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    EudraCT Number:2009-011591-30
    Sponsor's Protocol Code Number:CAIN457A2209E1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-20
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2009-011591-30
    A.3Full title of the trial
    An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCAIN457A2209E1
    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.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.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 for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAIN457
    D.3.9.3Other descriptive nameRecombinant human monoclonal antibody to Il-17 of the IgG1-k-class
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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. medicinal product typeRecombinant human monoclonal antibody to Interleukin-17 of the IgG1-k-class
    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
    Ankylosing spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of AIN457 in patients with moderate to severe ankylosing spondylitis receiving i.v. AIN457 initially up to 6 months (part1) with a possible extension of a further 6 months (part2) in patients who participated in the core CAIN457A2209 phase II proof-of-concept study
    E.2.2Secondary objectives of the trial
    To assess the immunogenicity of AIN457

    To assess the total IL-17 concentration in blood at steady-state

    To assess the pharmacokinetics of AIN457 at steady state
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients who participate and complete the core CAIN457A2209 study up to and including the EoS i.e. Visit 16 (Week 24), may enter the extension study upon signing informed consent.

    2. Patients who discontinued the core study due to unsatisfactory therapeutic effect at their Visit 14 (Week 16) or later may enter the extension study within three weeks of completing the study discontinuation visit of the core study, provided that at their discontinuation visit they meet the criteria below, Patients who do not enter the extension study within 3 weeks after completing the study discontinuation visit of the core study, will have an additional baseline visit (visit 18) and must meet the criteria below.
    a. There is no improvement (compared with the core study baseline) in two out of the
    following four domains: patient global assessment, pain, BASFI and the mean of the
    two morning stiffness questions from the BASDAI
    b. There is a deterioration (compared with the core study baseline) in one of the four
    domains (deterioration defined as >=20% worsening and an absolute worsening of
    >=1 unit)

    3. Women of childbearing potential must be using simultaneously double-barrier or two highly effective methods of contraception, (e.g. intra-uterine device plus condom,
    diaphragm plus condom, etc; hormone replacement as either oral or implantable is
    acceptable as one form), from the time of screening for the duration of the entire study, up to study completion and up to 16 weeks post last drug administration. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

    4. Male patients willing to use simultaneously two highly effective methods of contraception (e.g. intra-uterine device plus condom) for the duration of the entire study, up to study completion visit and up to 16 weeks post the last drug administration. Periodic abstinence and withdrawal are not acceptable methods of contraception.
    E.4Principal exclusion criteria
    1. Patients for whom continued treatment with AIN457 in the extension is not considered appropriate by the treating physician.

    2. Patients who were non-compliant or who demonstrated a major protocol deviation in the core CAIN457A2209 study.

    3. Patients who discontinued from the core CAIN457A2209 study before Visit 14
    (Week 16).

    4. Female patients who are pregnant or lactating

    5. Any active systemic infection within the past 2 weeks including a positive chest X-ray.

    6. Positive human immunodeficient virus (HIV: ELISA and Western blot) test result,
    Hepatitis B surface antigen (HBsAg) or Hepatitis C test result, where patients have been re-tested.

    The following Exclusion Criteria as defined in the core trial [CAIN457A2209] will continue to be valid with minor revisions:

    7. Positive Purified Protein Derivative (PPD) tuberculin skin test of ≥ 5 mm at baseline, (where patients have been re-tested). A positive PPD test will be defined using the MMWR 2000 guidance, summarized as criteria for tuberculin positivity by risk group. A PPD test should not be done in subjects who had a tuberculosis vaccination in the past. These subjects will be eligible to participate if – according to local guidelines – latent tuberculosis can be excluded. For those study sites using QuantiFeron test a positive test at baseline (where patients have been re-tested) will exclude the subject from the participation in the study. If the result for either PPD or QuantiFeron test is indeterminate the subject will be excluded.

    8. For previous use of immunosuppressive agents a wash-out period of at least 1 month or 5 half-lives, whatever is longer, is required. Immunosuppressive agent include but are not limited to cyclosporine, mycophenolate, tacrolimus, and 5-aminosalicylic acid (5-ASA).

    If on previous treatment with anti-TNF-α therapy (or other biological therapy), the
    following washout periods will be required for such patients to be eligible to participate in the trial.
    • Six (6)-months wash out prior to dosing for alefacept, rituxan and raptiva,
    • Three (3)-months washout prior to baseline for adalimumab and certolizumab,
    • Two (2)-months washout prior to baseline for etanercept and infliximab,
    • One (1) month washout prior to baseline for systemic immunosuppressants including, but not limited to azathioprine, cyclosporine, and leflunomide.

    Patients on concomitant prednisone, methotrexate (MTX) or SSZ can be included,
    • Prednisone should be kept at a stable dose 4 weeks before baseline and throughout the
    study and not exceed 10 mg/day.
    • MTX should be kept at a stable dose 4 weeks before baseline and throughout the
    study and not exceed 25 mg/week.
    • SSZ should be kept at a stable dose 4 weeks before baseline and throughout the study.

    9. Patients who are on NSAIDS should be kept at a stable dose 4 weeks before baseline and throughout the study.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability.
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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 EEA6
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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 2009-10-20. 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 50
    F.4.2.2In the whole clinical trial 60
    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)
    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 Decision2009-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-05
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