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    Summary
    EudraCT Number:2017-000889-29
    Sponsor's Protocol Code Number:CLNP023X2202
    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:2018-12-17
    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 number2017-000889-29
    A.3Full title of the trial
    An open-label, non-randomized study on efficacy, pharmacokinetics, pharmacodynamics, safety and tolerability of LNP023 in two patient populations with C3 glomerulopathy
    Etude non randomisée, en ouvert, portant sur l'efficacité, la pharmacocinétique, la pharmacodynamie, la sécurité d’emploi et la tolérance du LNP023 chez deux populations de patients atteints de glomérulopathie C3
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on efficacy and safety of LNP023 in C3 glomerulopathy patients transplanted and not transplanted
    Etude sur l'efficacité et la sécurité d’emploi du LNP023 chez des patients
    atteints de glomérulopathie C3 transplantés ou
    A.4.1Sponsor's protocol code numberCLNP023X2202
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForum 1, Novartis Campus
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number41613241111
    B.5.5Fax number41613248001
    B.5.6E-mailclinicaltrialenquiries@novartis.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.3.2Product code LNP023 hydrochloride
    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 INNnot yet established
    D.3.9.1CAS number 1646321-63-2
    D.3.9.3Other descriptive name LNP023 hydrochloride
    D.3.9.4EV Substance CodeSUB180361
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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.3.2Product code LNP023 hydrochloride
    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 INNnot yet established
    D.3.9.1CAS number 1646321-63-2
    D.3.9.3Other descriptive name LNP023 hydrochloride
    D.3.9.4EV Substance CodeSUB180361
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.IMP: 3
    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.3.2Product code LNP023 hydrochloride
    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 INNnot yet established
    D.3.9.1CAS number 1646321-63-2
    D.3.9.3Other descriptive name LNP023 hydrochloride
    D.3.9.4EV Substance CodeSUB180361
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    C3 glomerulopathy
    Glomérulopathie C3
    E.1.1.1Medical condition in easily understood language
    Kidney disorder
    Maladie rénale
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Cohort A: To evaluate the efficacy of LNP023 in reducing proteinuria at Week 12
    • Cohort B: To assess histopathological changes in kidney biopsies at Week 12
    • Cohorte A : Evaluer l'efficacité du LNP023 sur la réduction de la protéinurie à la semaine 12
    • Cohorte B : Evaluer les modifications histopathologiques des biopsies rénales à la semaine 12
    E.2.2Secondary objectives of the trial
    • All Cohorts: To assess the relationship between LNP023 dose and
    proteinuria
    • All Cohorts: To assess the effect of LNP023 on renal function
    • All Cohorts: To assess the effect of LNP023 on alternative
    complement pathway hyperactivity
    • All Cohorts: To assess the safety and tolerability of LNP023
    • All Cohorts: To assess the plasma and urine pharmacokinetics of
    LNP023 in patients with C3G
    • Cohort B: To evaluate the efficacy of LNP023 in reducing proteinuria
    at Week 12
    • Toutes les cohortes : Evaluer la relation entre la dose de LNP023 et la protéinurie
    • Toutes les cohortes : Evaluer l'effet du LNP023 sur la fonction rénale
    • Toutes les cohortes : Evaluer l'effet du LNP023 sur l'hyperactivité de la voie alterne du complément
    • Toutes les cohortes : Evaluer les profils de sécurité d’emploi et de tolérance du LNP023
    • Toutes les cohortes : Evaluer la pharmacocinétique plasmatique et urinaire du LNP023 chez les patients C3G
    • Cohorte B : Evaluer l'efficacité du LNP023 surla réduction de la protéinurie à la semaine 12
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Cohort A and B:
    - Written informed consent must be obtained before any assessment is performed
    - Male and female patients between the ages of 18 to 65 (inclusive) at screening
    - C3G patients with proteinuria
    - Able to communicate well with the investigator, to understand and comply with the requirements of the study
    - At screening and baseline visits, patients must weigh at least 35 kg
    - Supine vital signs should be within the following ranges: oral body temperature between 35.0-37.5 °C systolic blood pressure, 80-170 mm Hg diastolic blood pressure, 50-105 mm Hg pulse rate, 45 - 100 bpm .

    Cohort A:
    - Estimated GFR (using the CKD-EPI formula) or measured GFR ≥30mL/min per 1.73 m2 for patients on a maximum recommended or maximum tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)
    - UPCR ≥ 100 mg/mmol (equivalent to ≥ 1 g/24h total urinary protein excretion)
    - Prior to entry, all patients must have been on supportive care including a maximally tolerated dose of ACEi or ARB for at least 30 days.

    Cohort B:
    - No histological/laboratory/clinical signs of allorejection
    - If applicable, induction treatment after allotransplantation needs to be completed >30 days before inclusion.
    - Transplantation of a kidney allograft >90 days before inclusion
    - Patients need to be on a stable dose of immunsuppressive regimen prior to inclusion. Any approved treatments are allowed for this purpose.
    Cohortes A et B :
    - Recueil du consentement éclairé par écrit avant toute évaluation.
    - Hommes et femmes âgés de 18 à 65 ans (inclus) à la sélection.
    - Patients présentant une GC3 avec protéinurie
    -Être en mesure de bien communiquer avec l'investigateur, de comprendre et respecter les exigences de l'étude.
    - Lors des visites de sélection et de base, les patients doivent peser au moins 35 kg
    - Les signes vitaux en position allongée doivent se situer dans
    les limites suivantes : température corporelle orale entre 35,0 et 37,5°C ; pression artérielle systolique 80-170 mm Hg, pression artérielle diastolique 50-105 mm Hg, fréquence cardiaque 45-100 bpm.

    Cohorte A :
    - DFG estimé (à l’aide de la formule CKD-EPI) ou DFG mesuré ≥ 30 ml/min par 1,73 m2 pour les patients recevant une dose maximale recommandée ou une dose maximale tolérée d'un inhibiteur de l'enzyme de conversion de l'angiotensine (IEC) ou d'un antagoniste des récepteurs de l'angiotensine (ARA).
    - RPCU ≥ 100 mg/mmol (équivalent à une excrétion totale de protéines urinaires ≥ 1 g/24 h)
    - Avant l'entrée dans l'étude, tous les patients doivent avoir reçu des traitements de soutien, notamment une dose maximale tolérée d'IEC ou d'ARA pendant au moins 30 jours.

    Cohorte B :
    - Aucun signe histologique/biologique/clinique de rejet de greffe allogénique.
    - Le cas échéant, le traitement d'induction après l'allotransplantation doit être terminé > 30 jours avant l'inclusion.
    - Transplantation d'une allogreffe rénale > 90 jours avant l'inclusion dans l'étude.
    - Les patients doivent avoir reçu une dose stable d’un traitement immunosuppresseur avant l'inclusion dans l'étude. Tout traitement approuvé est autorisé à cette fin.
    E.4Principal exclusion criteria
    Cohort A and B:
    - Use of other investigational drugs at the time of enrollment, or within 5 half-lives of randomization, or within 30 days, whichever is longer; or longer if required by local regulations
    - A history of clinically significant ECG abnormalities,
    - Known family history or known presence of long QT syndrome or Torsades de Pointes
    - Use of agents known to prolong the QT interval unless they can be permanently discontinued for the duration of the study
    - Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
    - Women of child bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping of investigational drug.
    - History of immunodeficiency diseases, or a positive HIV (ELISA and Western blot) test result.
    - Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV).
    - Patients who cannot receive vaccinations against N. meningitidis, S. pneumoniae, or H. influenzae
    Cohortes A et B :
    - Administration d’autres médicaments à l'essai au moment du recrutement ou dans les 5 demi-vies du médicament précédant la randomisation ou dans les 30 jours, selon la plus longue de ces deux
    durées, ou un délai plus long si les législations locales l’exigent.
    - Antécédents d’anomalies d’ECG cliniquement significatives
    - Antécédents familiaux connus ou présence connue du syndrome du QT long ou de torsades de pointes.
    - Utilisation de produits connus pour entraîner un allongement de l'intervalle QT, sauf s'il est possible de les arrêter définitivement pendant toute la durée de l'étude.
    - Grossesse ou allaitement au sein , la grossesse étant définie comme l'état de la femme après la conception et jusqu'au terme de la gestation, confirmée par un dosage biologique positif d'hCG
    - Les femmes en âge de procréer, à savoir toute femme physiologiquement apte à être enceinte, sauf si elles utilisent des méthodes de contraception très efficaces pendant toute la durée du traitement et pendant 1 semaine après l'arrêt du médicament à l'essai.
    - Antécédents de pathologies immunodéficitaires, ou résultat positif au dépistage du VIH (ELISA et Western blot).
    - Infection chronique par le virus de l'hépatite B (VHB) ou de l'hépatite C (VHC).
    - Patients ne pouvant pas recevoir de vaccins contre N. meningitidis, S. pneumoniae, ou H. influenzae.
    E.5 End points
    E.5.1Primary end point(s)
    Cohort A: Change from baseline in UPCR
    Cohort B: Change from baseline in C3 Deposit
    Cohorte A : variation par rapport aux valeurs initiales (baseline) du
    rapport protéine/créatinine urinaire (RPCU)
    Cohorte B : variation par rapport aux valeurs initiales du score de
    dépôt de C3
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semaine 12
    E.5.2Secondary end point(s)
    PD variables
    Pharmacokinetics variables
    Biomarker C3
    Biomarker Bb
    Données de pharmacodynamique (PD)
    Données de pharmacocinétiques (PK)
    Biomarqueurs C3
    Biomarqueurs Bb
    E.5.2.1Timepoint(s) of evaluation of this end point
    PD variables Week 12
    Pharmacokinetics variables Week 1, 2, 3, 4, 13, 14
    Biomarker C3 Week 1,2, 3, 4, and 12
    Biomarker Bb Week 1, 2, 3, 4 and 12
    PD : semaine 12
    PK : semaines 1, 2, 3, 4, 13, 14
    Biomarqueurs C3 : semaines 1, 2, 3, 4 et 12
    Biomarqueurs Bb : semaines 1, 2, 3, 4 et 12
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    France
    Germany
    Italy
    Spain
    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
    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 months6
    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 months6
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    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 22
    F.4.2.2In the whole clinical trial 27
    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)
    Extension study
    Etude 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 Decision2019-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-23
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