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    Summary
    EudraCT Number:2015-001750-15
    Sponsor's Protocol Code Number:1293.10
    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:2016-11-22
    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 number2015-001750-15
    A.3Full title of the trial
    A double-blind, randomised, placebo-controlled trial evaluating the effect of BI 655064 administered as sub-cutaneous injections, on renal response after one year treatment in patients with lupus nephritis
    Etude randomisée en double aveugle, contrôlée versus placebo, évaluant l’efficacité du BI 655064, administré par injections sous-cutanées, sur la réponse rénale au bout d’un an de traitement chez des patients atteints de néphropathie lupique active
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety of BI 655064 in patients with Lupus Nephritis
    Efficacité et sécurité d'emploi du BI 655064 chez des patients atteints de néphropathie lupique active
    A.3.2Name or abbreviated title of the trial where available
    POC in lupus nephrits
    Preuve de concept dans la néphropathie lupique
    A.4.1Sponsor's protocol code number1293.10
    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 Pharma 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 code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+1800243 0127
    B.5.5Fax number+1800821 7119
    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/ml
    D.3.4Pharmaceutical form Solution for injection 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.3.10 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/ml
    D.3.4Pharmaceutical form Solution for injection 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.3.10 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lupus Nephritis
    Néphropathie lupique
    E.1.1.1Medical condition in easily understood language
    Lupus nephritis
    Néphropathie lupique
    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 19.0
    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
    assess efficacy and safety of one year treatment with three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis
    Evaluer l’efficacité et la tolérance d'un an de traitement avec trois doses différentes de BI 655064 contre un placebo en ajout à un traitement conventionnel de la néphropathie lupique active
    E.2.2Secondary objectives of the trial
    assess the efficacy at 6 months
    Evaluer l'efficacité à 6 mois
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - males and females 18-70 years. Women of childbearing potential must be ready and able to use simultaneously two highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. The contraception should be used before starting MMF therapy and the study drug, during the treatment and until 6 weeks after stopping MMF and the study drug. Sexually active men must be ready to use condoms during treatment with MMF and for at least 90 days after cessation of MMF treatment.
    - Diagnosis of systemic lupus erythematosus (SLE) by ACR criteria 1997, at least 4 criteria must be documented, one of which must be a positive anti-dsDNA antibody at screening or around time of start of induction therapy
    - Lupus Nephritis Class III or IV (ISN/RPS 2003 classification) with either active or active/chronic disease, co-existing class V permitted, proven by renal biopsy within 3 months prior to screening or during screening if induction therapy has not yet been started
    - Active renal disease evidenced by proteinuria >= 1.0 g/day (Uprot/ucrea >= 100 mg/mmol)
    - Signed and dated written informed consent
    - Homme ou femme de 18 à 70 ans. Les femmes en âge de procréer doivent être prêtes et aptes à utiliser deux méthodes de contraception très efficaces selon la définition de l’ICH M3(R2), dont le taux d’échec est inférieur à 1 % par an quand elles sont utilisées constamment et correctement. Cette contraception doit être utilisée, avant de commencer le traitement avec le MMF et le médicament à l’étude et pendant le traitement jusqu’à 6 semaines après l’arrêt du MMF et du médicament à l’étude. Les hommes sexuellement actifs doivent être prêts à utiliser des préservatifs durant le traitement avec le MMF et durant au moins 90 jours après l’arrêt du MMF.
    - Diagnostic de lupus érythémateux disséminé (LED) selon les critères de 1997 de l’ACR ; au moins quatre critères doivent être documentés, dont un doit être la positivité pour des anticorps anti-ADN bicaténaire à la sélection ou aux alentours du démarrage du traitement d’induction.
    - Néphropathie lupique de classe III ou IV (classification ISN/RPS 2003) active ou active/chronique, classe V coexistante autorisée, confirmée par une biopsie rénale au cours des 3 mois précédant la sélection ou durant la sélection si un traitement d’induction n’a pas encore été instauré.
    - Néphropathie active démontrée par une protéinurie ≥ 1,0 g/jour (protéinurie/créatininurie ≥ 100 mg/mmol).
    - Consentement éclairé écrit signé et daté
    E.4Principal exclusion criteria
    - clinically significant current other renal disease
    - GFR<30ml/min/1.73m²
    - Acute presence of Oliguria (<500 mL/day)
    - dialysis within 12m of screening
    - Antiphospholipid syndrom
    - diabetes mellitus poorly controlled or known diabethic retinopathy or nephropathy
    - Evidence of current or previous clinically significant disease, medical condition or finding in the medical examination that in the investigator's opinion would compromise the safety of the patient or the quality of the data
    - Live vaccination within 6 weeks before randomisation
    - Any induction therapy for LN within the last 6 months prior to randomisation except induction with MMF and high dose steroids tarted within 4 weeks prior to randomisation
    - Treatment with any biologic B-cell depleting therapy (e.g. anti-CD20, anti-CD22, anti-BLyS) within 12 months prior to randomisation
    Treatment with abatacept within 12 months prior to randomisation
    Treatment with tacrolimus or cyclosporin within 4 weeks prior to randomisation
    Treatment with cyclophosphamid within 6 months prior to randomisation
    Treatment with investigational drug within 6 months or 5 half-lives, whichever is greater before randomisation
    - Contraindication for MMF or corticosteroids
    - Chronic or relevant acute infections, including but not limited to HIV, Hepatitis B and C and tuberculosis (including a history of clinical TB and/or a positive QuantiFERON TB-Gold test
    - Any active or suspected malignancy or history of documented malignancy within the last 5 years before screening, except appropriately treated carcinoma in situ and treated basal cell carcinoma.
    - Patients unable to comply with the protocol in the investigator¿s opinion.
    - Alcohol abuse in the opinion of the investigator or active drug abuse .
    - Women who are pregnant, nursing, or who plan to become pregnant while in the trial
    - Impaired hepatic function, defined as serum AST/ALT, bilirubin or alkaline phosphatase levels > 2 x ULN
    - Présence d’une autre affection rénale cliniquement significative
    - DFG < 30 ml/min/1,73 m² à la sélection.
    - Présence d’une oligurie aiguë (< 500 ml/jour).
    - Dialyse au cours des 12 mois précédant la sélection.
    - Syndrome des antiphospholipides
    - Diabète sucré, s’il est mal contrôlé, ou rétinopathie ou néphropathie diabétique connue.
    - Signes de maladie actuelle ou précédente cliniquement significative, affection médicale autre que le lupus ou résultats de l’examen clinique qui, selon le jugement de l’investigateur, compromettraient la sécurité du patient ou la qualité des données.
    -Tout traitement d’induction pour la NL au cours des 6 mois précédant la randomisation, sauf induction par MMF et corticothérapie à forte dose instaurée au cours des 4 semaines précédant la randomisation,
    - Traitement par tout agent réduisant les populations de lymphocytes B (par exemple anti-CD20, anti-CD22, anti-BLyS) au cours des 12 mois précédant la randomisation,
    - Traitement par abatacept au cours des 12 mois précédant la randomisation,
    - Traitement par tacrolimus ou ciclosporine au cours des 4 semaines précédant la randomisation
    - Traitement par cyclophosphamide au cours des 6 mois précédant la randomisation
    - Traitement par un médicament expérimental dans les 6 mois ou de 5 demi-vies, selon la plus longue de ces durées, avant la randomisation.
    - Contre-indication au MMF ou corticoïdes.
    - Patients ayant reçu un vaccin vivant dans les 6 semaines avant la randomisation.
    - Infection aiguë ou chronique importante, incluant mais non limité au VIH ou au virus de l’hépatite B ou C et la tuberculose (incluant des antécédents cliniques de TB et/ou un test QuantiFERON TB-Gold positif)
    - Toute affection maligne active ou suspectée ou antécédents d’affection maligne au cours des 5 ans précédant la sélection, sauf carcinome in situ et carcinome basocellulaire ou épidermoïde de la peau adéquatement traité.
    - Patient ne pouvant se conformer aux exigences du protocole, selon le jugement de l’investigateur.
    - Abus d’alcool ou abus de drogue en cours selon le jugement de l’investigateur.
    - Femme enceinte, qui allaite ou qui projette de débuter une grossesse au cours de sa participation à l’essai.
    - Altération de la fonction hépatique, définie comme un taux sérique d’ASAT/ALAT, de bilirubine ou de phosphatase alcaline > 2 x la limite supérieure de la normale.
    E.5 End points
    E.5.1Primary end point(s)
    1: proportion of patients with complete renal response
    1: proportion des patients présentant une réponse rénale complète
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: week 52
    1: semaine 52
    E.5.2Secondary end point(s)
    1: proportion of patients with complete renal response
    2: proportion of patients with partial renal response
    3: proportion of patients with major renal response
    1: Proportion des patients présentant une réponse rénale complète
    2: Proportion des patients présentant une réponse rénale partielle
    3: Proportion des patients présentant une réponse rénale majeure
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: week 26
    2: week 26 and 52
    3: week 26 and 52
    1: semaine 26
    2: semaines 26 et 52
    3: semaines 26 et 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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Poland
    Portugal
    Singapore
    Spain
    Thailand
    Turkey
    United Kingdom
    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
    Dernière visite du dernier patient
    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 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 months2
    E.8.9.2In all countries concerned by the trial days11
    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.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: 109
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 11
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 91
    F.4.2.2In the whole clinical trial 160
    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)
    patients with at least partial response could enter an extension trial
    Les patients ayant au moins une réponse partielle pourront rentrer dans l'étude d'extension
    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 Decision2016-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-08-18
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