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    Summary
    EudraCT Number:2020-002475-35
    Sponsor's Protocol Code Number:BO42353
    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:2021-06-07
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-002475-35
    A.3Full title of the trial
    A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS)
    STUDIO DI FASE III MULTICENTRICO, A BRACCIO SINGOLO, PER VALUTARE L’EFFICACIA, LA SICUREZZA, LA FARMACOCINETICA E LA FARMACODINAMICA DI CROVALIMAB IN PAZIENTI ADULTI E ADOLESCENTI CON SINDROME EMOLITICO UREMICA ATIPICA (SEUa)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Evaluating the Efficacy and Safety of Crovalimab in Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)
    Uno studio per valutare l’efficacia, la sicurezza di crovalimab in pazienti adulti e adolescenti con sindrome emolitico-uremica atipica (SEUa)
    A.3.2Name or abbreviated title of the trial where available
    COMMUTE-a
    COMMUTE-a
    A.4.1Sponsor's protocol code numberBO42353
    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 SponsorF. HOFFMANN - LA ROCHE LTD.
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 namecrovalimab
    D.3.2Product code [RO7112689/F03-10]
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcrovalimab
    D.3.9.1CAS number 1917321-26-6
    D.3.9.2Current sponsor codeRO7112689
    D.3.9.3Other descriptive nameC5 inh MAb, SKY59, RO/CH7092230
    D.3.9.4EV Substance CodeSUB183839
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number170
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Atypical Hemolytic Uremic Syndrome (aHUS)
    Sindrome emolitico uremica atipica (SEUa)
    E.1.1.1Medical condition in easily understood language
    aHUS is a rare disease, characterized by damage to the lining of small blood vessels, leading to red blood cell destruction, blood clots and kidney damage.
    aHUS è una malattia rara, caratterizzata da danni al rivestimento di piccole dimensioni vasi sanguigni, con conseguente distruzione dei globuli rossi, coaguli di sangue e
    danno ai reni.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10079841
    E.1.2Term Atypical hemolytic uremic syndrome
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To evaluate the effect of crovalimab in complement inhibitor treatment-naive (Naive) patients
    L’obiettivo di efficacia primario di questo studio è valutare l’effetto del trattamento con crovalimab in pazienti naïve al trattamento
    E.2.2Secondary objectives of the trial
    •To evaluate the effect of crovalimab in patients in the Naïve and Switch (switching from an existing complement inhibitor treatment to crovalimab) patients
    •To evaluate the overall safety and tolerability of crovalimab
    •To evaluate the pharmacokinetics of crovalimab
    •To evaluate the immune response to crovalimab
    • Valutare l'effetto di crovalimab in pazienti Naïve e Switch (passaggio da un trattamento esistente con inibitori del complemento a crovalimab)
    • Valutare la sicurezza e la tollerabilità complessive di crovalimab
    • Valutare la farmacocinetica di crovalimab
    • Valutare la risposta immunitaria al crovalimab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For all Cohorts (all patients, in the Naïve, Switch and C5 SNP Cohorts, must meet the following criteria for study entry):
    • Age >= 12 years
    • Body weight >= 40 kg at screening
    • Vaccination against Neisseria meningitidis < 3 years prior to initiation of study treatment in accordance with current local guidelines or standard of care, as applicable in patients with complement deficiency
    • For female patients of childbearing potential, an agreement to remain abstinent or use contraception
    • Patients with a prior kidney transplant are eligible if they have known history of complement-mediated aHUS prior to the kidney transplant
    For Naive Cohort ONLY:
    • Evidence of thrombotic microangiopathy (TMA)
    • Onset of TMA 28 days prior to first crovalimab administration
    For Switch Cohort ONLY:
    • Documented treatment with eculizumab or ravulizumab according to the local product label for aHUSEculizumab treatment received for at least 90 days. Patients switching from IV ravulizumab must have received at least two maintenance doses
    • Clinical evidence of response to either eculizumab or ravulizumab
    For C5 SNP Cohort only:
    • Known C5 polymorphism (e.g., Arg885)
    • Documented treatment with eculizumab or ravulizumab for aHUS, with poorly controlled TMA, per investigator's assessment


    • Firma del modulo di assenso, se appropriato in base all’età del paziente e agli specifici standard del centro e del Paese
    • Età >= 12 anni al momento della firma del modulo di consenso informato o del modulo di assenso
    • Peso corporeo >= 40 kg allo screening
    • Volontà e capacità di attenersi a tutte le visite e le procedure previste dallo studio
    • Vaccinazione contro Neisseria meningitidis < 3 anni prima dell’avvio del trattamento dello studio, oppure, se non eseguita in precedenza, somministrata non più tardi di una settimana dopo la prima somministrazione del farmaco in studio.
    • Vaccinazione contro Haemophilus influenzae di tipo B e Streptococcus pneumoniae ai sensi delle raccomandazioni nazionali relative a vaccinazioni e profilassi antibiotica
    • I pazienti che sono stati vaccinati (parzialmente o totalmente) contro SARS-CoV-2 con un vaccino approvato localmente possono essere arruolati nello studio, 3 giorni o più dopo l'inoculazione.
    • Per i pazienti che ricevono altre terapie (per es. immunosoppressori, corticosteroidi, inibitore del bersaglio della rapamicina nei mammiferi [mammalian Target Of Rapamycin Inhibitor, mTORi]; [ossia sirolimus, everolimus] o inibitori della calcineurina [ossia ciclosporina o tacrolimus]): dose stabile da >=28 giorni al momento dello screening e fino alla prima somministrazione del farmaco dello studio
    • Funzione epatica adeguata, ALT <=3x ULN al momento dello screening; assenza di segni clinici o evidenze di laboratorio/radiografiche note coerenti con cirrosi
    • Per le pazienti in età fertile: consenso a praticare l’astinenza sessuale (astenersi dai rapporti eterosessuali) oppure a utilizzare misure contraccettive
    o Le donne devono praticare l’astinenza o utilizzare metodi contraccettivi caratterizzati da un tasso di insuccesso < 1% l’anno durante il periodo di trattamento e per almeno 6 mesi dopo l’ultima dose di crovalimab
    • I pazienti sottoposti in precedenza a trapianto renale sono eleggibili se presentano:
    o Una storia nota di SEUa complemento-mediata prima del trapianto renale
    Solo per la Coorte Naïve:
    • Evidenza di MT, attestata dalla presenza di tutti i seguenti risultati di laboratorio allo screening e fino alla prima somministrazione del farmaco
    Solo per la Coorte Switch:
    • Trattamento documentato con eculizumab o ravulizumab, in accordo al foglio illustrativo del farmaco in vigore localmente per la SEUa. Terapia con eculizumab in atto da almeno 90 giorni il Giorno 1 del trattamento dello studio. I pazienti che provengono dalla terapia con ravulizumab e.v. devono aver ricevuto almeno due dosi di mantenimento il Giorno 1 del trattamento dello studio.
    • Evidenza clinica di risposta a eculizumab o ravulizumab
    Solo per la coorte C5 SNP:
    • Polimorfismo C5 noto (ad es. Arg885)
    • Trattamento documentato con eculizumab o ravulizumab per SEUa, con MT scarsamente controllata, secondo la valutazione dello sperimentatore
    E.4Principal exclusion criteria
    For all Cohorts (all patients, in the Naïve, Switch and C5 SNP Cohorts, must meet the following criteria for study entry):
    • Diagnosis of TTP, Shiga toxin-producing Escherichia coli (STEC) hemolytic uremic syndrome (HUS), Pneumococcal HUS,
    • TMA secondary to cobalamin C defect
    • TMA related to diacylglycerol kinase (DGKE) nephropathy
    • TMA associated with non-aHUS related renal disease
    • Positive direct Coombs test
    • Identified drug exposure-related TMA
    • History of organ transplant, other than kidney transplant
    • Chronic dialysis, and/or end stage renal disease
    • History of a kidney disease, other than aHUS, affecting renal function
    • History of Neisseria meningitidis infection within 6 months prior to screening and up to the first drug administration
    • Known systemic sclerosis, systemic lupus erythematosus, or anti-phospholipid antibody positivity or syndrome
    • Patients receiving chronic IV immunoglobulin (IVIg) within 8 weeks prior to start of screening, unless for unrelated medical condition
    • Female patients who are pregnant, breastfeeding, or have the intention of becoming pregnant during the study or within 6 months after the final dose of the study treatment
    • Splenectomy < 6 months prior to screening
    • Use of tranexamic acid within 7 days prior to screening
    • Concurrent disease, treatment, procedure or surgery, or abnormality in clinical laboratory tests that could interfere with the conduct of the study, may pose any additional risk for the patient, or would, in the opinion of the investigator, preclude the patient's safe participation in and completion of the study
    For Naive Cohort ONLY:
    • Current or previous treatment with a complement inhibitor
    • Received plasma exchange/plasma infusion for 28 days or longer prior to the start of screening for aHUS

    For Switch Cohort and C5 SNP Cohort ONLY (additional exclusion criteria for Switch patients and for patients with a C5 polymorphism):
    • Positive for hepatitis B surface antigen (HBsAg) at screening (does not apply to C5 SNP patients who received their last dose of eculizumab or ravulizumab more than 6 months ago)
    • Positive for hepatitis C virus (HCV) antibody at screening (does not apply to C5 SNP patients who received their last dose of eculizumab or ravulizumab more than 6 months ago). Patients who are seropositive for HCV but without detectable HCV RNA are eligible
    • History of or ongoing cryoglobulinemia at screening (does not apply to C5 SNP patients who received their last dose of eculizumab or ravulizumab more than 6 months ago)
    •MT associata a malattia renale non dipendente da SEUa•Test diretto di Coombs positivo•Identificazione di MT correlata all’esposizione a farmaco
    •Storia di trapianto d’organo diverso dal trapianto renale•Dialisi cronica e/o malattia renale allo stadio terminale•Storia di malattia renale diversa da SEUa, che compromette la funzione renale•Storia di infezione da Neisseria meningitidis nei 6 m precedenti lo screening e fino alla prima somministrazione del farmaco
    •Immunodeficienza nota o sospetta •Positività test HIV•Aspettativa di vita ¿ 4 sett•Infezione sistemica attiva di natura batterica, virale o fungina nei 14 g prec la prima somministrazione farmaco•Presenza di febbre nei 7 g prec la prima somministrazione del farmaco•Pz con disfunzione o insufficienza d’organo multisistemica, attiva o in evoluzione•Immunizzazione con vaccino vivo attenuato nel mese prec la prima somministr farmaco•Presenza nota di sclerosi sistemica, lupus eritematoso sistemico o positività/sindrome da anticorpi antifosfolipidi•Pz in terapia cronica con immunoglobulina e.v. nelle 8 sett prec l’avvio dello screening, se non per patologia non correlata •Anamnesi di neoplasia maligna nei 5 an prec screening e fino prima somministrazione farmaco•Anamnesi di reazioni di ipersensibilità, allergiche o anafilattiche a uno degli eccipienti contenuti in crovalimab, compresa ipersensibilità anticorpi monoclonali umani, umanizzati o murini•Pz in stato di gravidanza, allattamento o che pianificano una gravidanza durante lo studio o nei 6 m successivi all’ultima dose del trattamento dello studio•Le pz potenzialmente fertili devono avere un risultato negativo al test di gravidanza sul siero effettuato nei 7 g prec l’inizio del farmaco dello studio.•Partecipazione ad altro studio sperimentale interventistico con agente sperimentale o utilizzo di una qualsiasi terapia sperimentale nei 28 g prec lo screening oppure cinque emivite del prodotto sperimentale, considerando il periodo più lungo tra i due•Abuso di sostanze nei 12 m prec screening, secondo giudizio PI•Splenectomia ¿ 6 m prima screening•Utilizzo acido tranexamico nei 7 g prec screening•Concomitante malattia, trattamento, procedura o chirurgia, o anomalia parametri clinici laboratorio
    Solo per la coorte Naïve (criteri di esclusione supplementari per i pazienti naïve):
    •Diagnosi di porpora trombotica trombicitopenica, stabilita in base a una riduzione ¿ 10% dei livelli di ADAMTS13
    •Diagnosi di sindrome emolitico-uremica da Escherichia coli produttore di tossina Shiga, attestata da un risultato positivo del test per rilevare la tossina Shiga o da una coltura di batteri produttori di tossina Shiga•Diagnosi di SEU pneumococcica attestata da una radiografia toracica o una coltura positiva di Streptococcus pneumoniae
    •MT secondaria a difetto della cobalamina C attestato aumento livelli ematici omocisteina tot e acido metilmalonico e/o da mutazioni gene MMACHC
    •MT correlata a nefropatia da diacilglicerolo chinasi ¿ causata da mutazione in omozigosi o eterozigosi composta gene che codifica per DGKE,con perdita di funzione
    Solo per le coorti Switch e C5 SNP (criteri di esclusione supplementari per i pz Switch e per i pz con polimorfismo del C5):
    •Positività antigene superficie epatite B screening•Positività anticorpo virus epatite C screening•I pz sieropositivi HCV ma con HCV-RNA non rilevabile sono eleggibili•Crioglobulinemia in anamnesi o in atto allo screening•Diagnosi di PTT all’insorgenza della MT, stabilita in base a una riduzione dei livelli di ADAMTS13 ¿ 10%•Diagnosi di SEU-STEC all’insorgenza della MT, attestata da un risultato positivo del test per rilevare la tossina Shiga o da una coltura di batteri produttori di tossina Shiga•Diagnosi di SEU pneumococcica all’insorgenza della MT, attestata da una radiografia toracica o una coltura positiva di Streptococcus pneumoniael•MT secondaria a difetto della cobalamina C•MT correlata a nefropatia DGKE
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of patients with complete TMA response (cTMAr)
    1. Proporzione di pazienti con risposta completa alla MT (cTMAr)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From baseline to Week 25
    1. Dal basale alla settimana 25
    E.5.2Secondary end point(s)
    For BOTH Cohorts:
    1. Dialysis requirement status (yes/no) change
    2. Observed value and change from baseline in estimated glomerular filtration rate (eGFR)
    3. Proportion of patients with change from baseline in chronic kidney disease stage
    4. Observed value and change from baseline in hematologic parameters
    5. In adults (>= 18 years), change from baseline in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Questionnaire
    6. Incidence and severity of adverse events
    7. Change in targeted vital signs and clinical laboratory test results
    8. Incidence and severity of injection-site reactions, infusion-related reactions, hypersensitivity, malignant hypertension, and infections
    9. Incidence of adverse events leading to study drug discontinuation
    10. Serum concentrations of crovalimab
    11. Prevalence and incidence of anti-drug antibodies (ADAs) to crovalimab

    For Naive Cohort ONLY:
    12. Proportion of patients with platelet count >= LLN
    13. Proportion of patients with normalization of LDH
    14. Proportion of patients with >= 25% decrease in serum creatinine from baseline
    15. Time to cTMAr
    16. Duration of cTMAr
    17. Proportion of patients with cTMAr

    For Switch Cohort ONLY:
    18. Proportion of patients with maintained TMA control (mTMAc)
    19. Incidence and severity of clinical manifestations of drug-target-drug complexes in patients who switched to crovalimab treatment from either eculizumab or ravulizumab treatment
    20. Serum concentration of eculizumab or ravulizumab
    Per ENTRAMBE le coorti:
    1. Modifica dello stato dei requisiti di dialisi (sì / no)
    2. Valore osservato e variazione rispetto al basale della velocità di filtrazione glomerulare stimata (eGFR)
    3. Proporzione di pazienti con variazione rispetto al basale nello stadio di malattia renale cronica
    4. Valore osservato e variazione rispetto al basale dei parametri ematologici
    5. Negli adulti (> = 18 anni), variazione rispetto al basale della fatica misurata dal questionario sulla valutazione funzionale della malattia cronica terapia-fatica
    6. Incidenza e gravità degli eventi avversi
    7. Modifica dei segni vitali mirati e dei risultati dei test clinici di laboratorio
    8. Incidenza e gravità delle reazioni al sito di iniezione, reazioni correlate all'infusione, ipersensibilità, ipertensione maligna e infezioni
    9. Incidenza di eventi avversi che hanno portato alla sospensione del farmaco in studio
    10. Concentrazioni sieriche di crovalimab
    11. Prevalenza e incidenza di anticorpi anti-farmaco (ADA) contro crovalimab

    SOLO per la coorte ingenua:
    12. Proporzione di pazienti con conta piastrinica> = LLN
    13. Proporzione di pazienti con normalizzazione di LDH
    14. Percentuale di pazienti con diminuzione> = 25% della creatinina sierica rispetto al basale
    15. È ora di cTMAr
    16. Durata del marchio comunitario
    17. Proporzione di pazienti con cTMAr

    SOLO per Switch Cohort:
    18. Proporzione di pazienti con controllo TMA mantenuto (mTMAc)
    19. Incidenza e gravità delle manifestazioni cliniche dei complessi farmaco-bersaglio-farmaco nei pazienti che sono passati al trattamento con crovalimab da un trattamento con eculizumab o ravulizumab
    20. Concentrazione sierica di eculizumab o ravulizumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From baseline to Week 25
    2-10. Up to 5 years
    11. At baseline (prevalence) and up to 5 years (incidence)
    12-14. At Week 25
    15-16. Up to 5 years
    17. At Week 25
    18. Up to 5 years
    19. From baseline to Week 10
    20. Day 1
    1. Dal basale alla settimana 25
    2-10. Fino a 5 anni
    11. Al basale (prevalenza) e fino a 5 anni (incidenza)
    12-14. Alla settimana 25
    15-16. Fino a 5 anni
    17. Alla settimana 25
    18. Fino a 5 anni
    19. Dal basale alla settimana 10
    20. Giorno 1
    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 No
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    studio in aperto
    open study
    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.8.2.4Number of treatment arms in the trial3
    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 EEA28
    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
    Australia
    Brazil
    Canada
    China
    Israel
    Korea, Republic of
    Mexico
    Peru
    South Africa
    Turkey
    United States
    Belgium
    France
    Germany
    Hungary
    Italy
    Luxembourg
    Poland
    Spain
    United Kingdom
    Czechia
    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
    LPLV
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 31
    F.4.2.2In the whole clinical trial 90
    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)
    The Sponsor will offer post-trial access to the study drug (RO7112689) free of charge to eligible patients, i.e., patients who derive clinical benefit from RO7112689, in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product. Please see section 4.4.4 of the protocol for further information.
    Lo Sponsor offrirà l'accesso post-prova al farmaco in studio (RO7112689) gratuitamente ai pazienti idonei, ovvero i pazienti che traggono benefici clinici da RO7112689, in conformità con la Roche Global Policy on Continued Access to Investigational Medicinal Product. Vedere la sezione 4.4.4 del protocollo per ulteriori informazioni.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Covance
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-15
    P. End of Trial
    P.End of Trial StatusOngoing
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