Clinical trial • Phase IV • Haematology|Rare Disease
CRIZANLIZUMAB for Sickle cell disease
Phase IV trial of CRIZANLIZUMAB for Sickle cell disease. open-label. 59 participants.
Overview
- Trial Therapeutic Area
- Haematology|Rare Disease
- Trial Disease
- Sickle cell disease
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 29-02-2024
- First CTIS Authorization Date
- 05-04-2024
Trial design
open-label Phase IV trial in Belgium, France, Germany and others.
- Open Label
- Yes
- Target Sample Size
- 59
Eligibility
Recruits 59 paediatric patients.
- Pregnancy Exclusion
- Pregnant or nursing women
- Vulnerable Population
- Minors are included; consent and assent handling is specified. Inclusion criterion: "Written informed consent/assent, according to local guidelines, signed by the adult patients." Translations/specifications note that assent for patients aged <18 must be obtained according to local recommendations and that consent must be provided by parents/legal representatives for patients under 18. Child and adolescent assent forms and parent/legal guardian ICFs are included in the trial documents.
Inclusion criteria
- {"criterion_text":"- Written informed consent/assent, according to local guidelines, signed by the adult patients."}
- {"criterion_text":"- SCD patient currently enrolled and benefitting from a Novartis-sponsored study receiving crizanlizumab and has fulfilled all the requirements"}
- {"criterion_text":"- Patient has demonstrated compliance to the planned visit schedule in the parent study, and in the opinion of the investigator has shown willingness and ability to comply with future visit schedules"}
Exclusion criteria
- {"criterion_text":"- Patient had permanently discontinued from crizanlizumab study treatment in the parent study before the parent study completion"}
- {"criterion_text":"- Ongoing/unresolved treatment-related Grade 3 or higher AEs, and/or any ongoing AE requiring dose interruption"}
- {"criterion_text":"- Concurrent participation in any other investigational clinical trial other than the parent study or plan to participate in any other investigational clinical trial"}
- {"criterion_text":"- Women of childbearing potential who are unwilling to be on highly effective contraceptives during dosing and until 15 weeks after stopping treatment with crizanlizumab"}
- {"criterion_text":"- Pregnant or nursing women"}
Endpoints
Primary endpoints
- {"endpoint_text":"- N/A","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Frequency, severity and causality of treatment emergent adverse events","definition_or_measurement_approach":"Assessment of the frequency, severity and causality of treatment-emergent adverse events; protocol translations indicate this includes evaluation of adverse events, clinical examinations and monitoring of vaso-occlusive crises."}
Recruitment
- Planned Sample Size
- 59
- Recruitment Window Months
- 120
- Consent Approach
- Written informed consent/assent is required according to local guidelines. Adult patients sign consent; for participants under 18 assent must be obtained per local recommendations and consent must be provided by the parent/legal guardian. The dossier includes parent/legal guardian ICFs and child and adolescent assent forms and main adult ICFs in multiple language versions (examples in the document list include English, German, French, Spanish, Italian, Dutch).
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 22
Belgium
- Earliest CTIS Part Ii Submission Date
- 13-03-2024
- Latest Decision Or Authorization Date
- 22-04-2024
- Processing Time Days
- 40
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
- Department Name
- 1110:Oncology
- Principal Investigator Name
- Laurence Dedeken
- Principal Investigator Email
- laurence.dedeken@huderf.be
- Contact Person Name
- Laurence Dedeken
- Contact Person Email
- laurence.dedeken@huderf.be
- Site Name
- Centre Hospitalier Regional De La Citadelle
- Department Name
- 1113: Oncology
- Principal Investigator Name
- Marie Françoise Dresse
- Principal Investigator Email
- mf.dresse@chuliege.be
- Contact Person Name
- Marie Françoise Dresse
- Contact Person Email
- mf.dresse@chuliege.be
France
- Earliest CTIS Part Ii Submission Date
- 13-03-2024
- Latest Decision Or Authorization Date
- 22-04-2024
- Processing Time Days
- 40
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Hopital Necker Enfants Malades
- Department Name
- 1402: Département de Recherche Clinique
- Principal Investigator Name
- Slimane Allali
- Principal Investigator Email
- slimane.allali@aphp.fr
- Contact Person Name
- Slimane Allali
- Contact Person Email
- slimane.allali@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 13-03-2024
- Latest Decision Or Authorization Date
- 10-04-2024
- Processing Time Days
- 28
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- 1300:Zentrum für Kinder- und Jugendmedizin
- Principal Investigator Name
- Joachim Kunz
- Principal Investigator Email
- Joachim.Kunz@med.uni-heidelberg.de
- Contact Person Name
- Joachim Kunz
- Contact Person Email
- Joachim.Kunz@med.uni-heidelberg.de
Italy
- Earliest CTIS Part Ii Submission Date
- 13-03-2024
- Latest Decision Or Authorization Date
- 20-05-2024
- Processing Time Days
- 68
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Azienda Ospedaliera Universitaria Integrata Verona
- Department Name
- 1500:Medicina Interna B Ospedale Borgo Roma
- Principal Investigator Name
- Lucia De Franceschi
- Principal Investigator Email
- lucia.defranceschi@univr.it
- Contact Person Name
- Lucia De Franceschi
- Contact Person Email
- lucia.defranceschi@univr.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- 1502:S.S.D. Microcitemie Pediatria
- Principal Investigator Name
- Giovanni Battista Ferrero
- Principal Investigator Email
- giovannibattista.ferrero@unito.it
- Contact Person Name
- Giovanni Battista Ferrero
- Contact Person Email
- giovannibattista.ferrero@unito.it
- Site Name
- Azienda Ospedale-Universita Padova
- Department Name
- 1501:U.O.C. Oncoematologia Pediatrica Università degli Studi
- Principal Investigator Name
- Raffaella Colombatti
- Principal Investigator Email
- raffaella.colombatti@unipd.it
- Contact Person Name
- Raffaella Colombatti
- Contact Person Email
- raffaella.colombatti@unipd.it
Spain
- Earliest CTIS Part Ii Submission Date
- 13-03-2024
- Latest Decision Or Authorization Date
- 05-04-2024
- Processing Time Days
- 23
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- 1200:Servicio de Oncohematología Infantil
- Principal Investigator Name
- Elena Cela de Julian
- Principal Investigator Email
- elena.cela@salud.madrid.org
- Contact Person Name
- Elena Cela de Julian
- Contact Person Email
- elena.cela@salud.madrid.org
- Site Name
- Vall D Hebron Institute Of Oncology
- Department Name
- 1201:Servicio de Oncología y Hematología Pediátrica
- Principal Investigator Name
- Cristina Díaz de Heredia
- Principal Investigator Email
- crdiaz@vhebron.net
- Contact Person Name
- Cristina Díaz de Heredia
- Contact Person Email
- crdiaz@vhebron.net
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- code:1
- Name
- IQVIA RDS Spain S.L.
- Responsibilities
- code:1
- Name
- Parexel International (IRL) Limited
- Responsibilities
- code:12
- Name
- IQVIA Limited
- Responsibilities
- code:3
- Name
- Syneos Health Clinical Spain S.L.
- Responsibilities
- code:1
- Name
- Fisher Clinical Services GmbH
- Responsibilities
- EU Hub distribution contact for clinical supplies shipment
- Name
- Rps Research Iberica S.L.
- Responsibilities
- code:1
Third parties
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"Movianto Belgium","duties_or_roles":"local storage of equipment (PETG containers for IMP preparation), destruction of IMP","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"IQVIA RDS Spain S.L.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code:12","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"TMF archive, Activation sites activities","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Syneos Health Clinical Spain S.L.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"EU Hub distribution contact for clinical supplies shipment","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Phardis S.r.l.","duties_or_roles":"Local equipment storage","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Rps Research Iberica S.L.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- SEG101
- Active Substance
- CRIZANLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Authorised
- Maximum Dose
- 7.5 mg/Kg
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