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    Summary
    EudraCT Number:2020-004335-24
    Sponsor's Protocol Code Number:CC-93538-EE-002
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-11-18
    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 ConcernedAustria - BASG
    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
    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
    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.5.6E-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.2.5The 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 CodeSUB201796
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    E.1.1.1Medical condition in easily understood language
    Eosinophilic esophagitis (EoE) is a chronic disease that affects food intake and quality of life.
    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 10017947 - Gastrointestinal 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 long-term safety and tolerability of CC-93538 in subjects with eosinophilic esophagitis (EoE).
    E.2.2Secondary objectives of the trial
    To characterize the immunogenicity profile of CC-93538 following long-term treatment.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Endolumenal Functional Lumen Imaging Probe (EndoFLIP TM) Sub-study
    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.
    E.3Principal inclusion criteria
    1 a. Subject must have participated in Study CC-93538-EE-001, and
    meets one of the following criteria:
    1) Subject experienced a severe EoE flare requiring endoscopic
    intervention and/or concomitant rescue therapy during the Induction
    Phase and has completed Week 24 of the Induction Phase; OR
    2) Subject completed the Induction Phase and does not qualify for
    entry to the Maintenance Phase for reasons other than a severe EoE
    flare; OR
    3) Subject experienced a severe EoE flare requiring endoscopic
    intervention and/or concomitant rescue therapy during the Maintenance
    Phase and completed Week 48 of the Maintenance Phase; OR
    4) Subject completed Week 48 of the Maintenance Phase
    b. OR Subject must have participated in Study CC-93538-DDI-001 and
    completed assessments in Period 2 through Week 18/End of Treatment
    Visit
    2. Demonstrated compliance with required investigational product
    dosing during the prior Study CC-93538-EE-001 or Study CC-93538-DDI-001 and subject must not have been permanently discontinued from IP
    while participating in Study CC-93538-EE-001 or Study CC-93538-DDI-001.
    3. Subjects must have not experienced any clinically significant adverse
    events related to Investigational Product that would preclude further
    dosing.
    4. 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.
    5. Subject (18 years of age or older) must understand and voluntarily
    sign an informed consent form (ICF) prior to any study-related
    assessments/procedures being conducted. For subjects less than 18
    years of age, subject assent must be obtained, and parental/legal
    representative consent is required. Adolescent subjects who reach the
    legal age of consent while participating in the study will be asked to sign
    an ICF (called a Transitional ICF) themselves to acknowledge their
    willingness to continue in the study. In Austria, Germany, Spain, and
    Switzerland, adolescent subjects will not be enrolled.
    E.4Principal exclusion criteria
    1. Clinical or endoscopic evidence of other diseases or conditions that
    may affect or confound the histologic, endoscopic, or clinical symptom
    evaluation for this study.
    2. Subject demonstrates presence of esophageal varices.
    3. Subject has a known active Helicobacter pylori infection and/or is
    currently being treated for this condition
    4. 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.
    5. Treatment with oral or sublingual immunotherapy within 6 months of
    OLE Day 1. Use of these agents is prohibited during the study.
    6. Received an investigational product, other than that administered in
    CC-93538-EE-001 or Study CC-93538-DDI-001, within 5 half-lives prior
    to OLE Day 1 (includes investigational product received during an
    interventional trial for COVID-19). Those vaccinated with an
    investigational COVID-19 vaccine during CC-93538-EE-001 or Study CC-93538-DDI-001 are not eligible, unless allowed following a discussion
    with the Clinical Trial Physician.
    7. 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.
    8. 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, a documented medical
    diagnosis of gastritis, which is clinically significant in the judgment of
    the Investigator; colitis, celiac disease, Mendelian disorder associated
    with EoE, or cardiovascular condition, or neurologic or psychiatric illness
    that compromises the prospective subject's ability to accurately
    document symptoms of EoE).
    9. Active or ongoing infections including parasitic/helminthic infections
    10. Subject has a chronic infection (eg, hepatitis B or C, human
    immunodeficiency virus [HIV], or tuberculosis as defined by standard
    medical guidelines).
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline through Safety Follow-up Visit
    E.5.2Secondary end point(s)
    Immunogenicity of CC-93538 assessed through the incidence of anti-drug antibodies, including neutralizing antibodies when warranted.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline through Safety Follow-up Visit
    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 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) 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 concerned4
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Switzerland
    Australia
    Canada
    Israel
    Japan
    United Kingdom
    United States
    Austria
    Belgium
    Germany
    Italy
    Poland
    Portugal
    Spain
    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.
    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 months4
    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.1.1Number of subjects for this age range: 19
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 57
    F.4.2.2In the whole clinical trial 269
    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.
    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 Decision2022-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-19
    P. End of Trial
    P.End of Trial StatusOngoing
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