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    EudraCT Number:2010-018329-20
    Sponsor's Protocol Code Number:LN-LAQ-201
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-18
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2010-018329-20
    A.3Full title of the trial
    A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Clinical Effect of Laquinimod in Active Lupus Nephritis Patients, in Combination with Standard of Care (Mycophenolate Mofetil and Steroids)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study is to find out whether a new oral drug, laquinimod, given in
    addition to the standard/routine treatment is safe and may improve
    lupus nephritis disease response to treatment.
    A.4.1Sponsor's protocol code numberLN-LAQ-201
    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 SponsorTeva Pharmaceutical Industries Ltd.
    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 supportTeva Pharmaceuticals ltd
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeav Pharma GmbH
    B.5.2Functional name of contact pointDr. Ekkehard Baader
    B.5.3 Address:
    B.5.3.1Street AddressWaldecker Str 7
    B.5.3.2Town/ cityMörfelden-Walldorf
    B.5.3.3Post code64546
    B.5.4Telephone number+496105 97676 17
    B.5.5Fax number+496105 97676 60
    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 nameLaquinimod Capsules 0.5 mg
    D.3.2Product code TV-5600
    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 INNlaquinimod
    D.3.9.1CAS number 248282-07-7
    D.3.9.2Current sponsor codeTV-5600
    D.3.9.3Other descriptive nameABR-215062 sodium salt
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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*
    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 is a kidney disorder that is a complication of systemic
    lupus erythematosus. Systemic lupus erythematosus (SLE, or lupus) is
    an autoimmune disease.
    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 13.1
    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 evaluate the safety and tolerability of two doses of laquinimod (0.5 mg and 1 mg/day), in subjects with active Lupus Nephritis in combination with standard of care (MMF and steroids).
    To evaluate biomarkers and clinical effect of two doses of laquinimod (0.5 mg and 1 mg/day), in subjects with active Lupus Nephritis in combination with standard of care (MMF and steroids).
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The following sub-study is described in the same Sponsor' protocol LN-LAQ-201:

    Voluntary participation in a pharmacogenetic sub-study:

    A single sample of approximately 6ml of blood will be collected only once during the study.

    The objective of this pharmacogenetic study is to collect and store DNA samples for use in future exploratory analyses for the assessment of possible associations between genetic polymorphisms and response to laquinimod.
    E.3Principal inclusion criteria
    1.Subjects diagnosed with SLE, who fulfilled at least 4 classification criteria of the American College of Rheumatology for SLE by the time of screening visit.
    2.Kidney biopsy within 12 months prior to baseline with a histological diagnosis of LN.
    3.Clinically active LN
    4.Subjects must be between the ages of 18 and 75 years (inclusive).
    5.Subjects are willing and able to provide a written informed consent.
    E.4Principal exclusion criteria
    1.GFR ≤ 30 ml/min/1.73m2 as calculated by MDRD formula at screening visit.
    2.Dialysis within the last month prior to screening or scheduled to receive dialysis.
    3.Previous kidney transplant or planned transplant.
    4.Subjects with hemoglobin < 8.5 g/dl or neutrophils < 1300/ mm3 or platelets < 50,000/mm3 at screening.
    5.Any previous diagnosis of drug induced lupus.
    6.Subjects with severe, unstable and/or progressive CNS lupus and/or associated with significant cognitive impairment.
    7.Subjects with a clinically significant or unstable medical or surgical condition that, in the Investigator’s opinion, would preclude safe and complete study participation, as determined by medical history, physical examinations, electrocardiogram (ECG), laboratory tests or imaging.
    8. MMF/steroids specific exclusion criteria:
    Pancreatitis within 6 months prior to screening.
    Gastrointestinal hemorrhage within 6 months prior to screening.
    Peptic ulcers (unhealed) within 3 months prior to screening
    Subject weight > 120kg (265 pound).
    9. Subjects with a ≥ 2.5x upper limit of normal (ULN) serum elevation of either ALT or AST at screening.
    10.Subjects with a ≥ 2x upper limit of normal direct or total bilirubin at screening.
    11.Subjects diagnosed with Diabetes Mellitus, or Anti-Neutrophil Cytoplasmic Antibodies (ANCA) Vasculitis.
    12.Medical condition, other than SLE that requires chronic treatment with immunosuppressive drugs or systemic corticosteroids (not including inhaled steroids).
    13.Subjects with a history of malignancy within 5 years from screening with the exception of basal cell carcinoma (completely excised).
    14.Women who are pregnant or nursing at the time of screening, or who intend to be during the study period.
    15.Women of child-bearing potential who do not practice an acceptable method of birth control.
    16.Subjects treated with MMF dose ≥ 2 g/day anytime between 31 days and 90 days prior to baseline or MMF dose >2 g/day within 30 days prior to baseline.
    17.Subjects treated with oral corticosteroids at doses higher than 20 mg/day of prednisolone/prednisone (or equivalent) anytime between 8 and 90 days prior to baseline or prednisolone/prednisone dose (or equivalent) >40 mg/day within 7 days prior to baseline or any IV or IM steroid dose within 90 days prior to baseline.
    18.Subjects treated with Azathioprine, MTX, Cyclosporine or Tacrolimus within 2 weeks prior to baseline.
    19.Subjects treated with cyclophosphamide within 12 weeks prior to screening.
    20.Subjects treated with Rituximab, abatacept, intravenous immune globulin (IV Ig), plasmapheresis or any other biologic therapy within 24 weeks prior to screening.
    21.Subjects treated with alkylating agents (other than cyclophosphamide such as: nitrogen mustard, chlorambucil, vincristine, procarbazine or etopside) within 52 weeks prior to screening.
    22.Subjects who received any investigational medication within 24 weeks prior to screening.
    23.Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (1 month for fluoxetine).
    24.Use of amiodarone within 2 years prior to screening visit.
    25.Subjects treated with sevelamer, acyclovir, valacyclovir, ganciclovir,
    rifampin, antacids that contain magnesium and aluminium hydroxide,
    norfloxacin, metronidazole or cholestyramine at screening or baseline.
    26.A known drug hypersensitivity that would preclude administration of study medications, such as known hypersensitivity to MMF, corticosteroids or hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate.
    27.Subjects unable to comply with the planned schedule of study visits and study procedures.
    E.5 End points
    E.5.1Primary end point(s)
    This study is exploratory in nature; therefore, no formal statistical hypothesis testing is planned.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All study outcome measures will be evaluated at week 24.
    E.5.2Secondary end point(s)
    E.5.2.1Timepoint(s) of evaluation of this end point
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Clinical effect
    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. 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 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 EEA7
    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
    Russian Federation
    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 study will be completed upon completion of the 4 weeks follow up period following 24 weeks of treatment.
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 45
    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)
    Mycophenolate mofetil or other immunosuppressive administration may be continued per the investigator discretion, under prescription.
    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 Decision2010-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-24
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