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    Summary
    EudraCT Number:2013-002266-40
    Sponsor's Protocol Code Number:CAIN457ADE02
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-10-15
    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 ConcernedGermany - PEI
    A.2EudraCT number2013-002266-40
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multicenter, exploratory evaluation of surrogate markers of cardiovascular risk in patients with active chronic plaque-type psoriasis treated for 52 weeks with subcutaneous (s.c.) secukinumab (300 mg and 150 mg)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Exploratory evaluation of surrogate markers of cardiovascular risk in patients with active chronic plaque-type psoriasis
    A.3.2Name or abbreviated title of the trial where available
    CARIMA
    A.4.1Sponsor's protocol code numberCAIN457ADE02
    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 SponsorNovartis Pharma GmbH
    B.1.3.4CountryGermany
    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 supportNovartis Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH
    B.5.2Functional name of contact pointMedizinischer Infoservice
    B.5.3 Address:
    B.5.3.1Street AddressRoonstr. 25
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90429
    B.5.3.4CountryGermany
    B.5.4Telephone number+491802232300
    B.5.5Fax number+4991127312160
    B.5.6E-mailinfoservice.novartis@novartis.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 nameSecukinumab, 150 mg
    D.3.2Product code AIN457
    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.3.9.1CAS number 1229022-83-6
    D.3.9.2Current sponsor codeAIN457
    D.3.9.3Other descriptive nameSECUKINUMAB
    D.3.9.4EV Substance CodeSUB33242
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    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
    active chronic plaque-type psoriasis
    E.1.1.1Medical condition in easily understood language
    active chronic plaque-type psoriasis
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate flow mediated dilation (FMD) by Doppler ultrasound at week 12 in subjects in treatment arm A (300 mg Secukinumab) compared to the pooled group of patients in treatment arms C and D (placebo up to week 12).
    E.2.2Secondary objectives of the trial
    Cardiovascular Surrogate Markers:
    To evaluate flow mediated dilation by Doppler Ultrasound at weeks 4, 12, 24 and 52
    To evaluate arterial stiffness by pulse wave analysis and pulse wave velocity at weeks 4, 12, 24 and 52
    To evaluate soluble biomarkers from blood at weeks 4, 12, 24 and 52


    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    MRI sub-study

    objectives:
    To evaluate total plaque burden in the carotid artery and aorta as well as plaque composition in the carotid artery when measured in a complex plaque by 3.0 Tesla MRI at weeks 12 and 52 in a sub-study (40 patients)
    E.3Principal inclusion criteria
    1. Subjects 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 related activity is performed.
    2. Men or women at least 18 years of age at time of screening.
    3. Chronic moderate to severe plaque type psoriasis for at least 6 months prior to randomization with a PASI score ≥ 10 at randomization.
    4. Inadequate response, intolerance or contraindication to first-line conventional systemic psoriasis treatments as documented in the patient’s medical history or reported by the patient or determined by the investigator at screening. Relative contraindications such as interference of patient’s lifestyle with the treatment are accepted.
    5. At least one of the following to exclude chest infection and malignancy before initiation of a biologic immunomodulating therapy in accordance with current clinical guidelines:
    o Imaging of the chest (X-ray, computerized tomography (CT), or MRI) obtained within 12 weeks prior to screening, and evaluated by a qualified physician.
    o MRI of the chest obtained at screening and evaluated by a qualified physician.
    E.4Principal exclusion criteria
    1. Patients incapable of giving full informed consent.
    2. Forms of psoriasis other than chronic plaque-type at screening or randomization.
    3. Drug-induced psoriasis at randomization.
    4. Ongoing use of prohibited psoriasis and non-psoriasis treatments. Washout periods have to be adhered to.
    5. Use of other investigational drugs at the time of enrollment, or within 30 days or 10 half-lives of enrollment, whichever is longer.
    6. Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A or the IL-17A receptor.
    7. Women
    a. who are pregnant or breast feeding
    b. who are menstruating and capable of becoming pregnant and not practicing a medically approved method of contraception (Pearl Index <1) during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (serum) for all women is required with sufficient lead time before inclusion.
    8. Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy. Patients with psoriatic arthritis are not excluded.
    9. Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy.
    10. Known severe cardiovascular disease including but not limited to
    a. congestive heart failure with ejection fraction <50% and NYHA class II-IV.
    b. grade II or higher valvular disease.
    c. coronary artery disease requiring reperfusion during the study period.
    d. uncontrolled hypertension (repeated values of systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg despite maximally tolerated therapy). Patients who are at the time of screeningnot treated with maximal tolerated therapy may be rescreened after therapy has been successfully adjusted and well tolerated for at least 4 weeks.
    e. documented coronary heart disease in the medical history.
    f. symptoms or findings compatible with the presence of coronary artery disesase.
    11. Inability to suspend therapy with angiotensin-converting-enzyme inhibitors, nitrates, calcium channel inhibitors, and angiotensin-receptor blockers for at least 12 hours before visits.
    12. Subjects with a serum creatinine level exceeding 2.0 mg/dl at screening.
    13. Screening total white blood cell count <2,500/μl, or platelets <100,000/μl or neutrophils <1,500/μl or hemoglobin <8.5 g/dl.
    14. Chest X-ray, CT, or MRI with evidence of ongoing infectious or malignant process, obtained within 12 weeks prior to screening or after screening and prior to randomization, and evaluated by a qualified physician.
    15. Active systemic infections during the last two weeks prior to randomization or any infection that reoccurs on a regular basis.
    16. History of an ongoing, chronic or recurrent infectious disease including recurrent respiratory and/or urinary tract infections or evidence of tuberculosis infection.
    17. Past medical history record of infection with HIV, hepatitis B or hepatitis C prior to randomization.
    18. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
    19. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
    20. Current severe progressive or uncontrolled disease which in the judgment of the clinical investigator renders the subject unsuitable for the trial or puts the subject at increased risk.
    21. Patients, who have already been randomized into this trial earlier must not be included a second time.
    22. Study personnel or first degree relatives of investigator(s) must not be included in the study.
    23. Inability or unwillingness to undergo repeated venipuncture
    24. Subjects not willing to limit UV light exposure during the course of the study
    25. 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.
    26. History or evidence of ongoing alcohol or drug abuse, within the last six months before randomization.
    27. Plans for administration of live vaccines during the study period or 6 weeks prior to randomization.
    28. Upper thigh circumference >102 cm and/or upper arm circumference >49 cm.
    29. Current or medical history of diverticulitis and/or colitis.
    30. For the MRI sub-study, patients unwilling to undergo MRI assessment or with contraindications to MRI.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of flow mediated dilation by Doppler ultrasound in subjects in treatment arm A (300 mg Secukinumab) compared to the pooled group of patients in treatment arms C and D (placebo up to week 12).
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    E.5.2Secondary end point(s)
    Cardiovascular Surrogate Markers:
    To evaluate flow mediated dilation by Doppler Ultrasound
    To evaluate arterial stiffness by pulse wave analysis and pulse wave velocity
    To evaluate soluble biomarkers from blood
    To evaluate total plaque burden in the carotid artery and aorta as well as plaque composition in the carotid artery when measured in a complex plaque by 3.0 Tesla MRI in a sub-study (40 patients)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cardiovascular Surrogate Markers:
    Doppler Ultrasound at weeks 4, 12, 24 and 52
    pulse wave analysis and pulse wave velocity at weeks 4, 12, 24 and 52
    Evaluation of soluble biomarkers from blood at weeks 4, 12, 24 and 52
    3.0 Tesla MRI at weeks 12 and 52 in a sub-study

    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    exploratory biomarker study
    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.8.2.4Number of treatment arms in the trial4
    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 concerned23
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    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 months6
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state150
    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)
    When the subject leaves the study the investigator will discuss the different medications or possible alternatives that are available to treat the subject's psoriasis.
    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 Decision2013-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-21
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