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    Summary
    EudraCT Number:2008-002631-33
    Sponsor's Protocol Code Number:CAIN457A2209
    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:2008-07-25
    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 number2008-002631-33
    A.3Full title of the trial
    Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis
    A.3.2Name or abbreviated title of the trial where available
    CAIN457A2209
    A.4.1Sponsor's protocol code numberCAIN457A2209
    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 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/l milligram(s)/litre
    D.3.10.2Concentration typeup to
    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.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-17 of the IgG1-k-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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    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 9.1
    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
    Part 1: Evaluate efficacy of AIN457 at 6 weeks based on the proportion of patients achieving an ASAS20 response
    Part 2: To Evaluate the efficacy of lower doses of AIN457 at 6 weeks based on the change in BASDAI response.
    E.2.2Secondary objectives of the trial
    Evaluate proportion of patients achieving an ASAS20 response at other time points
    Evaluate proportion of patients achieving an ASAS40 response
    Evaluate proportion of patients achieving an ASAS 5/6 response
    Part 1 only: Evaluate response to treatment as measured by MRI of the spine
    Assess PK of AIN457 in ankylosing spondylitis patients
    Assess safety and tolerability of AIN457 in ankylosing spondylitis patients
    Assess effect of AIN457 on levels of total IL-17 in ankylosing spondylitis patients
    Assess change in BASMI scores (cervical rotation, maximal intermalleolar distance, lumbar lateral flexion, modified Schober index, tragus-to-wall distance)
    Assess change in ASAS core set (domains 1-6) as a continuous outcome measure
    Assess change in BASDAI and physician global assessment
    Assess HRQoL by using the Medical Outcome Short Form (36), Health Survey SF-36®, and (ASQoL).
    Assess the change in Maastricht Ankylosing Spondylitis Enthesis Score (MASES) and Leeds enthesis index (LEI)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females, aged 18-65 at time of consent.
    2. Patients with moderate to severe AS fulfilling the modified New York criteria for a
    diagnosis of AS and whose disease is not controlled on NSAIDS (on at least one NSAID over a period of at least 3 months at maximum dose). Minimum disease activity for inclusion of patients will be assessed based on the ASAS core set domains: back pain & nocturnal pain score ≥ 4 despite concurrent NSAID use, PLUS a BASDAI score ≥ 4. Elevated CRP or ESR are not mandatory for study inclusion.
    3. Female subjects must have negative pregnancy test results at screening and baseline. WoCBP must be using simultaneously double-barrier or two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc., hormone contraception 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 6 months post last dose of AIN457. Women on hormone contraception should be on this regimen for at least 2 months prior to study start.
    Postmenopausal females must have had no regular menstrual bleeding for at least
    two (2) years prior to initial dosing. If menopause is confirmed by a plasma FSH level of > 40 IU/L at screening, or consistent with menopause per local laboratory, pregnancy test will be required at screening, baseline, before the second infusion and monthly during the study.
    Female subjects who report surgical sterilization must have had the procedure 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 Principle Investigator and noted in the Relevant Medical History / Current Medical Conditions section of the CRF.
    If female subjects have male partners who have undergone vasectomy, the vasectomy must have occurred more than six (6) months prior to first dosing.
    Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    4. Male subjects willing to use simultaneously two acceptable methods of contraception (e.g. spermicidal gel plus condom) for entire duration of the study and at least 6 months post last dose of AIN457.
    5. Able to communicate well with the investigator, and to understand and comply with the requirements of the study. Understand and sign the written informed consent.
    6. No evidence of liver disease or liver injury as indicated by abnormal liver function tests such as SGOT (AST), SGPT (ALT), γ GGT, alkaline phosphatase, or serum bilirubin. The investigator should be guided by criteria as outlined under exclusion criteria.
    7. Patients with a history of immunization against influenza (within past 12 months) and/or history of pneumococcal vaccination will be included. If not already immunized,
    vaccination is allowed to be completed (during flu season only) and such patients may be included after a 3-week window post immunization. Immunizations with attenuated life virus should be postponed until after completion of the study.
    8. History or presence of psoriasis or inflammatory bowel disease will be recorded.
    E.4Principal exclusion criteria
    1. WoCBP who are not willing to follow the restrictions in inclusion criteria 3, are not allowed in the study. Men who are not willing to follow the restrictions in inclusion criteria 4 are not allowed in the study. Male/female patients who plan to conceive during the time course of the study and
    6 months post last infusion of AIN457 are not eligible.
    2. Participation in any clinical trial using investigational drug within 4 weeks prior to initial dosing or five half lives of the IMP, whichever is longer and for any other limitation of participation based on local regulations.
    3. For patients who were previously treated with TNF blockers, the washout
    periods will be required for these patients to be eligble to participate in the trial.
    - 6-month washout period prior to baseline for alefacept.
    - 3-month washout period prior to baseline for adalimumab and cerolizumab.
    - 2-month washout period for baseline for etanercept or infliximab.
    4. a) For patients who were previously treated with immunosuppressive agenst other than methotrexate (MTX), sulphasalazine (SSZ) and systemic corticosteriods, a 1 month washout period prior to baseline is required. Immunosuppressive agent include but are not limited to cyclosporine, mycophenolate, trocrolimus and 5-aminosalicylic acid (5-ASA).
    - Prednisone should be kept at a stable dose 4 weeks before baseline and throughout the study and not exceed 10mg/day.
    - MTX should be kept at a stable dose 4 weeks before baseline and throughout the study and not exceed 25mg/week.
    - SSZ should be kept at a stable dose 4 weeks before baseline and throughout the study.
    In case of previous leflunomide treatment, a wash out with oral cholestyramine might be considered as an alternative wash out procedure to increase the elimination of leflunomide. Based on the notion that cholestyramine reduces plasma levels of the active leflunomide metabolite by approximately 40% in 24 hours and by 49% in 48 hours, cholestyramine is to be given orally at a dose of 8 g t.i.d. daily for 10 days. The patient may then be dosed with study drug not earlier than 2 weeks after start of the cholestyramine wash out procedure.
    4. b) Patients who are on NSAIDS should be kept at a stable dose 4 weeks before baseline and throughout the study.
    5. Positive HIV: ELISA and Western blot test result, HBsAg or Hepatitis C test result.
    Any active systemic infection within the past 2 weeks including a positive chest X-ray.
    6. Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic,
    hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral,
    psychiatric, chronic inflammatory diseases with the exception of psoriatic arthritis or other disease which in the clinical judgment of the investigator would make the patient unsuitable for the trial.
    7. Liver disease or liver injury as indicated by abnormal liver function tests such as SGOT (AST), SGPT (ALT), γ-GGT, alkaline phosphatase, or serum bilirubin. The Investigator should be guided by the criteria specified in the protocol.
    8. Subjects with active or history of clinically significant cardiac abnormalities as specified in the protocol.
    9. History of renal trauma, glomerulonephritis, or patient with one kidney.
    10. History of malignancy (other than basal cell carcinoma or adequately treated carcinomain-situ of the cervix).
    11. Unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.
    12. Conditions associated with an immune-compromising condition such as recent major surgical procedure; or history of drug or alcohol abuse within the 6 months prior to dosing.
    13. PPD tuberculin skin test reaction of ≥ 10 mm at screening or within 6 months prior to the screening visit, according to national guidelines (further details and precautions are given in the protocol).
    14. Total WBC count which falls outside the range of 4500–11,000/μl, or platelets
    <100,000/μl at screening.
    15. History of severe hypersensitivity to any biological agents (antibody or soluble receptor), including serious allergic reaction (hypotension, wheezing, urticaria), lupus-like syndrome.
    16. Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing or longer if required by local regulation.
    17. Patients with acute or subacute anterior uveitis requiring specialty care by an
    ophthalmologist.
    18. Patients with a diagnosis of fibromyalgia.
    19. Patients with total ankylosis of the spine (end stage disease).
    20. Patients fulfilling criteria of psoriatic arthritis.
    21. Part 1 only :- Patients with metal implants (e.g. aneurysm clips), shrapnel or cardiac pacemakers.
    22. Part 1 only:- Patients who do not fit into the MRI scanner (e.g patients with obesity).
    23. Part 1 only :- Patients suffering from uncontrollable claustrophobia who can not tolerate the confines of the MRI scanner.
    E.5 End points
    E.5.1Primary end point(s)
    Part 1: Proportion of ASAS20 responders at week 6 .
    Part 2: Change in BASDAI response at week 6.
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Proteomics, metabonomics, soluble markers
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other No
    E.7.1.3.1Other 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 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 concerned2
    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
    LPLV
    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) No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    All patients who complete the study maybe offered to enter a separate extension study. Details to be defined in a separate protocol. This may provide long term safety and efficacy data as well as extended follow-up and access to AIN457 to those patients.
    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 Decision2008-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-12
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