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    Summary
    EudraCT Number:2020-005807-37
    Sponsor's Protocol Code Number:AUR-VCS-2020-03
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2022-01-28
    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 ConcernedFrance - ANSM
    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
    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
    A.3.2Name or abbreviated title of the trial where available
    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 organisation Aurinia 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 number+1-250-708-4243
    B.5.5Fax number+1-250-508-3598
    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.3.4Pharmaceutical 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.3.9.4EV 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
    E.1.1.1Medical condition in easily understood language
    inflammation of the kidneys caused by autoimmune disease
    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.
    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.
    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
    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
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 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
    E.5.2.1Timepoint(s) of evaluation of this end point
    Refer to schedule of events
    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
    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 concerned4
    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 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
    Colombia
    France
    Israel
    Italy
    Korea, Republic of
    Mexico
    Netherlands
    Peru
    Spain
    Taiwan
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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.1.1Number of subjects for this age range: 40
    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 state4
    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.
    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 Decision2022-03-23
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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