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    Summary
    EudraCT Number:2020-005807-37
    Sponsor's Protocol Code Number:AUR-VCS-2020-03
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-08-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-005807-37
    A.3Full title of the trial
    A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescents with Lupus Nephritis
    Studio in doppio cieco, controllato con placebo, con incremento della dose volto a valutare l'efficacia, la sicurezza e la farmacocinetica della voclosporina in adolescenti affetti da nefrite lupoide
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at the effect and how safe the drug, Voclosporin, is in adolescents with a type of kidney disease called Lupus Nephritis
    Studio che guarda l'effetto e quanto il farmaco sia sicuro, Voclosporina, in adolescenti con un tipo di malattia renale chiamata Nefrite Lupoide
    A.3.2Name or abbreviated title of the trial where available
    VOCAL
    VOCAL
    A.4.1Sponsor's protocol code numberAUR-VCS-2020-03
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/152/2019
    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 organisationAurinia Pharmaceuticals Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address1203-4464 Markham Street
    B.5.3.2Town/ cityVictoria
    B.5.3.3Post codeV8Z 7X8
    B.5.3.4CountryCanada
    B.5.4Telephone number0012507084243
    B.5.5Fax number0012505083598
    B.5.6E-mailclinicaltrials@auriniapharma.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 nameVoclosporin
    D.3.2Product code [-]
    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 code-
    D.3.9.4EV Substance CodeSUB31127
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7900
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Nefrite Lupoide
    E.1.1.1Medical condition in easily understood language
    Inflammation of the kidneys caused by autoimmune disease.
    Infiammazione dei reni causata da malattia autoimmune
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescents with active LN.
    Valutare l'efficacia della voclosporina rispetto al placebo nel raggiungimento della risposta renale dopo 24 settimane di terapia in adolescenti affetti da LN attiva.
    E.2.2Secondary objectives of the trial
    •To assess the safety and tolerability of voclosporin over 24 weeks in adolescents with active LN.
    •To assess the pharmacokinetics (PK) and pharmacodynamics (PD) of voclosporin in adolescents with LN.
    •To assess the palatability and acceptability of voclosporin softgel capsules.
    • Valutare la sicurezza e la tollerabilità della voclosporina nell'arco di 24 settimane in adolescenti affetti da LN attiva.
    • Valutare la farmacocinetica (Pharmacokinetics, PK) e la farmacodinamica (Pharmacodynamics, PD) della voclosporina in adolescenti affetti da LN.
    • Valutare l'appetibilità e l'accettabilità delle capsule di gelatina molle di voclosporina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects 12 to <18 years of age at the time of screening
    2. Previous diagnosis of SLE according to the 2019 EULAR/ACR classification criteria.
    3. Subjects with kidney biopsy result, with evidence of active nephritis

    Refer to protocol for full list of inclusion criteria.
    1. Soggetti di sesso maschile o femminile di età compresa tra 12 e <18 anni al momento dello screening
    2. Precedente diagnosi di lupus eritematoso sistemico (LES) secondo i criteri di classificazione del 2019 della EULAR/ACR.
    3. Soggetti che secondo il risultato di una biopsia renale, presentano evidenza di nefrite attiva.

    Si prega di far riferimento al protocollo per la lista completa dei criteri di inclusione.
    E.4Principal exclusion criteria
    1. Estimated glomerular filtration rate of <60 mL/min/1.73 m2 at screening confirmed before randomization
    2. Use of immunosuppression biologic agents within 12 weeks prior to randomization
    3. Use of cyclophosphamide, cholestyramine, calcineurin inhibitors, live attenuated vaccines and initiation or dose changes in ARBs and ACEi within 4 weeks prior to
    randomisation
    4. Use of Strong CYP3A4/5 inhibitors and inducers within 2 weeks prior to randomization
    5. Currently requiring renal dialysis or expected to require dialysis during the study period
    6. A previous kidney transplant or planned transplant within study treatment period.
    7. 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.
    8. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions
    Refer to protocol for full list of exclusion criteria
    1. Velocità di filtrazione glomerulare stimata <60 ml/min/1,73 m2 allo screening confermata prima della randomizzazione
    2. Uso di agenti biologici immunosoppressori entro 12 settimane prima della randomizzazione
    3. Uso della ciclofosfamide, colestiramina, inibitori della calcineurina, vaccini vivi attenuati e avvio o modifica del dosaggio degli ARBs e ACEi entro le 4 settimane prima
    della randomizzazione
    4. Uso di forti inibitori e induttori del CYP3A4/5 entro le 2 settimane prima della randomizzazione
    5. Necessità di dialisi renale attuale o prevista durante il periodo dello studio
    6. Precedente trapianto di rene o trapianto pianificato durante il periodo di trattamento dello studio
    7. Qualsiasi altra condizione medica che, a giudizio dello sperimentatore, potrebbe essere associata a un aumento del rischio per il soggetto o interferire con le valutazioni o gli esiti dello studio.
    8. Soggetti in gravidanza, che allattano al seno o, se potenzialmente fertili, che non utilizzano adeguate precauzioni contraccettive.
    Si prega di far riferimento al protocollo per la lista completa dei criteri di esclusione.
    E.5 End points
    E.5.1Primary end point(s)
    Renal response at Week 24 will be adjudicated by the Clinical Endpoints Committee (CEC) based on the following parameters:
    • UPCR of <=0.5 mg/mg, and
    • eGFR >=60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%, and
    • Received no rescue medication for LN, and
    • Did not receive >10 mg/day prednisone for >=3 consecutive days or for >=7 days in total between Week 16 and Week 24.
    La risposta renale alla Settimana 24 sarà giudicata dal Comitato per gli endpoint clinici (CEC) in base ai seguenti parametri:
    • UPCR <= 0,5 mg/mg, e
    • eGFR >= 60 ml/min/1,73 m2 o nessuna riduzione confermata rispetto al basale dell'eGFR > 20%, e
    • Nessun utilizzo del farmaco di soccorso per la LN, e
    • Nessun utilizzo di >10 mg/die di prednisone per >=3 giorni consecutivi o per >=7 giorni in totale tra la Settimana 16 e la Settimana 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 24
    Alla settimana 24
    E.5.2Secondary end point(s)
    • Time to UPCR of <=0.5 mg/mg.
    • UPCR of <=0.7 mg/mg at Week 24.
    • Time to UPCR of <=0.7 mg/mg.
    • Partial renal response as defined by >=50% reduction from baseline in UPCR at Week 24.
    • Time to 50% reduction in UPCR from baseline.
    • Proportion of subjects with renal flare, defined as:
    o At least a doubling in UPCR to >=1.0 mg/mg for Class III, IV-S, or Class IVG alone or in combination with Class V or >=2.0 mg/mg for Class V only
    OR
    o At least a doubling in serum creatinine to >=120 µmol/L (~1.37 mg/dL).
    • Proportion of subjects with extra-renal flare, defined as an increase in 4-6 points on the extra-renal domains in the Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score at Week 24.
    • Change from baseline in UPCR at each time point up to and including Week 24.
    • Change from baseline in eGFR, urine protein and serum creatinine at each time point up to and including Week 24.
    • Proportion of subjects with a decrease in eGFR >30% at each time point up to and including Week 24.
    • Change from screening in immunology parameters (complement 3 (C3), C4, and anti-double-stranded DNA) at each time point up to and including Week 24.
    • Change from baseline in the SELENA-SLEDAI score at Week 24.
    • Proportion of subjects with prednisone equivalent <7.5 mg/day at Week 24.
    • Adverse events (AE) profile, electrocardiograms (ECGs) and routine biochemical and hematological assessment over time up to and including Week 24 plus Safety Follow-Up period.
    • PK parameters and calcineurin inhibition of voclosporin at steady state (Week 8)
    • Palatability and acceptability of voclosporin softgel capsules
    Tempo all'UPCR <=0,5 mg/mg.
    • UPCR <=0,7 mg/mg alla Settimana 24.
    • Tempo all'UPCR <=0,7 mg/mg.
    • Risposta renale parziale definita da una riduzione >=50% rispetto al basale dell'UPCR alla Settimana 24.
    • Tempo alla riduzione del 50% dell'UPCR rispetto al basale.
    • Percentuale di soggetti con riacutizzazione renale, definita come:
    o Almeno un raddoppio dell'UPCR a >=1,0 mg/mg per la Classe III, IV-S o Classe IVG da sola o in combinazione con la Classe V o >=2,0 mg/mg per la Classe V da sola
    OPPURE
    o Almeno un raddoppio della creatinina sierica a >=120 µmol/l (~1,37 mg/dl).
    • Percentuale di soggetti con riacutizzazione extra-renale, definita come un aumento di 4-6 punti nei domini extra-renali del punteggio Sicurezza degli estrogeni nel lupus eritematoso, valutazione nazionale dell'indice di attività della malattia del lupus eritematoso sistemico (Safety of Estrogens in Lupus Erythematosus National Assessment - Systemic Lupus Erythematosus Disease Activity Index, SELENA-SLEDAI) alla Settimana 24.
    • Variazione rispetto al basale dell'UPCR a ogni punto temporale fino alla Settimana 24 inclusa.
    • Variazione rispetto al basale di eGFR, proteine urinarie e creatinina sierica a ogni punto temporale fino alla Settimana 24 inclusa.
    • Percentuale di soggetti con una riduzione dell'eGFR >30% a ogni punto temporale fino alla Settimana 24 inclusa.
    • Variazione rispetto allo screening dei parametri immunologici (componente 3 del complemento [C3], C4 e anticorpi anti-DNA a doppia elica) a ogni punto temporale fino alla Settimana 24 inclusa.
    • Variazione rispetto al basale del punteggio SELENA-SLEDAI alla Settimana 24.
    • Percentuale di soggetti trattati con una dose di prednisone equivalente <7,5 mg/die alla Settimana 24.
    • Profilo degli eventi avversi (Adverse Event, AE), elettrocardiogrammi (ECG) e valutazione biochimica ed ematologica di routine nel corso del tempo fino alla
    Settimana 24 inclusa, più il periodo di follow-up di sicurezza.
    • Parametri di PK e inibizione della calcineurina ad opera della voclosporina allo stato stazionario (Settimana 8).
    • Palatabilità e accettabilità delle capsule molli di voclosporina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Refer to schedule of events
    Si prega di far riferimento al calendario degli eventi.
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability and palatability and acceptability of voclosporin softgel capsules
    Tollerabilità e patabilità e accettabilità delle capsule di gelatina molle di voclosporina
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Colombia
    Peru
    Taiwan
    France
    Israel
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    Spain
    Thailand
    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
    The End of Study is defined as the date of the last subject’s last visit, which is the End of Study Visit (Visit 13) for subjects that enroll into the VOCAL-EXT study, and the Safety Follow-Up Visit (Visit 14) for subjects that do not continue into the VOCAL-EXT study
    The End of Study is defined as the date of the last subject’s last visit, which is the End of Study Visit (Visit 13) for subjects that enroll into the VOCAL-EXT study, and the Safety Follow-Up Visit (Visit 14) for subjects that do not continue into the VOCAL-EXT study
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 40
    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 that complete participation and study treatment through 24 weeks will have the opportunity to enroll into an open-label extension study to receive further
    treatment with voclosporin.
    Tutti i soggetti che completano la partecipazione e il trattamento in studio per 24 settimane avranno l'opportunità di partecipare ad uno studio di estensione in aperto per
    ricevere un ulteriore trattamento con voclosporin.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-04
    P. End of Trial
    P.End of Trial StatusOngoing
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