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    Summary
    EudraCT Number:2020-000597-26
    Sponsor's Protocol Code Number:BO42161
    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:2021-06-22
    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 number2020-000597-26
    A.3Full title of the trial
    A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) CURRENTLY TREATED WITH COMPLEMENT INHIBITORS
    STUDIO DI FASE III, RANDOMIZZATO, IN APERTO, CON CONTROLLO ATTIVO, MULTICENTRICO, FINALIZZATO A VALUTARE L’EFFICACIA E LA SICUREZZA DI CROVALIMAB RISPETTO A ECULIZUMAB IN PAZIENTI ADULTI E ADOLESCENTI CON EMOGLOBINURIA PAROSSISTICA NOTTURNA (EPN) ATTUALMENTE TRATTATA CON INIBITORI DEL COMPLEMENTO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Crovalimab versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated with Complement Inhibitors.
    Studio finalizzato a valutare l’efficacia e la sicurezza di crovalimab rispetto a eculizumab in pazienti adulti e adolescenti con emoglobinuria parossistica notturna (EPN) attualmente trattati con inibitori del complemento.
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberBO42161
    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.Hoffman-La Roche Ltd
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportChugai Pharmaceutical Co. Ltd
    B.4.2CountryJapan
    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]
    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.3.9.2Current sponsor codeRO7112689
    D.3.9.4EV Substance CodeSUB197998
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Eculizumab
    D.2.1.1.2Name of the Marketing Authorisation holderAlexion Pharmaceuticals, Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameeculizumab
    D.3.2Product code [na]
    D.3.4Pharmaceutical form Concentrate and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNeculizumab
    D.3.9.1CAS number 219685-50-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB25187
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH)
    EMOGLOBINURIA PAROSSISTICA NOTTURNA (EPN)
    E.1.1.1Medical condition in easily understood language
    PNH is a rare acquired disorder that lead to destruction of red blood cells, blood clots, and impaired bone marrow function.
    L’EPN è un raro disturbo acquisito che comporta la distruzione dei globuli rossi, la formazione di coaguli di sangue e compromette la funzionalità del midollo osseo.
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10034042
    E.1.2Term Paroxysmal nocturnal haemoglobinuria
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of crovalimab compared to eculizumab
    Valutare l’efficacia di crovalimab rispetto a eculizumab
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of crovalimab compared with eculizumab based on the non-inferiority assessment
    • To evaluate the safety and tolerability of crovalimab compared to eculizumab
    • To characterize the crovalimab, eculizumab, and ravulizumab pharmacokinetics profile
    • To evaluate the immune response to crovalimab
    • To identify and/or evaluate biomarkers that can potentially provide evidence of crovalimab, eculizumab, and ravulizumab activity

    •Valutare l’efficacia di crovalimab rispetto a eculizumab in base alla valutazione della non inferiorità
    •Valutare la sicurezza e la tollerabilità di crovalimab rispetto a eculizumab
    •Caratterizzare il profilo farmacocinetico di crovalimab, eculizumab e ravulizumab • Valutare la risposta immunitaria a crovalimab
    •Identificare e/o valutare i biomarcatori che possono potenzialmente fornire evidenza dell’attività di crovalimab, eculizumab e ravulizumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Inclusion Criteria (All Patients)
    - Body weight >= 40 kg
    - Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry evaluation of WBCs,
    - Vaccination against Neisseria meningitidis < 3 years prior to initiation of study treatment, in accordance with most current local guidelines or standard-of-care as applicable in patients with complement deficiency
    - For women of childbearing potential: agreement to remain abstinent or use contraception
    For Patients in Randomized Arms (Arm A and B)
    - Age >= 18 years
    - Documented treatment with eculizumab according to the approved dosing recommended for PNH and completion of a minimum of 24 weeks of treatment prior to Day 1
    - Lactate dehydrogenase (LDH) <= 1.5 × ULN at screening
    For Patients in Descriptive Arm (Arm C)
    - Age 12-18 old, currently treated with eculizumab OR
    - Age >= 12 years old currently treated with ravulizumab OR
    - Age >= 12 years old currently treated with eculizumab at higher-than-approved doses OR
    - Patients with known C5 polymorphism and poorly controlled hemolysis by eculizumab or ravulizumab


    Criteri di inclusione generali (tutti i pazienti)
    - Peso corporeo >=40 kg
    - Diagnosi documentata di EPN, confermata dalla valutazione citometrica a flusso ad alta sensibilità dei globuli bianchi (WBC)
    - Vaccinazione contro Neisseria meningitidis eseguita <3 anni prima dell’inizio del trattamento dello studio, in conformità con le più recenti linee guida locali o standard di cura, a seconda dei casi, nei pazienti con deficit del complemento
    - Per le donne in età fertile: accordo a praticare l’astinenza o all’utilizzo di un metodo contraccettivo
    Per i pazienti randomizzati nei bracci (Braccio A e B)
    - Età >=18 anni
    - Trattamento documentato con eculizumab secondo il dosaggio approvato raccomandato per l’EPN e completamento di almeno 24 settimane di trattamento prima del Giorno 1
    - Lattato deidrogenasi (LDH) <=1,5 volte il limite superiore della norma (ULN) allo screening
    Per i pazienti nel braccio descrittivo (Braccio C)
    - Età 12-18 anni, attualmente trattati con eculizumab, O
    - Età >= 12 anni attualmente trattati con ravulizumab, O
    - Età >=12 anni attualmente trattati con eculizumab a dosi superiori a quella approvata, O
    - Pazienti con noto polimorfismo di C5 ed emolisi scarsamente controllata da eculizumab o ravulizumab
    E.4Principal exclusion criteria
    - Major Adverse Vascular Event within 6 months prior to first drug administration (Day 1)
    - Platelet count < 30000/mm3 at screening
    - ANC < 500/microlitre at screening
    - History of allogeneic bone marrow transplantation,
    - Neisseria meningitidis infection within 6 months prior to screening and up to first study drug administration
    - Pregnant or breastfeeding, or intending to become pregnant during the study or within 6 months after the final dose of study treatment
    - 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
    - Splenectomy <= 6 months prior to screening
    - Positive for hepatitis B surface antigen at screening
    - Positive for hepatitis C virus antibody at screening confirmed by detectable HCV RNA
    - History of or ongoing cryoglobulinemia at screening
    - Importante evento avverso vascolare nei 6 mesi precedenti la prima somministrazione del farmaco (Giorno 1)
    - Conta piastrinica <30.000/mm3 allo screening
    - Conta assoluta dei neutrofili (ANC) <500/microlitro allo screening
    - Anamnesi di trapianto allogenico di midollo osseo
    - Infezione da Neisseria meningitidis nei 6 mesi precedenti lo screening e fino alla prima somministrazione del farmaco dello studio
    - Donne in stato di gravidanza o allattamento, o che intendono avviare una gravidanza durante lo studio o entro 6 mesi dopo la dose finale del trattamento dello studio
    - Concomitanza di malattia, trattamento, procedura, intervento chirurgico o anomalia nelle analisi cliniche di laboratorio che potrebbe interferire con la conduzione dello studio, potrebbe comportare un rischio aggiuntivo per il paziente o che, a giudizio dello sperimentatore, potrebbe precludere la partecipazione sicura del paziente e il completamento dello studio
    - Splenectomia eseguita =6 mesi prima dello screening
    - Positività all’antigene di superficie del virus dell’epatite B allo screening
    - Positività agli anticorpi anti-virus dell’epatite C allo screening confermata dall’RNA di HCV rilevabile
    - Anamnesi o presenza di crioglobulinemia allo screening
    E.5 End points
    E.5.1Primary end point(s)
    Mean percent change in LDH level
    Variazione percentuale media del livello di LDH
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Baseline to Week 25
    Dal basale alla Settimana 25
    E.5.2Secondary end point(s)
    1. Proportion of patients with transfusion avoidance
    2. Proportion of patients with breakthrough hemolysis
    3. Proportion of patients with stabilization of hemoglobin
    4. Mean change in fatigue as assessed through use of the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale
    5. Incidence and severity of adverse events
    6. Change from baseline in targeted vital signs
    7. Change from baseline in targeted clinical laboratory test results
    8. Incidence and severity of injection-site reactions, infusion-related reactions, hypersensitivity, and infections
    9. Incidence of adverse events leading to study drug discontinuation
    10. Incidence and severity of clinical manifestations of drug-target-drug complex formation in patients who switched to crovalimab treatment from eculizumab or ravulizumab treatment
    11. Serum concentration of crovalimab or eculizumab
    12. Serum concentration of ravulizumab
    13. Prevalence and incidence of anti-drug antibodies (ADAs) to crovalimab
    14. Change over time in pharmacodynamic biomarkers
    15. Change over time in free C5 concentration in crovalimab-treated patients
    16. Observed value and absolute change in parameters reflecting hemolysis

    1. Percentuale di pazienti che evitano trasfusioni
    2. Percentuale di pazienti con emolisi episodica
    3. Percentuale di pazienti con stabilizzazione dell’emoglobina
    4. Variazione media nello stato di affaticamento, valutata mediante l’uso della scala funzionale di valutazione della terapia per malattia cronica (FACIT)-Affaticamento
    5. Incidenza e gravità degli eventi avversi
    6. Variazione rispetto al basale nei segni vitali mirati
    7. Variazione rispetto al basale nei risultati delle analisi cliniche di laboratorio mirate
    8. Incidenza e gravità delle reazioni nel sito di iniezione, reazioni correlate all’infusione, ipersensibilità e infezioni
    9. Incidenza degli eventi avversi che hanno portato all’interruzione del farmaco dello studio
    10. Incidenza e gravità delle manifestazioni cliniche correlate alla formazione di complessi farmaco-bersaglio del farmaco in pazienti che sono passati dal trattamento con eculizumab o ravulizumab al trattamento con crovalimab
    11. Concentrazione sierica di crovalimab o eculizumab
    12. Concentrazione sierica di ravulizumab
    13. Prevalenza e incidenza di anticorpi anti-farmaco (ADA) diretti contro crovalimab
    14. Variazione nel tempo nei biomarcatori farmacodinamici
    15. Variazione nel tempo della concentrazione di C5 libero in pazienti trattati con crovalimab
    16. Valore osservato e variazione assoluta nei parametri indicativi di emolisi
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4. From Baseline to Week 25
    5. Up to 2.5 years
    6-7. From baseline to 2.5 years
    8-9. Up to 2.5 years
    10. From baseline to 2.5 years
    11. Up to 2.5 years (crovalimab) and up to Week 25 (eculizumab)
    12. At baseline
    13. At baseline (prevalence) and up to 2.5 years (incidence)
    14-16 Up to 2.5 years

    1-4. Dal basale alla Settimana 25
    5. Fino a 2,5 anni
    6-7. Dal basale a 2,5 anni
    8-9. Fino a 2,5 anni
    10. Dal basale a 2,5 anni
    11. Fino a 2,5 anni (crovalimab) e fino alla Settimana 25 (eculizumab)
    12. Al basale
    13. Al basale (prevalenza) e fino a 2,5 anni (incidenza)
    14-16 Fino a 2,5 anni
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Evaluation of the immune response to Crovalimab.
    Identification and evaluation of biomarkers that can potentially provide evidence of crovalimab, eculizumab and ravulizumab activity.
    Valutazione della risposta immunitaria a crovalimab. Identificazione e/o valutazione di biomarcatori che possono potenzialmente fornire evidenza dell’attività di crovalimab, eculizumab e ravulizumab
    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 Yes
    E.8.1.1Randomised Yes
    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) Yes
    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 concerned6
    E.8.5The trial involves multiple Member States No
    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
    Colombia
    Hong Kong
    Israel
    Japan
    Korea, Republic of
    Mexico
    Taiwan
    Thailand
    Turkey
    United States
    Belgium
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Portugal
    Spain
    Sweden
    United Kingdom
    Czechia
    Greece
    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
    The end of this study is defined as the date when the last remaining patient has completed the last visit (LPLV) as defined by any of the criteria outlined in section 3.2.1. of the protocol- For patients randomized or enrolled to crovalimab; For patients randomized to eculizumab; Discontinuation prior to completion of last treatment; Withdrawal of consent; Loss to follow-up.
    La conclusione di questo studio corrisponde alla data in cui l’ultimo paziente restante ha completato l’ultima visita (LPLV), secondo quanto definito da uno dei criteri descritti nella sezione 3.2.1. del protocollo. Per i pazienti randomizzati o arruolati a crovalimab; Per i pazienti randomizzati a eculizumab; Ritiro prima del completamento dell’ultimo trattamento; Ritiro del consenso; Perdita al follow-up.
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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 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: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 195
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 250
    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 continued access to Roche IMP (crovalimab) free of charge to eligible patients in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, as outlined in section 4.3.5 of the protocol.
    Lo sponsor offrirà un accesso continuo e gratuito al medicinale sperimentale (IMP) di Roche ai pazienti idonei in conformità con la politica globale di Roche sull’accesso continuo al prodotto medicinale sperimentale, come descritto nella Sezione 4.3.5 del protocollo.
    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 Decision2020-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-10
    P. End of Trial
    P.End of Trial StatusOngoing
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