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    Summary
    EudraCT Number:2012-003364-51
    Sponsor's Protocol Code Number:AUR-VCS-2012-01
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-12
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2012-003364-51
    A.3Full title of the trial
    A Randomized, Controlled Double-blind Study Comparing the Efficacy and Safety of Voclosporin (23.7 mg BID, or 39.5 mg BID) with Placebo in Achieving Remission in Patients with Active Lupus Nephritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study comparing the efficacy in the achievement of the remission (measured as reduction of proteinuria) and safety of two different doses of voclosporin and non active drug (placebo) in patients suffering from active lupus nephritis
    A.4.1Sponsor's protocol code numberAUR-VCS-2012-01
    A.5.4Other Identifiers
    Name:INDNumber:114577
    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 organisationAurinia Pharmaceuticals Inc.
    B.5.2Functional name of contact pointRobert Huizinga
    B.5.3 Address:
    B.5.3.1Street Address#1203 - 4464 Markham Street
    B.5.3.2Town/ cityVictoria, BC
    B.5.3.3Post codeV8Z 7X8
    B.5.3.4CountryCanada
    B.5.4Telephone number+1 (250) 744-2488
    B.5.5Fax number+1 (250) 744-2498
    B.5.6E-mailrhuizinga@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 ISA247
    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
    Active lupus nephritis
    E.1.1.1Medical condition in easily understood language
    Lupus nephritis manifests as diverse patterns of immune complex-mediated renal disease affecting glomerular, tubulointerstitial, and vascular compartments.
    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 17.1
    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 2 doses of voclosporin compared to placebo in achieving complete remission after 24 weeks of therapy in subjects with active Lupus Nephritis (LN).
    E.2.2Secondary objectives of the trial
    • To assess the safety and tolerability of 2 doses of voclosporin over 48 weeks
    compared to placebo in subjects with active LN.

    • To assess the efficacy of 2 doses of voclosporin versus placebo over 48 weeks in
    subjects with active LN.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent (by subject or legally acceptable representative) before any study-specific procedures are performed.
    2. Male or female subjects aged 18 to 75 years inclusive at the time of consent.
    3. Diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria (1997; see Appendix 7).
    4. Kidney biopsy within 6 months prior to screening (Visit 1) with a
    histologic diagnosis of lupus nephritis (International Society of
    Nephrology/Renal Pathology Society 2003 classification of lupus
    nephritis) Classes III, IV-S or IV-G, (A) or (A/C); or Class V, alone or in
    combination with Class III or IV; see Appendix 5. If a subject has not
    had a recent kidney biopsy, one may be performed to assess eligibility
    into the study provided consent is in place and provided results are
    received before randomization.
    5. Subjects with laboratory evidence of active nephritis at screening,
    defined as
    follows:
    • Class III, IV-S or IV-G
    Confirmed proteinuria ≥1,500 mg/24 hours when assessed by 24-hour
    urine collection, defined by a urine protein/creatinine ratio (UPCR) of ≥
    1.5 mg/mg assessed in a first morning void urine specimen (2 samples).
    • Class V (alone or in combination with Class III or IV)
    Confirmed proteinuria ≥2,000 mg/24 hours when assessed by 24-hour
    urine collection, defined by a UPCR of ≥2 mg/mg assessed in a first
    morning void urine specimen (2 samples).


    6. In the opinion of the Investigator, subject requires high dose corticosteroids and immunosuppressive therapy.
    E.4Principal exclusion criteria
    1. Subjects unable or unwilling to give written informed consent and/or to comply with study procedures.
    2. Estimated glomerular filtration rate (eGFR) as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation of ≤45 mL/min/1.73 m2 at screening (Visit 1)
    3. Currently taking or known need for any of the medications listed in Section 7.8, Prohibited Therapy and Concomitant Treatment, page 58.
    4. Serum potassium >5.5 mmol/L at screening confirmed before randomization.
    5. Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
    6. A previous kidney transplant or planned transplant within study treatment period.
    7. In the opinion of the Investigator, subject does not require long-term immunosuppressive treatment (in addition to corticosteroids).
    8. Any known hypersensitivity or contraindication to MMF, mycophenolic acid, cyclosporine, corticosteroids or any components of these drug products.
    9. Current or medical history of:
    • Pancreatitis or gastrointestinal hemorrhage within 6 months prior to screening.
    • Active unhealed peptic ulcer within 3 months prior to screening. If an ulcer has healed and the subject is on adequate therapy, the subject may be randomized.
    • Congenital or acquired immunodeficiency.
    • In the opinion of the Investigator, clinically significant drug or alcohol abuse 2 years prior to screening.
    • Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia 1, but have been treated with conization or loop electrosurgical excision procedure, and have had a normal repeat PAP are allowed.
    • Lymphoproliferative disease or previous total lymphoid irradiation.
    • Severe viral infection (such as CMV, HBV, HCV) within 3 months of screening; or known human immunodeficiency virus infection.
    • Active tuberculosis (TB), or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
    10. Other known clinically significant active medical conditions, such as:
    • Severe cardiovascular disease including congestive heart failure, history of cardiac dysrhythmia or congenital long QT syndrome. QTcF (QT interval duration corrected for heart rate using method of Fridericia) exceeding 480 msec in the presence of a normal QRS interval (<110 msec) at time of screening will result in exclusion.
    • Liver dysfunction (aspartate aminotransferase, alanine aminotransferase, or bilirubin greater than 2.5 times the upper limit of normal) at screening and confirmed before randomization.
    • Chronic obstructive pulmonary disease or asthma requiring oral steroids.
    • Bone marrow insufficiency unrelated to active SLE (according to Investigator judgment) with white blood cell count <2,500/mm3; absolute neutrophil count <1.3 × 103/μL; thrombocytopenia (platelet count <50,000/mm3).
    • Active bleeding disorders.
    • Current infection requiring IV antibiotics.
    11. Any overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes (e.g., scleroderma with significant pulmonary hypertension; any condition for
    which additional immunosuppression is indicated). Overlapping conditions for which the condition or treatment is not expected to affect assessments or outcomes (e.g., Sjogren’s syndrome) are not excluded.
    12. Other major physical or psychiatric illness or major traumatic injury within 6 months prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    The number of subjects achieving complete remission at 24 weeks. Complete remission is defined as:
    • Confirmed protein/creatinine ratio of ≤0.5 mg/mg and
    • eGFR ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in
    eGFR of ≥20%.
    Subjects who receive rescue medication for lupus (see Section 7.8,
    Prohibited Therapy and Concomitant Treatment) or >10 mg prednisone
    for >3 consecutive days or >7 days total from Weeks 16-26 will not be
    considered as achieving complete remission.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    • Complete remission as per the primary endpoint analyzed at Week 48.
    • Complete remission in the presence of low dose steroids at Week 24 (defined as confirmed complete remission and ≤5 mg prednisone for ≥8 weeks) and Week 48 (defined as confirmed complete remission and ≤5 mg prednisone for ≥12 weeks).
    • Time to complete remission.
    • Time to (and proportion achieving) early, sustained complete remission (defined as complete remission which occurs on or before Week 24 which is sustained through Week 48).
    • Time to sustained complete remission (defined as the first occurrence of complete remission which is sustained through Week 48).
    • Duration of complete remission (in months).
    • Partial remission as defined by 50% reduction in protein/creatinine ratio from
    baseline at Weeks 24 and 48.
    • Time to partial remission.
    • Time to (and proportion achieving) early, sustained partial remission (partial
    remission which occurs on or before Week 24 which is sustained through
    Week 48).
    • Time to sustained partial remission (defined as the first occurrence of partial
    remission which is sustained through Week 48).
    • Change from baseline in UPCR at Weeks 24 and 48.
    • Change from baseline in the Safety of Exogenous Estrogens in Lupus
    Erythematosus National Assessment - Systemic Lupus Erythematosus Disease
    Activity Index score at Weeks 24 and 48.
    • Change from baseline in serum creatinine, urine protein, serum albumin, eGFR
    at each visit measured.
    • Proportion of subjects with active urinary sediment (defined by >10 red blood
    cells (RBC) per high powered field with dysmorphic RBC and/or RBC casts on
    urinalysis of a urine sample which has a minimum volume of 50 mL) at each
    visit measured.
    • Change from screening in immunology parameters (C3, C4, and antidsDNA)
    and biomarkers (to be determined) at Weeks 12, 24 ,and 48
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints as specified in section E.5.1.1
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Bulgaria
    Georgia
    Guatemala
    Mexico
    Poland
    Russian Federation
    Serbia
    Spain
    Sri Lanka
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee No
    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 years1
    E.8.9.1In the Member State concerned months8
    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 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: 228
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 258
    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)
    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 Decision2014-10-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-06
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