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    Summary
    EudraCT Number:2017-003101-17
    Sponsor's Protocol Code Number:1293-0013
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-05
    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 ConcernedFrance - ANSM
    A.2EudraCT number2017-003101-17
    A.3Full title of the trial
    An exploratory maintenance trial evaluating the effect of BI 655064 in Lupus Nephritis patients who have achieved a meaningful response either at the end of 1293.10 or after an induction treatment outside of 1293.10
    Etude exploratoire de maintenance évaluant l’effet du BI 655064 chez des patients atteints de néphropathie lupique et ayant présenté une réponse significative soit à la fin de l’étude 1293.10 soit après un traitement d’induction en dehors de l’étude 1293.10
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An exploratory maintenance trial of BI 655064 in patients with lupus nephritis
    A.4.1Sponsor's protocol code number1293-0013
    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 SponsorBoehringer Ingelheim France
    B.1.3.4CountryFrance
    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 supportBoehringer Ingelheim France
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim GmbH & Co KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55126
    B.5.3.4CountryGermany
    B.5.4Telephone number+1800243027
    B.5.5Fax number+18008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 nameBI 655064
    D.3.2Product code BI 655064 120 mg (180 mg/ml)
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeBI 655064
    D.3.9.3Other descriptive nameBI 655064
    D.3.9.4EV Substance CodeSUB180326
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typehumanized non-depleting antagonistic therapeutic antibody
    D.IMP: 2
    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 nameBI 655064
    D.3.2Product code BI 655064 180 mg (180 mg/ml)
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.2Current sponsor codeBI 655064
    D.3.9.3Other descriptive nameBI 655064
    D.3.9.4EV Substance CodeSUB180326
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typehumanized non-depleting antagonistic therapeutic antibody
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous 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
    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
    The main objectives of this trial are to evaluate the long term efficacy and safety of different
    doses of BI 655064 versus placebo as add-on therapy to SOC during maintenance therapy for
    lupus nephritis.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patients.
    - Women of childbearing potential* and men able to father a child must be ready and able
    to use two reliable methods of birth control simultaneously, one of which must be highly
    effective. Highly effective birth control per ICH M3(R2) is a method that result in a low
    failure rate of less than 1% per year when used consistently and correctly. The reliable
    methods of birth control must be used before starting MMF/AZA and the trial drug; then continue during the trial period; and for at least 50 days after the last dose of MMF and trial medication. In case a female patient is treated with AZA the contraception shall continue for 90 days after treatment with AZA. A list of contraception methods meeting these criteria is provided in
    the patient information.
    - Sexually active men must be ready to use condoms ** during treatment with MMF and
    for at least 90 days after cessation of MMF.
    * A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming
    postmenopausal unless permanently sterile.
    - Permanent sterilisation methods include hysterectomy, bilateral oophorectomy and bilateral
    salpingectomy.
    - Tubal ligation is NOT a method of permanent sterilisation.
    - A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
    ** Condoms are applied for both reproductively competent and vasectomised men, because the risks
    associated with the transfer of seminal fluid also apply to men who have had a vasectomy. In addition,
    female partners of male patients treated with MMF are recommended to use highly effective
    contraception during treatment and for a total of 90 days after the last dose of MMF.
    - Signed and dated written informed consent in accordance with ICH-GCP and local
    legislation prior to admission to the trial.
    For Group 1 patients only:
    - Achieved either a CRR or a PRR or proteinuria ≤ 1g/d (or UP/UC ≤ 1) at the end of
    1293.10.
    For Group 2 patients only:
    - Age 18 –70 years at screening. For patients in Japan, age 20 – 70 years at screening.
    - Diagnosis of SLE by American College of Rheumatology (ACR) criteria 1997 with at
    least 4 criteria documented, one of which must either be a positive ANA or a positive
    anti-dsDNA antibody at the time of starting induction therapy (historical data).
    - Lupus Nephritis Class III or IV (co-existing class V permitted) based on ISN/RPS 2003
    classification with either active or active/chronic disease, proven by renal biopsy before
    the start of induction therapy (historical data).
    - Achieved either a CRR or a PRR or proteinuria ≤ 1.5g/d (or UP/UC ≤ 1.5) after at least 6
    months of induction treatment (either with SOC (CYC or MMF-based) or SOC in
    combination with other available therapies used for induction treatment of LN e.g.
    tacrolimus, cyclosporin, experimental drug etc.); and within 12 months after initiating
    induction therapy outside of 1293.10 trial.
    - Steroid dose ≤ 15 mg/d prednisone-equivalent at baseline.
    E.4Principal exclusion criteria
    Evidence of current or previous clinically significant diseases or medical conditions
    other than lupus, or findings of the medical examination (including vital signs and ECG)
    that, in the opinion of the investigator, would compromise the safety of the patient or the
    quality of the data. This criterion provides an opportunity for the investigator to exclude
    patients based on clinical judgment, even if other eligibility criteria are satisfied.
    - Significant central nervous system symptoms related to SLE based on investigators
    assessment.
    - Clinically important acute or chronic infections including but not limited to HIV,
    hepatitis B or C.
    - Impaired hepatic function defined as serum AST/ALT, bilirubin or alkaline phosphatase
    > 2 x ULN.
    - Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 at screening (using
    CKD-EPI formula).
    - Known hypersensitivity to any constituents of the trial medication; and/or
    contraindications to MMF or AZA or glucocorticoids.
    - The use of any restricted medications (see section 4.2.3.1) or any drug considered likely
    to interfere with the safe conduct of the trial.
    - Unable to comply with the protocol in the investigator’s opinion.
    - Chronic alcohol or drug abuse or any condition that, in the investigator’s opinion, makes
    them an unreliable trial patient or unlikely to complete the trial.
    - Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
    For Group 2 patients only:
    - Clinically significant current non-SLE related renal diseases based on investigator’s
    judgment (e.g. post–infectious glomerulonephritis, pyelonephritis, interstitial nephritis,
    glomerulosclerosis).
    - Dialysis within 12 months of screening.
    - Live vaccination within 6 weeks prior to randomisation.
    - Antiphospholipid syndrome defined as positive antiphospholipid antibodies and either
    history of any thrombotic event or history of miscarriage.
    - Diabetes mellitus if poorly controlled or accompanied by known diabetic retinopathy or
    diabetic nephropathy. It is in the investigator’s judgment if the diabetes is sufficiently controlled for the patient to enter the trial.
    - With regard to previous induction treatments, the following applies:
    - Treatment with tacrolimus or cyclosporine or mizoribine within 1 month prior to
    randomisation.
    - Treatment with belimumab or other “BLyS antagonists” or another investigational
    drug within 3 months or 5 half-lives, whichever is greater, prior to randomisation.
    - Treatment with abatacept or cyclophosphamide within 3 months prior to
    randomisation.
    - Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20) within 6
    months prior to randomisation.
    - Are not eligible according to the following tuberculosis (TB) screening criteria:
    - Have signs or symptoms suggestive of current active or latent TB upon medical
    history, physical examination and/or a chest radiograph (both posterior-anterior and
    lateral views, taken within 3 months prior to the first administration of study drug and
    read by a qualified radiologist).
    -- Have history of latent or active TB prior to screening, except for patients who have
    documentation of having completed an adequate treatment regimen according to local
    guidelines within the past 3 years and at least 6 months prior to the first
    administration of study drug.
    -- Have positive QuantiFERON-TB Gold In-Tube test within 2 months prior to or
    during screening, in which latent or active TB has not been ruled out, except for
    patients with history of TB and documentation of having completed an adequate
    treatment regimen at least 6 months prior to the first administration of study drug.
    - Any documented active or suspected malignancy or history of malignancy within 5 years
    prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ
    carcinoma of uterine cervix.
    - Previous enrolment in 1293.10 and did not complete the trial.
    E.5 End points
    E.5.1Primary end point(s)
    1) proportion of patients with complete renal reponse (CRR) and without any renal flares
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) week 52
    E.5.2Secondary end point(s)
    1) Proportion of patients with proteinuria <0.8g/d and without any renal flares at week 52.
    2) Proportion of patients with CRR at week 52 and sustained steroid reduction to ≤5 mg/d from week 26 to week 52.
    3) Proportion of patients experiencing at least one renal flare during 52 weeks.
    4) Time to first renal flare over the course of 52 weeks.
    5) Change from baseline in SLEDAI at weeks 12, 26, 42 and 52.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) week 52
    2) week 52
    3) week 52
    4) week 52
    5) weeks 12, 26, 42 and 52
    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) 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Australia
    Austria
    Canada
    Czech Republic
    France
    Germany
    Greece
    Hong Kong
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Philippines
    Poland
    Portugal
    Serbia
    Spain
    Thailand
    Turkey
    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 years3
    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 years4
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days7
    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: 120
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 150
    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)
    None
    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 Decision2019-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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