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    Summary
    EudraCT Number:2009-014834-22
    Sponsor's Protocol Code Number:CAIN457C2302
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-10-04
    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 ConcernedGreece - EOF
    A.2EudraCT number2009-014834-22
    A.3Full title of the trial
    A 28-week multicenter, randomized, double-masked, placebo controlled, dose-ranging phase III study to assess AIN457 versus placebo in inducing and maintaining uveitis suppression in adults with active, non-infectious, intermediate, posterior or panuveitis requiring immunosuppression (INSURE Study)
    A.3.2Name or abbreviated title of the trial where available
    INSURE
    A.4.1Sponsor's protocol code numberCAIN457C2302
    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 Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/060/09; EMEÀ /COMP/667262/2009
    D.3 Description of the IMP
    D.3.1Product namen.a.
    D.3.2Product code AIN457
    D.3.4Pharmaceutical form Powder for solution 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 placeboPowder for solution 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
    dose ranging phase III study to assess AIN457 versus placebo in inducing and maintaining uveitis suppression in adults with active, non-infectious, intermediate, posterior or panuveitis requiring immunosuppression
    MedDRA Classification
    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 three dose regimens of subcutaneous AIN457 compared to placebo when administered as an adjunctive therapy to standard-of-care immunosuppressive medications for inducing quiescence and maintaining quiescence during the withdrawal of concomitant immunosuppressive therapy in adults with active, non-infectious, intermediate uveitis, posterior uveitis or panuveitis.
    E.2.2Secondary objectives of the trial
    To determine if treatment with subcutaneous AIN457 can reduce or eliminate the need for standard of care immunosuppressive medications
    • To assess the safety of targeted IL-17 inhibition with AIN457 in patients with active uveitis affecting the posterior segment requiring standard-of-care immunosuppression
    • To evaluate the effect of subcutaneous AIN457 on macular edema, visual acuity, and quality of life when used as an adjunctive immunomodulatory therapy to standard-of-care immunosuppressive treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients eligible for inclusion in this study have to fulfill all of the following criteria:
    1. Male and female subjects ≥18 years of age. Where relevant, parents will also sign the informed consent according to local laws and regulations.
    2. Patients with diagnosis of chronic non-infectious intermediate uveitis, posterior uveitis or panuveitis in at least one eye
    3. Evidence of active intermediate, posterior or panuveitis (grade ≥ 2+ vitreous haze with or without the presence of anterior chamber cells) at screening and baseline in at least one eye
    4. Requirement for any of the following immunosuppressive therapies for the treatment or prevention of uveitis
    • Prednisone or equivalent ≥10 mg daily at any time within the past 3 months
    • ≥1 periocular injection or ≥1 intravitreal corticosteroid injection (e.g. triamcinolone) in the study eye within the past 6 months (the last injection must not have been given 6 weeks prior to screening)
    • Treatment with either cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate at any time within the past 3 months. (Patients treated with chlorambucil or cyclophosphamide within the past 5 years are ineligible for the study)
    • Patients not meeting the above specified criteria for immunosuppressive therapies are eligible for enrollment if they are intolerant to systemic immunosuppressive therapy as determined by the study investigator
    5. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed
    E.4Principal exclusion criteria
    Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
    Ocular concomitant conditions/disease, specified in the protocol, page 26
    Ocular treatments, specified in the protocol, page 26
    Systemic conditions or treatments, specified in the protocol, page 26
    Compliance/Administrative, specified in the protocol, page 27
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficay variable is the mean change in vitreous haze grade in the study eye from baseline to week 28
    Secondary endpoints:
    The key secondary efficacy variable is the change in immunosuppressive medication score from baseline to Week 28.
    The following are the other efficacy endpoints:
    • Proportion of responders with no recurrence of active intermediate, posterior, or panuveitis in the study eye at 28 weeks. Responders are defined as patients achieving quiescence (≤ 0.5+ anterior chamber cell grade and ≤ 0.5+ vitreous haze grade) in the study eye during 28 weeks. Responders may not experience any of the following during the 28- week treatment period:
    • A ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade in the study eye at any time during the study
    • A decrease in best corrected visual acuity ≥ 10 ETDRS letters compared to baseline or the previous visit attributed to ocular inflammation in the study eye.
    • An increase in concomitant immunosuppressive medication for the treatment of active intermediate, posterior or panuveitis for the study eye
    • Proportion of responders with no recurrence by visit
    • Mean time to rescue treatment
    • Proportion of patients receiving rescue therapy by visit
    • Mean time from achieving first quiescence to recurrence within a 16 week period
    • Mean time from achieving first quiescence to ≥2 step increase in vitreous haze
    • Mean time from achieving first quiescence to a decrease in best corrected visual acuity ≥ 10 ETDRS letters from baseline or prior study visit attributed to ocular inflammation in the study eye
    • Mean time to response and mean duration of response
    • Mean immunosuppressive score from baseline to 28 weeks
    • Mean change in best corrected visual acuity from baseline to 28 weeks
    • Mean change in foveal thickness from baseline to 28 weeks as measured by optical coherence tomography (OCT)
    • Change in Quality of Life/Patient reported outcome assessments from baseline at 28 weeks
    • Proportion of patients with >15 ETDRS letter gains or loss of visual acuity at 28 weeks
    • Mean change in anterior chamber cell grade from baseline to 28 weeks
    • Mean change in vitreous haze grade from baseline to 28 weeks
    • Assessment of the primary and secondary endpoints in the affected fellow non-study eye and per patient
    • Fundus photographs and fluorescein angiograms will be collected for later exploratory evaluation of change in leakage and manifestations of intraocular inflammation in the retina and choroid
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Patient will have completed the core study after having received a maximum of 26 weeks ± 3 days of study medication and completed of all the scheduled study assessments and procedures up to and including Visit 17.
    The study will be complete when all randomized patients have completed their final visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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 No
    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) No
    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 2010-10-04. 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 208
    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)
    patients will switch over to the extension study CAIN457C2302E1
    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 Decision2010-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-02-24
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