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    EudraCT Number:2019-004778-25
    Sponsor's Protocol Code Number:AIE001
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-16
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2019-004778-25
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
    Étude de phase 2 multicentrique, randomisee, en double insu, controlee contre placebo, evaluant l’efficacite, la tolerance et la pharmacocinetique du rozanolixizumab chez des adultes atteints d’encephalite auto-immune a anticorps anti-lgi1 (leucine-rich glioma inactivated 1)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the efficacy, safety, and pharmacokinetics of rozanolixizumab in adult study participants with Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
    Étude de phase 2 évaluant l’efficacité et la tolérance du rozanolixizumab chez des adultes atteints d’encéphalite auto-immune à anticorps anti-LGI1 (leucine-rich glioma inactivated 1)
    A.4.1Sponsor's protocol code numberAIE001
    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 SponsorUCB Biopharma SRL
    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 supportUCB Biopharma SRL
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCB BIOSCIENCES GmbH
    B.5.2Functional name of contact pointClin Trial Reg & Results Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressAlfred-Nobel-Strasse 10
    B.5.3.2Town/ cityMonheim
    B.5.3.3Post code40789
    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 nameRozanolixizumab
    D.3.2Product code UCB7665
    D.3.4Pharmaceutical form Solution for infusion
    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 INNRozanolixizumab
    D.3.9.1CAS number 1584645-37-3
    D.3.9.2Current sponsor codeUCB7665
    D.3.9.3Other descriptive nameUCB7665
    D.3.9.4EV Substance CodeSUB166282
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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. 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 Yes
    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 placeboSolution for infusion
    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
    Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
    Encéphalite auto-immune à anticorps anti-LGI1 (leucine-rich glioma inactivated 1)
    E.1.1.1Medical condition in easily understood language
    Autoimmune encephalitis comprises a group of immune system-mediated conditions whereby the individual's immune cells erroneously target healthy cells in the nervous system including brain cells.
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10072378
    E.1.2Term Encephalitis autoimmune
    E.1.2System Organ Class 10029205 - Nervous system 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 the efficacy of rozanolixizumab as measured by seizure freedom
    Évaluer l’efficacité du rozanolixizumab d’après la mesure des périodes sans crises
    E.2.2Secondary objectives of the trial
    -Assess the efficacy of rozanolixizumab as measured by a change in cognitive function
    -Assess the efficacy of rozanolixizumab as measured by use of rescue medication
    -Assess the efficacy of rozanolixizumab as measured by the onset of seizure freedom
    -Assess the safety and tolerability of rozanolixizumab
    -Évaluer l’efficacité du rozanolixizumab d’après la mesure des modifications de la fonction cognitive
    -Évaluer l’efficacité du rozanolixizumab d’après la mesure de l’utilisation de médicament de secours
    -Évaluer l’efficacité du rozanolixizumab d’après la mesure de l’apparition de périodes sans crises
    -Évaluer la tolérance et la sécurité d’emploi du rozanolixizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Study participant must be ≥18 to ≤89 years of age, at the time of signing the informed consent
    -Study participant must be seropositive for leucine-rich glioma inactivated 1 (LGI1) antibody measured by LGI1 serum autoantibody cell-binding assay
    -Study participant must have faciobrachial dystonic seizures (FBDS) and/or other partial [focal] seizures with or without secondary generalization (≥2 seizures/week) during the Screening Period, or have experienced such seizures that stopped as a result of intravenous
    methylprednisolone (IVMP) initiation
    -Study participant is currently considered for treatment with IVMP by the investigator or has initiated IVMP treatment at a dose of 500 to 1000 mg/day within 14 days prior to randomization. If the study participant has initiated a steroid taper, the study participant cannot be receiving an
    oral steroid dose lower than 60 mg/day when randomized
    -Study participant with onset of disease between 0 to 12 months prior to Screening
    -Study participant weighs at least 35 kg (for males and females) at Screening
    −A male participant must agree to use contraception during the treatment period and for at least 90 days after the final dose of study treatment and refrain from donating sperm during this period
    −A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
    i) Not a woman of childbearing potential (WOCBP)
    ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 90 days after the final dose of study treatment
    -Âge compris entre ≥ 18 et ≤ 89 ans au moment de la signature du formulaire de consentement éclairé
    -Séropositivité aux anti-LGI1, mesurée par un test de liaison cellulaire des auto-anticorps sérique anti- LGI1.
    -Présence de crises dystoniques brachio-faciales (FBDS, faciobrachial dystonic seizure(s)) et/ou d’autres crises [focales] partielles avec ou sans généralisation secondaire (≥ 2 crises/semaine) pendant la période de sélection ou antécédents de crises de ce type, qui se sont arrêtées en raison de l’instauration de la MPIV.
    -Traitement MPIV envisagé pour le participant (la participante) à l’étude par l’investigateur ou instauration d’un traitement par MPIV à une dose de 500 à 1 000 mg/jour dans les 14 jours avant la randomisation. Si le participant (la participante) à l’étude a commencé la diminution progressive des corticoïdes, il (elle) ne pourra pas recevoir de corticoïdes oraux à une dose inférieure à 60 mg/jour lorsqu’il (elle) sera randomisé(e).
    -Apparition de la maladie entre 0 et 12 mois avant la sélection.
    -Poids minimum de 35 kg (pour les hommes et les femmes) à la sélection
    -Un homme participant à l’étude doit accepter d’utiliser les moyens de contraception pendant la période de traitement et pendant au moins 90 jours après la dose finale de traitement à l’étude, et de ne pas donner de sperme pendant cette période.
    − Une participante est éligible pour participer si elle n’est pas enceinte, n’allaite pas et qu’au moins une des conditions suivantes est applicable :
    i) La participante n’est pas une femme en âge de procréer (FAP)
    ii)La participante est une FAP qui accepte de suivre les recommandations relatives à la contraception pendant la période de traitement et pendant au moins 90 jours après la dose finale de traitement à l’étude.
    E.4Principal exclusion criteria
    -Study participant has a known hypersensitivity to any components of the study medication or any other anti-neonatal Fc receptor (FcRn) medications. This includes a known history of hyperprolinemia, since L-proline is a constituent of the rozanolixizumab formulation
    -Study participant has a confirmed prior diagnosis of epilepsy that is unrelated to LGI1 autoimmune encephalitis (AIE)
    -Study participant has active neoplastic disease or history of neoplastic disease within 5 years of study entry (except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix which has been definitively treated with standard of care approaches)
    -Study participant has 12-lead electrocardiogram (ECG) with findings considered clinically significant upon medical review
    -Study participant has current unstable liver or biliary disease, per investigator assessment, defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis
    -Study participant has positive tuberculosis (TB) test at the Screening Visit
    -Study participant has any of the following active gastrointestinal (GI) disorders: inflammatory bowel disease, GI ulceration, or diverticulitis
    -Study participant has a history of solid organ transplant or hematopoietic stem cell transplant
    -Study participant has undergone a splenectomy
    -Study participant has a current or medical history of primary immune deficiency
    -Study participant has been treated with prohibited immunosuppressants, biologics, and other therapies
    -Study participant has received a live vaccination within 8 weeks prior to the Baseline Visit; or intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of investigational medicinal product (IMP)
    -Study participant has previously received rozanolixizumab drug product
    -Alanine transaminase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) are >2x upper limit of normal (ULN)
    -Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 %)
    -Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
    -For randomized study participants with a Baseline result >ULN for ALT, AST, ALP, or total bilirubin but <1.5xULN, a Baseline diagnosis and/or the cause of any clinically meaningful elevation will have to be understood and recorded in the electronic case report form (eCRF)
    -If study participant has >ULN for ALT, AST, or ALP that does not meet the exclusion limit at Screening, the tests should be repeated, if possible, prior to dosing to ensure there was no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the study participants will have to be discussed with the medical monitor
    -Tests that result in ALT, AST, or ALP up to 25 % above the exclusion limit (>2xULN) will have to be repeated once for confirmation. This includes rescreening
    -Study participant has an IgG level ≤5.5 g/L at the Screening Visit
    -Study participant has absolute neutrophil count <1500 cells/mm^3 at the Screening Visit
    -Participant has QT interval corrected for heart rate using Fridericia’s formula (QTcF) >450 msec (for male participants) or QTcF >470 msec (for female participants) or QTcF >480 msec in participants with bundle branch block
    -Hypersensibilité connue à l’un des composants du médicament à l’étude ou tout autre médicament anti-FcRn. Cela inclut des antécédents connus d’hyperprolinémie, puisque la L-proline est un des composants de la formulation du rozanolixizumab.
    -Antécédents épileptiques confirmés, non liés à l’EAI LGI1.
    -Présence ou antécédents de pathologie néoplasique dans les 5 ans précédant l’entrée dans l’étude (autre que carcinome basocellulaire ou épidermoïde de la peau ou carcinome in situ du col de l’utérus, définitivement traité par des approches thérapeutiques de référence).
    -Électrocardiogramme (ECG) à 12 dérivations présentant des anomalies considérées comme cliniquement significatives à l’examen médical
    -Pathologie hépatique ou biliaire instable en cours, selon l’évaluation des investigateurs, définie par la présence d’une ascite, d’une encéphalopathie, d’une coagulopathie, d’une hypoalbuminémie, de varices oesophagiennes ou gastriques, d’un ictère persistant ou d’une cirrhose.
    -Résultat positif au test de dépistage de la TB à la visite de sélection.
    -Présence de n’importe laquelle des pathologies GI actives suivantes : maladie intestinale inflammatoire, ulcère GI ou diverticulite.
    -Antécédents de greffe d’organe solide ou de greffe de cellules souches hématopoïétiques.
    -Antécédents de splénectomie.
    -Présence ou antécédents médicaux d’immunodéficience primitive.
    -Antécédents de traitement par immunosuppresseurs, agents biologiques et autres traitements
    -Antécédents d’administration d’un vaccin vivant dans les 8 semaines précédant la visite d’inclusion ou administration prévue d’un vaccin vivant pendant l’étude ou dans les 8 semaines suivant la dose finale de ME.
    -Antécédents de traitement par rozanolixizumab
    -Taux d’alanine aminotransférase (ALAT), d’aspartate aminotransférase (ASAT), de phosphatases alcalines (PAL) > 2 x limite supérieure de la normale (LSN)
    -Bilirubine > 1,5 x LSN (une bilirubine isolée > 1,5 x LSN est acceptable si la bilirubine est fractionnée et que la bilirubine directe est < 35 %)
    -Présence ou antécédents de pathologie hépatique chronique ou anomalies hépatiques ou biliaires connues (à l’exception du syndrome de Gilbert ou des lithiases biliaires asymptomatiques)
    -Pour les participants à l’étude randomisés avec un résultat initial > LSN pour les taux d’ALAT, ASAT, PAL ou bilirubine totale mais < 1,5 x LSN, un diagnostic initial et/ou la cause de toute élévation cliniquement significative doi(ven)t être établi(s) et enregistré(s) dans le cahier d’observation électronique (eCRF)
    -Si le participant (la participante) présente un taux d’ALAT, ASAT ou PAL >LSN ne répondant pas à la limite de non-inclusion à la sélection, il convient de répéter le dosage, si possible, avant l’administration du traitement, pour s’assurer qu’il n’y a plus d’augmentation cliniquement significative en cours. En cas d’augmentation cliniquement significative, l’inclusion du (de la) participant(e) à l’étude devra être discutée avec le moniteur médical
    -Les dosages montrant des taux d’ALAT, ASAT ou PAL jusqu’à 25 % supérieurs à la limite de non-inclusion (> 2 x LSN) devront être répétés une fois pour confirmation. Cela inclut une re-sélection.
    -Taux d’IgG ≤ 5,5 g/l à la visite de sélection
    -Numération absolue des neutrophiles < 1500 cellules/mm3 à la visite de sélection
    -Intervalle QT corrigé par rapport à la fréquence cardiaque à l’aide de la formule de Fridericia (QTcF) > 450 msec (pour les hommes participant à l’étude) ou QTcF > 470 msec (pour les femmes participant à l’étude) ou QTcF > 480 msec chez les participants ayant un bloc de branches

    21. Antécédents de randomisation du participant (de la participante) à l’étude dans la présente étude (la re-sélection pour les participants en échec de sélection est autorisée après consultation préalable et autorisation du moniteur médical

    E.5 End points
    E.5.1Primary end point(s)
    Proportion of seizure free study participants at the end of the Treatment Period
    Proportion de participants à l'étude sans crise à la fin de la période de traitement
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline until the end of Treatment Period (Week 25)
    Par rapport valeurs initiales jusqu'à la fin de la période de traitement (Semaine 25)
    E.5.2Secondary end point(s)
    1. Change from Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total scale index score at the end of the Treatment Period
    2. Proportion of participants who required rescue medication due to an absence or loss of clinical benefit during the Treatment Period
    3. Time to first occurrence of seizure freedom during the Treatment Period
    4. Incidence of Treatment-Emergent Adverse Events (TEAEs)
    1. Modification, par rapport aux valeurs initiales, du score indice total de l’échelle RBANS (Repeatable Battery for the Assessment of Neuropsychological Status, Batterie répétable pour l’évaluation de l’état neuropsychologique) à la fin de la période de traitement
    2. Proportion de participants ayant eu besoin de médicament de secours due à une absence ou une perte d’effet bénéfique clinique pendant la période de traitement
    3. Délai avant la première survenue d’une période sans crises (TTFSF, Time to first occurrence of seizure freedom) pendant la période de traitement
    4. Incidence des événements indésirables apparaissant sous traitement (EIAT)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-3: From Baseline until the end of the Treatment Period (Week 25)
    4: From Baseline until the End of Study Visit (Week 32)
    1-3: Par rapport valeurs initiales jusqu'à la fin de la période de traitement (Semaine 25)
    4. Par rapport valeurs initiales jusqu'à la visite de fin d’étude (Semaine 32)
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability and Immunogenicity
    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 concerned4
    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
    Korea, Republic of
    United States
    United Kingdom
    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
    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 months9
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days24
    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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 68
    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)
    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 Decision2021-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-20
    P. End of Trial
    P.End of Trial StatusOngoing
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