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    EudraCT Number:2019-004778-25
    Sponsor's Protocol Code Number:AIE001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-08
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    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
    Studio di Fase 2 multicentrico, randomizzato, in doppio cieco, controllato con placebo, per valutare l’efficacia, la sicurezza e la farmacocinetica di rozanolixizumab in partecipanti allo studio adulti affetti da encefalite autoimmune associata agli anticorpi anti-LGI1 (glioma inattivato 1 ricco di leucina)
    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
    Studio per valutare l’efficacia, la sicurezza e la farmacocinetica di rozanolixizumab in partecipanti allo studio adulti affetti da encefalite autoimmune con glioma inattivato 1 ricco di leucina
    A.3.2Name or abbreviated title of the trial where available
    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 Biophama 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.3.9.4EV 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 Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Encefalite autoimmune con glioma inattivato 1 ricco di leucina)
    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.
    L'encefalite autoimmune comprende un gruppo di malattie mediate dal sistema immunitario dove le cellule del sistema immunitario dell'individuo colpisco erroneamente le cellule del sistema nervoso,...
    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
    Valutare l’efficacia di rozanolixizumab misurata in base all’assenza di crisi convulsive
    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
    - Valutare l’efficacia di rozanolixizumab misurata in base a un cambiamento della funzione cognitiva
    - Valutare l’efficacia di rozanolixizumab misurata in base all’uso di farmaci di soccorso
    - Valutare l’efficacia di rozanolixizumab misurata in base all’esordio dell’assenza di crisi convulsive
    - Valutare la sicurezza e la tollerabilità di rozanolixizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Study participant must be >or= 18 to <or= 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 facio-brachial dystonic seizures (FBDS) and/or other partial [focal] seizures with or without secondary generalization (>or= 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 1000mg/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
    - Il partecipante allo studio deve avere un'età compresa tra > o= 18 e < o= 89 anni, al momento della firma del consenso informato
    - Il partecipante allo studio deve essere sieropositivo per l'anticorpo glioma inattivato 1 ricco di leucina (LGI1) misurato tramite il test di legame cellulare dell'autoanticorpo LGI1 nel siero
    - Il partecipante allo studio deve avere crisi distoniche facio-brachiali (FBDS) e/o altre crisi parziali [focali] con o senza generalizzazione secondaria (> o= 2 crisi/settimana) durante il periodo di screening, o aver avuto tali crisi che sono cessate in seguito all'inizio del metilprednisolone endovenoso (IVMP)
    - Il partecipante allo studio è attualmente impegnato in un trattamento con IVMP da parte dello sperimentatore o ha iniziato un trattamento con IVMP ad una dose da 500 a 1000 mg/die nei 14 giorni precedenti la randomizzazione. Se il partecipante allo studio ha iniziato un trattamento con steroidi, il partecipante allo studio non può ricevere una dose di steroidi orali inferiore a 60 mg/giorno al momento della randomizzazione
    - Partecipante allo studio con inizio della malattia tra 0 e 12 mesi prima dello screening
    - Il partecipante allo studio pesa almeno 35 kg (per maschi e femmine) allo screening
    - Un partecipante maschio deve accettare di usare la contraccezione durante il periodo di trattamento e per almeno 90 giorni dopo l'ultima dose di trattamento dello studio e astenersi dal donare lo sperma durante questo periodo
    - Una partecipante di sesso femminile è idonea a partecipare se non è incinta, non sta allattando e se si applica almeno una delle seguenti condizioni
    i) non è una donna in età fertile (WOCBP)
    ii) una WOCBP che accetta di seguire le indicazioni contraccettive durante il periodo di trattamento e per almeno 90 giorni dopo la dose finale del trattamento dello studio
    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 bilirubinis 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 < or = 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
    - Il partecipante allo studio ha un'ipersensibilità nota a qualsiasi componente del farmaco in studio o a qualsiasi altro farmaco del recettore Fc anti-neonatale (FcRn). Questo include una storia nota di iperprolinemia, poiché la L-prolina è un componente della formulazione di rozanolixizumab
    - Il partecipante allo studio ha una precedente diagnosi confermata di epilessia non correlata all'encefalite autoimmune (AIE) LGI1
    - Il partecipante allo studio ha una malattia neoplastica attiva o una storia di malattia neoplastica entro 5 anni dall'inizio dello studio (eccetto il carcinoma basale o squamoso della pelle o il carcinoma in situ della cervice uterina che è stato definitivamente trattato con approcci standard di cura)
    - Il partecipante allo studio ha un elettrocardiogramma a 12 derivazioni (ECG) con risultati considerati clinicamente significativi dopo la revisione medica
    - Il partecipante allo studio ha una malattia epatica o biliare instabile, secondo la valutazione dello sperimentatore, definita dalla presenza di ascite, encefalopatia, coagulopatia, ipoalbuminemia, varici esofagee o gastriche, ittero persistente o cirrosi
    - Il partecipante allo studio è positivo al test per la tubercolosi (TB) alla visita di screening
    - Il partecipante allo studio ha uno dei seguenti disturbi gastrointestinali (GI) attivi: malattia infiammatoria intestinale, ulcerazione GI o diverticolite
    - Il partecipante allo studio ha una storia di trapianto di organi solidi o di cellule staminali ematopoietiche
    - Il partecipante allo studio ha subito una splenectomia
    - Il partecipante allo studio ha una storia attuale o medica di immunodeficienza primaria
    - Il partecipante allo studio è stato trattato con immunosoppressori, biologici e altre terapie vietate
    - Il partecipante allo studio ha ricevuto una vaccinazione viva nelle 8 settimane precedenti la visita di riferimento; o intende sottoporsi a una vaccinazione viva nel corso dello studio o nelle 8 settimane successive alla dose finale del medicinale in fase di sperimentazione (IMP)
    - Il partecipante allo studio ha ricevuto in precedenza il prodotto farmaceutico rozanolixizumab
    - Alanina transaminasi (ALT), aspartato aminotransferasi (AST), o fosfatasi alcalina (ALP) sono >2x limite superiore della norma (ULN)
    - Bilirubina >1.5xULN (la bilirubina isolata >1.5xULN è accettabile se la bilirubina è frazionata e la bilirubina diretta <35%)
    - Storia attuale o cronica di malattia epatica, o anomalie epatiche o biliari note (con l'eccezione della sindrome di Gilbert o dei calcoli asintomatici)
    - Per i partecipanti allo studio randomizzati con un risultato al basale >ULN per ALT, AST, ALP, o bilirubina totale ma <1,5xULN, una diagnosi al basale e/o la causa di qualsiasi aumento clinicamente significativo dovrà essere compresa e registrata nel modulo elettronico di segnalazione dei casi (eCRF)
    - Se il partecipante allo studio ha >ULN per ALT, AST o ALP che non soddisfa il limite di esclusione allo screening, i test devono essere ripetuti, se possibile, prima del dosaggio per garantire che non ci sia stato un ulteriore aumento clinicamente rilevante in corso. In caso di un aumento clinicamente rilevante, l'inclusione dei partecipanti allo studio dovrà essere discussa con il medico di controllo
    - I test che risultano in ALT, AST o ALP fino al 25% sopra il limite di esclusione (>2xULN) dovranno essere ripetuti una volta per conferma. Questo include il rescreening
    - Il partecipante allo studio ha un livello di IgG < o = 5,5 g/L alla visita di screening
    - Il partecipante allo studio ha una conta assoluta dei neutrofili <1500 cellule/mm^3 alla visita di screening
    - Il partecipante ha un intervallo QT corretto per la frequenza cardiaca usando la formula di Fridericia (QTcF) >450 msec (per i partecipanti maschi) o QTcF >470 msec (per le partecipanti femmine) o QTcF >480 msec nei partecipanti con blocco di branca
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of seizure free study participants at the end of the Treatment Period
    Proporzione di partecipanti allo studio senza crisi convulsive fino alla fine del periodo di trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline until the end of Treatment Period (Week 25)
    Dal basale fino alla fine del periodo di trattamento (Settimana 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. Variazione rispetto al basale del punteggio totale dell’indice della scala di valutazione dello stato neuropsicologico (RBANS) alla fine del periodo di trattamento
    2. Proporzione di partecipanti che hanno richiesto l'uso di farmaci di soccorso dovuto ad assenza o perdita di beneficio clinico durante il periodo di trattamento
    3. Tempo alla prima manifestazione di assenza di crisi convulsive durante il periodo di trattamento
    4. Incidenza di eventi avversi emergenti dal trattamento (TEAE)
    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: Dal Basale fino alla fine del periodo di trattamento (Settimana 25)
    4: Dal Basale fino alla fine dello studio (Settimana 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
    Tollerabilità e Immunogenicità
    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 concerned2
    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 Information not present in EudraCT
    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 years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days24
    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 state4
    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 Decision2021-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-13
    P. End of Trial
    P.End of Trial StatusOngoing
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