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   43861   clinical trials with a EudraCT protocol, of which   7284   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:2009-015508-24
    Sponsor's Protocol Code Number:CAIN457C2301E1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-01-15
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2009-015508-24
    A.3Full title of the trial
    A 38-week extension to a 24-week multicenter, randomized, double-masked, placebo controlled, dose-ranging phase III study of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression in patients with quiescent, non-infectious intermediate, posterior or panuveitis (ENDURE Study)
    A.3.2Name or abbreviated title of the trial where available
    ENDURE, C2301E1
    A.4.1Sponsor's protocol code numberCAIN457C2301E1
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbernot available
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma Services AG
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameAIN457
    D.3.2Product code AIN457
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant human monoclonal antibody to Interleukin-17A of the IgG1/kappa class
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adjunctive therapy to standard-of-care for the treatment of patients with quiescent, non-infectious intermediate, posterior or panuveitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10022941
    E.1.2Term Iridocyclitis
    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 continuous treatment with subcutaneous AIN457 compared to placebo for maintaining quiescence of intraocular inflammation and the prevention of active intermediate, posterior or panuveitis recurrences in adults with quiescent, non-infectious, uveitis affecting the posterior segment.
    E.2.2Secondary objectives of the trial
    Key secondary
    • To determine if continuous treatment with subcutaneous AIN457 can reduce/eliminate the need for concomitant standard-of-care immunosuppressive medications in patients requiring systemic immunosuppression to control their ocular inflammatory disease
    Secondary
    • To assess the safety of continuous targeted IL-17 inhibition with AIN457 in patients with quiescent, noninfectious, uveitis affecting the posterior segment receiving treatment over the course of 1 year
    • To determine the effect of continuous treatment with subcutaneous AIN457 on visual acuity, vitreous haze, anterior chamber cells and quality of life in patients with quiescent, noninfectious, uveitis affecting the posterior segment
    • To explore the relative benefit of the 3 dose regimens of AIN457 given over the course of 1 year
    • To allow for an adequate safety follow up (12 weeks post-study treatment) in patients prematurely discontinuing or completing study treatment in the extension study
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who have completed the entire treatment period of the 24 week core study
    2. Patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give a written, signed, and dated informed consent before any study assessment is performed.
    E.4Principal exclusion criteria
    1. Inability or unwillingness to undergo repeated subcutaneous injections
    2. Inability to comply with study or follow-up procedures.
    3. Any medical or psychiatric condition which, in the investigator’s opinion would preclude the participant from adhering to the protocol or completing the study per protocol.
    4. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
    5. Women of childbearing potential (WoCBP), defined as all women physiologically capable of becoming pregnant, UNLESS:
    • They are using simultaneously double barrier or two acceptable methods of contraception, (e.g., intra-uterine device plus condom, condom plus spermicidal gel, diaphragm plus condom, etc., hormone replacement as either oral or implantable is acceptable as one form), from the time of screening and for the duration of the study, through study completion and for 16 weeks after study drug discontinuation. [Note: Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods), spermicides alone without condoms or cervical caps and withdrawal are not considered acceptable methods of contraception.]
    • They are postmenopausal with an appropriate clinical profile (e.g, age appropriate, history of vasomotor symptoms) and had no regular menstrual bleeding for at least twelve (12) months prior to initial dosing. Menopause must be confirmed by a plasma FSH level of >40 IU/L at screening
    • They have undergone reliable surgical sterilization at least six (6) months prior to initial dosing. Surgical sterilization procedures should be supported with clinical documentation made available to the sponsor and/or Principal Investigator and noted in the Relevant Medical History / Current Medical Conditions section of the CRF.
    • Their career, lifestyle, or sexual orientation precludes intercourse with a male partner
    • Partners have been sterilized by vasectomy or other reliable means
    6. Male subjects must agree to use simultaneously two acceptable methods of contraception (e.g. condom plus spermicidal gel) for the entire duration of the study, up to the study completion visit, unless they have undergone a vasectomy more than six (6) months prior to first dosing. A vasectomy must be supported with clinical documentation made available to the sponsor and/or Principal Investigator and noted in the Relevant Medical History/ Current Medical Conditions sections of the CRF. Periodic abstinence or withdrawal are not acceptably adequate methods of contraception.
    Reliable contraception must be maintained in men and women throughout the study and for 16 weeks after study drug discontinuation.
    No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the study is to demonstrate the superiority of at least one of three dosing regimens of AIN457 versus placebo with respect to the primary efficacy variable.
    The primary null hypotheses to be tested are the following:
    H1: There is no difference in the proportion of patients with recurrence during the combined core and extension phase between patients treated with AIN457 300 mg every 2 weeks and placebo
    H2: There is no difference in the proportion of patients with recurrence during the combined core and extension phase between patients treated with AIN457 300 mg every 4 weeks and placebo
    H3: There is no difference in the proportion of patients with recurrence during the combined core and extension phase between patients treated with AIN457 150 mg every 4 weeks and placebo
    (versus the one-sided alternative hypothesis for each core AIN457 dose regimen that there is a difference in the proportion of patients with recurrence during the combined core and extension phase in favor of the core AIN457 dose regimen).
    The treatment difference will be analyzed using logistic regression with proportion of patients with recurrence during the combined core and extension phase as dependent variable, treatment, the stratification variables country (or region) and core baseline total immunosuppressive score level (≤5 or >5) as factors. For patients who early discontinue the extension phase and do not have a recurrence during either the core or extension phase, the event of recurrence will be imputed using the same method described in Section 9.4.2 of core protocol [CAIN457C2301].
    The primary analysis population for the confirmatory testing of the hypotheses will be the FAS. Multiplicity adjustment for the primary and key secondary efficacy variables will be performed as described in Section 9.5.1.3 of core protocol [CAIN457C2301].
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-01-15. Yes
    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 state36
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 232
    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 Decision2010-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-07-15
    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-Thu Apr 25 22:08:16 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA