Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-004335-24
    Sponsor's Protocol Code Number:CC-93538-EE-002
    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:2021-10-29
    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 number2020-004335-24
    A.3Full title of the trial
    A Phase 3, Multicenter, Multinational, Open-Label Extension Study to evaluate the Long-Term Safety of CC-93538 in adult and adolescent subjects with Eosinophilic Esophagitis
    Studio di estensione in Aperto di Fase 3, Multicentrico, Multinazionale per valutare la sicurezza a lungo termine di CC-93538 in soggetti adulti e adolescenti affetti da Esofagite Eosinofila
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis
    Studio per valutare la sicurezza a lungo termine di CC-93538 in pazienti adulti e adolescenti affetti da esofagite eosinofila
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberCC-93538-EE-002
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1259-1126
    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 SponsorCELGENE INTERNATIONAL II SàRL
    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 supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGSM-CT
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance-Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.4Telephone number000000
    B.5.5Fax number000000
    B.5.6E-mailclinical.trials@bms.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.2.1.1.1Trade name Cendakimab
    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 nameCendakimab
    D.3.2Product code [CC-93538]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNCendakimab
    D.3.9.2Current sponsor codeCC-93538
    D.3.9.4EV Substance CodeCC-93538
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    EOSINOPHILIC ESOPHAGITIS
    ESOFAGITE EOSINOFILA
    E.1.1.1Medical condition in easily understood language
    Eosinophilic esophagitis (EoE) is a chronic disease that affects food intake and quality of life.
    L’esofagite eosinofila (Eosinophilic esophagitis, [EoE]) è una malattia cronica che influisce sull’assunzione di cibo e sulla qualità della vita.
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10064220
    E.1.2Term Eosinophilic esophagitis
    E.1.2System Organ Class 100000004856
    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 long-term safety and tolerability of CC-93538 in subjects with eosinophilic esophagitis (EoE).
    Valutare la sicurezza e la tollerabilità a lungo termine di CC-93538 in soggetti affetti da esofagite eosinofila (EoE).
    E.2.2Secondary objectives of the trial
    To characterize the immunogenicity profile of CC-93538 following longterm treatment.
    Caratterizzare il profilo di immunogenicità di CC-93538 in seguito al trattamento a lungo termine
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Endolumenal Functional Lumen Imaging Probe (EndoFLIP TM) Substudy
    Objective: An optional sub-study will be performed at a subset of clinical sites utilizing an Endolumenal Functional Lumen Imaging Probe (EndoFLIP) to evaluate the effects of CC-93538 on esophageal distensibility.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio sulla sonda endoluminale EndoFLIP (Functional Lumen Imaging Probe) TM
    Obiettivo: Un sottostudio facoltativo sarà condotto presso un sottogruppo di centri clinici utilizzando una sonda endoluminale EndoFLIP (Functional Lumen Imaging Probe) per valutare gli effetti di CC-93538 sulla distensibilità esofagea.
    E.3Principal inclusion criteria
    • Previously participated in prior clinical study CC-93538-EE-001 and either:
    - completed both the Induction and Maintenance phases; or
    - completed the Induction Phase, however, did not qualify for the
    Maintenance Phase, including having a severe EoE flare requiring endoscopic intervention or rescue therapy.
    • Demonstrated compliance with required investigational product dosing during the prior study.
    • Did not permanently discontinue investigational product in the prior study and/or did not experience any clinically significant adverse events related to Investigational Product that would preclude further dosing.
    • Females of childbearing potential must have a negative pregnancy test prior to the first dose of open-label CC-93538 and agree to practice a highly effective method of contraception (as defined in the prior study) until 5 months after the last dose of open-label CC-93538.
    • Pregressa partecipazione al precedente studio clinico CC-93538-EE-001 e:
    - completamento sia della fase di induzione che di mantenimento; oppure
    - completamento della fase di induzione, senza però risultare idoneo alla fase di mantenimento, inclusa la presenza di una riacutizzazione grave dell’EoE che ha richiesto un intervento endoscopico o una terapia di soccorso.
    • Conformità dimostrata alla somministrazione del prodotto sperimentale richiesta durante lo studio precedente.
    • Nessuna interruzione permanente del prodotto sperimentale nel precedente studio e/o nessuna manifestazione di qualsiasi evento avverso clinicamente significativo correlato al prodotto sperimentale che precluderebbe un’ulteriore somministrazione.
    • Le donne in età fertile devono presentare un test di gravidanza negativo prima di ricevere la prima dose di CC-93538 in aperto e accettare di adottare un metodo contraccettivo altamente efficace (come definito nel precedente studio) fino a 5 mesi dopo l’ultima dose di CC-93538 in aperto.
    E.4Principal exclusion criteria
    • Clinical or endoscopic evidence of other diseases or conditions that may affect or confound the histologic, endoscopic, or clinical symptom evaluation for this study.
    • Active Helicobacter pylori infection or esophageal varices.
    • Evidence of immunosuppression, or of having received systemic immunosuppressive or immunomodulating drugs within 5 drug half-lives prior to open-label extension study (OLE) Day 1. Use of these agents is prohibited during the study.
    • Treatment with oral or sublingual immunotherapy within 6 months of OLE Day 1. Use of these agents is prohibited during the study.
    • Received an investigational product, other than that administered in CC-93538-EE-001, within 5 half-lives prior to OLE Day 1 (includes investigational product received during an interventional trial for COVID19). Those vaccinated with an investigational COVID-19 vaccine during CC-93538-EE-001 are not eligible, unless allowed following a discussion with the Clinical Trial Physician.
    • Received a live attenuated vaccine within one month prior to OLE Day 1; or anticipates the need for a live attenuated vaccine at any time throughout the course of this study.
    • Any disease that would affect the conduct of the protocol or interpretation of the study results, or would put a patient at risk by participating in the study (e.g. colitis, celiac disease, Mendelian disorder associated with EoE, severe uncontrolled asthma, infection causing eosinophilia, hypereosinophilic syndrome, or cardiovascular condition, or neurologic or psychiatric illness that could compromise the subject's ability to accurately document symptoms of EoE; newly diagnosed malignancy, lymphoproliferative disease, or clinically significant laboratory abnormality).
    • Active or ongoing infections including parasitic/helminthic infections, viral hepatitis, tuberculosis, or HIV.
    • Has had idiopathic anaphylaxis or major immunologic reaction to an immunoglobulin-G containing agent; or any known hypersensitivity to any ingredient in CC-93538.
    • Females who are pregnant or lactating
    • Evidenza clinica o endoscopica di altre malattie o condizioni che possono influenzare o confondere la valutazione dei sintomi istologici, endoscopici o clinici per questo studio.
    • Infezione da Helicobacter pylori attiva o varici esofagee.
    • Evidenza di immunosoppressione o di trattamento con farmaci immunosoppressori sistemici o immunomodulatori entro 5 emivite del farmaco precedentemente al Giorno 1 dello studio di estensione in aperto (Open Label Extension, [OLE]). L’uso di questi agenti è proibito durante lo studio.
    • Trattamento con immunoterapia per via orale o sublinguale entro 6 mesi dal Giorno OLE 1. L’uso di questi agenti è proibito durante lo studio.
    • Assunzione di un prodotto sperimentale, diverso da quello somministrato nello studio CC-93538-EE-001, entro 5 emivite precedenti il Giorno OLE 1 (include il prodotto sperimentale ricevuto durante una sperimentazione interventistica per la COVID-19). I vaccinati con un vaccino sperimentale anti-COVID-19 durante CC-93538-EE-001 non sono idonei, a meno che non siano ammessi dopo una discussione con il medico della sperimentazione clinica.
    • Ricezione di un vaccino vivo attenuato entro un mese prima del Giorno OLE 1 o necessità prevista di ricevere un vaccino vivo attenuato in qualsiasi momento durante tutto il corso di questo studio.
    • Qualsiasi malattia che renderebbe difficile la conduzione del protocollo o l’interpretazione dei risultati dello studio o che metterebbe il paziente a rischio se partecipasse allo studio (per es., colite, celiachia, disturbo mendeliano associato all’EoE, asma grave non controllata, infezione che causa eosinofilia, sindrome ipereosinofila o malattia cardiovascolare, neurologica o psichiatrica che potrebbe compromettere la capacità del soggetto di documentare accuratamente i sintomi di EoE; neoplasia maligna di nuova diagnosi, malattia linfoproliferativa o anomalia di laboratorio clinicamente significativa).
    • Infezioni attive o in corso, comprese infezioni parassitarie/elmintiche, epatite virale, tubercolosi o infezione da virus dell’immunodeficienza umana (Human Immunodeficiency Virus, [HIV]).
    • Pregressa anafilassi idiopatica o reazione immunologica maggiore a un agente contenente immunoglobuline-G; o ipersensibilità nota a qualsiasi ingrediente di CC-93538.
    • Donne in stato di gravidanza o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability of long-term treatment with CC-93538 evaluated by the incidence, severity, and relationship to CC-93538 of adverse events (AEs), serious adverse events (SAEs), clinical laboratory abnormalities, changes in vital signs, and physical examination abnormalities.
    Sicurezza e tollerabilità del trattamento a lungo termine con CC-93538 valutate mediante l’incidenza, la gravità, e il legame con CC-93538 di eventi avversi (EA), eventi avversi gravi (Serious Adverse Events, [SAE]), anomalie cliniche di laboratorio, variazioni nei segni vitali e anomalie dell’esame obiettivo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline through Safety Follow-up Visit
    Dal basale alla visita di follow-up di sicurezza
    E.5.2Secondary end point(s)
    Immunogenicity of CC-93538 assessed through the incidence of antidrug antibodies, including neutralizing antibodies when warranted.
    Immunogenicità di CC-93538 valutata attraverso l’incidenza di anticorpi anti-farmaco, inclusi anticorpi neutralizzanti quando necessario.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline through Safety Follow-up Visit
    Dal basale alla visita di follow-up di sicurezza
    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 Yes
    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 No
    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 trial1
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA64
    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
    Canada
    Israel
    Japan
    United States
    Austria
    Belgium
    Germany
    Italy
    Poland
    Portugal
    Spain
    Switzerland
    United Kingdom
    Argentina
    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 Study is defined as either the date of the last visit of the last subject to complete the post-treatment follow-up, or the date of receipt of the last data point from the last subject that is required for primary, secondary, and/or exploratory analysis, as pre-specified in the protocol, whichever is the later date.
    La fine dello studio è definita come la data dell’ultima visita dell’ultimo soggetto a completamento del follow-up post-trattamento, o come la data di acquisizione degli ultimi dati dell’ultimo soggetto necessari per l’analisi primaria, secondaria e/o esplorativa, a seconda di quale data sia posteriore, come prespecificato nel protocollo.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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: 19
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 239
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 52
    F.4.2.2In the whole clinical trial 259
    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)
    Where applicable per local or national regulations, subjects may continue in the study until marketing approval is obtained in the country or the Sponsor discontinues the study, whichever comes first.
    Ove applicabile in base alle normative locali o nazionali, i soggetti potranno continuare a partecipare allo studio fino all’ottenimento dell’approvazione all’immissione in commercio nel Paese o fino all’interruzione dello studio da parte dello Sponsor, a seconda di quale evento si verifichi prima.
    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 Decision2022-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-08
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 14:28:54 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA