meses adicionales tras la finalización del tratamiento en el estudio AURORA 1 en sujetos con nefritis lúpica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written informed consent before any study-specific procedures are performed.
    2.Male or female subjects who have completed 52 weeks of treatment with study drug in the AURORA 1 study. Subjects who had a temporary interruption and successfully restarted study drug during the AURORA 1 study will be allowed with Medical Monitor approval.
    3.In the opinion of the Investigator, subject requires continued immunosuppressive therapy.
    4.Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month 12. Two effective forms of contraception must be used simultaneously unless abstinence is the chosen method. Subjects must use effective contraception during the study (see Protocol Section 5.4, Adequate/Effective Contraception).
    5.Subject is willing to continue taking oral MMF for the duration of the study.
    1.Consentimiento informado por escrito antes de la práctica de cualquier procedimiento del estudio.
    2.Sujetos de ambos sexos que hayan concluido 52 semanas de tratamiento con el fármaco del estudio en el estudio AURORA 1. Con la aprobación del Monitor Médico, podrán participar los sujetos que hayan interrumpido temporalmente el fármaco del estudio y luego lo hayan reanudado de manera satisfactoria durante el estudio AURORA 1.
    3.En opinión del Investigador, el sujeto precisa tratamiento inmunosupresor continuo.
    4.Las mujeres potencialmente fértiles deberán continuar con la anticoncepción efectiva y dar negativo en una prueba de embarazo en orina realizada el Mes 12. Deberán utilizar simultáneamente dos métodos anticonceptivos efectivos, salvo si el método elegido fuera la abstinencia. Deberán mantener una anticoncepción efectiva durante el estudio (véase la Sección 5.4, Adequate/Effective Contraception).
    5.El sujeto está de acuerdo en continuar tomando MMF oral durante el estudio.
    E.4Principal exclusion criteria
    1.Subjects unable or unwilling to give written informed consent and/or to comply with study procedures.
    2.Currently taking or known need for any of the medications or food items listed in Protocol Section 7.8, Prohibited Therapy and Concomitant Treatment during the study.
    3.Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
    4.A planned kidney transplant within study treatment period.
    5.Subjects with any medical condition which, in the Investigator’s judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
    6.Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.
    7.Vaccines using live organisms, virus or bacterial, while taking the study treatment.
    1.Sujetos que no pueden o no desean otorgar su consentimiento informado por escrito y/o cumplir con los procedimientos del estudio.
    2.En tratamiento actual o con previsión de necesitar cualquiera de los medicamentos o alimentos enumerados en la Sección 7.8, Prohibited Therapy and Concomitant Treatment durante el estudio.
    3.Sometidos actualmente a diálisis renal (hemodiálisis o diálisis peritoneal) o previsión de precisarla durante el periodo del estudio.
    4.Trasplante renal programado durante el periodo de tratamiento del estudio.
    5.Todo proceso médico que, a juicio del Investigador, pueda suponer un mayor riesgo para el sujeto o interferir en las evaluaciones o resultados del estudio.
    6.Pacientes que estén embarazadas o lactando o que, si son potencialmente fértiles, no utilizan unas medidas anticonceptivas adecuadas.
    7.Vacunas con gérmenes vivos, ya sean víricas o bacterianas, durante el tratamiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events (AE) profile and routine biochemical and hematological assessments.
    Perfil de acontecimientos adversos y determinaciones analíticas habituales de bioquímica y hematología.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the study, but as part of that analysis, it will be looked at each study visit.
    Al final del estudio, pero como parte de ese análisis, se examinará en cada visita de studio.
    E.5.2Secondary end point(s)
    - Proportion of subjects in renal response defined as:
    · UPCR of ≤0.5 mg/mg
    · estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%
    · Received no rescue medication for LN
    · Did not receive more than 10 mg prednisone for ≥3 consecutive days or for ≥7 days in total during the 8 weeks prior to the renal response assessment.
    - Subjects who withdraw from the study prior to the response assessment will be defined as non-responders.
    - Proportion of subjects in partial renal response defined as a 50% reduction from baseline in UPCR.
    - Renal flare as adjudicated by the Clinical Endpoints Committee (CEC).
    - Extra-renal flare as adjudicated by the CEC.
    - SELENA-SLEDAI scores by visit.
    - Change in UPCR, eGFR, urine protein, and serum creatinine from AURORA 1 baseline.
    - Change in immunology parameters (complement 3 (C3), complement 4 (C4), and anti double-stranded deoxyribonucleic acid (DNA)) from AURORA 1 baseline.
    - Change in health-related quality of life (HRQoL) (SF-36) from AURORA 1 baseline.
    - Healthcare Resource Utilization (HRU).
    •Porcentaje de sujetos con respuesta renal, definida por:
    —Cociente proteínas/creatinina en orina ≤0,5 mg/mg
    —Tasa de filtración glomerular estimada ≥60 ml/min/1,73 m2 o ausencia de una disminución confirmada de la tasa de filtración glomerular estimada >20% frente al valor basal
    —No haber recibido medicación de rescate por la nefritis lúpica
    —No haber recibido más 10 mg de prednisona durante ≥3 días consecutivos o durante ≥7 días en total en las 8 semanas anteriores a la evaluación de la respuesta.
    •Los sujetos que se retiren del estudio antes de la evaluación de la respuesta se calificarán como no respondedores.
    •Porcentaje de sujetos con respuesta renal parcial, definida como una reducción del cociente proteínas/creatinina en orina del 50% frente al valor basal.
    •Brote renal clasificado por el Clinical Endpoints Committee (CEC).
    •Brote extrarrenal clasificado por el CEC.
    •Puntuación SELENA-SLEDAI por visita.
    •Cambio del cociente proteínas/creatinina en orina, la tasa de filtración glomerular estimada, las proteínas en orina y la creatinina sérica frente al valor basal del estudio AURORA 1.
    •Cambio de los parámetros inmunológicos (complemento 3 [C3], C4 y anti ácido desoxirribonucleico bicatenario) frente al valor basal del estudio AURORA 1.
    •Cambio de la calidad de vida relacionada con la salud (SF-36) frente al valor basal del estudio AURORA 1.
    •Utilización de recursos sanitarios.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Change in UPCR, eGFR, urine protein, and serum creatinine from AURORA 1 baseline at each visit.
    • Change in immunology parameters (C3, C4, and anti-dsDNA) from AURORA 1 baseline at each visit.
    • Change in HRQoL (SF-36) from AURORA 1 baseline at Months 12, 18, 24, 30, and 36.
    • Change in SELENA-SLEDAI scores by visit at Months 12, 18, 24, and 36.
    • Healthcare Resource Utilization at Months 12, 15, 18, 21, 24, 27, 30, 33, and 36. Key aspects will be summarized by visit and changes over time will be explored
    •Cambio del cociente proteínas/creatinina en orina, la tasa de filtración glomerular estimada, las proteínas en orina y la creatinina sérica frente al valor basal del estudio AURORA 1 en cada visita.
    •Cambio de los parámetros inmunológicos (C3, C4 y anti ácido desoxirribonucleico bicatenario) frente al valor basal del estudio AURORA 1 en cada visita.
    •Cambio de la calidad de vida relacionada con la salud (SF-36) frente al valor basal del estudio AURORA 1 en los Meses 12, 18, 24, 30 y 36.
    •Cambio de la puntuación SELENA-SLEDAI por visita en los Meses 12, 18, 24 y 36.
    •Utilización de recursos sanitarios en los Meses 12, 15, 18, 21, 24, 27, 30, 33 y 36. Se resumirán por visita los aspectos principales y se explorarán los cambios a lo largo del tiempo.
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Brazil
    Bulgaria
    Canada
    Chile
    Colombia
    Costa Rica
    Croatia
    Dominican Republic
    Guatemala
    Japan
    Korea, Republic of
    Macedonia, the former Yugoslav Republic of
    Malaysia
    Mexico
    Netherlands
    Peru
    Philippines
    Poland
    Puerto Rico
    Russian Federation
    Serbia
    South Africa
    Spain
    Sri Lanka
    Taiwan
    Thailand
    Turkey
    Ukraine
    United States
    Vietnam
    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
    ultima visita del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months15
    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: 310
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 324
    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 subjects who complete participation will return to standard of 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 Decision2018-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-17
    P. End of Trial
    P.End of Trial StatusOngoing
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