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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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).

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    Summary
    EudraCT Number:2022-001153-23
    Sponsor's Protocol Code Number:CAIN457I2401
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-10-17
    Trial 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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2022-001153-23
    A.3Full title of the trial
    A multicenter study of secukinumab, with a randomized double-blind, placebo-controlled withdrawal-retreatment period, to evaluate maintenance of response in participants with non-radiographic axial spondyloarthritis who achieved remission
    Studiu privind secukinumab de evaluare a menținerii răspunsului la participanții cu spondilartrită axială non-radiografică care au obținut remisiunea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of secukinumab to evaluate maintenance of response in participants with non-radiographic axial spondyloarthritis who achieved remission
    A.4.1Sponsor's protocol code numberCAIN457I2401
    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 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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma Services Romania S.R.L.
    B.5.2Functional name of contact pointRadu Boroghina - TMO Head Romania
    B.5.3 Address:
    B.5.3.1Street Address2 Gara Herastrau St., Equilibrium Complex, Building 1, Floor 10, Section E10.02, District 2
    B.5.3.2Town/ cityBucharest
    B.5.3.3Post code020334
    B.5.3.4CountryRomania
    B.5.4Telephone number004021312 99 01
    B.5.5Fax number004021312 99 07
    B.5.6E-mailradu_dan.boroghina@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 Yes
    D.2.1.1.1Trade name Cosentyx
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.2Product 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.3.8INN - Proposed INNSecukinumab
    D.3.9.1CAS number 1229022-83-6
    D.3.9.2Current sponsor codeAIN457
    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
    Non-radiographic axial spondyloarthritis
    E.1.1.1Medical condition in easily understood language
    nr-axSpA is a type of inflammatory arthritis affecting spine and pelvic joints but without the evidence of joint damage visible on x-ray
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076297
    E.1.2Term Non-radiographic axial spondyloarthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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 whether continuous secukinumab treatment is superior to placebo in preventing flares during Treatment Period 2 in participants who achieved a state of remission in Treatment Period 1
    E.2.2Secondary objectives of the trial
    -To evaluate efficacy of secukinumab on preventing the onset of flares in participants in a state of remission during Treatment Period 2 in participants who achieved a state of remission in Treatment Period 1
    -To assess overall safety and tolerability of secukinumab over time up to follow-up visit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participant 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.
    -Male or non-pregnant, non-lactating female participants at least 18 years of age.
    -Clinical diagnosis of axSpA AND according to ASAS axSpA criteria:
    a. Inflammatory back pain for at least 6 months
    b. Onset before 45 years of age
    c. Sacroiliitis on MRI (as assessed by central reader) with ≥ 1 SpA feature OR HLA-B-27 positive with ≥2 SpA features
    -Objective signs of inflammation at screening, evident by either
    •MRI with Sacroiliac Joint inflammation (as assessed by central reader)
    AND / OR
    •hsCRP > ULN (as defined by the central lab)
    -Active axSpA as assessed by total BASDAI ≥ 4 cm (0-10 cm) at baseline.
    -Spinal pain as measured by BASDAI question #2 ≥ 4 cm (0-10 cm) at baseline.
    -Total back pain as measured by VAS ≥ 40 mm (0-100 mm) at baseline.
    -Participants should have been on at least 2 different NSAIDs at the highest recommended dose for at least 4 weeks in total prior to baseline with an inadequate response or failure to respond, or less if therapy had to be withdrawn due to intolerance, toxicity or contraindications.
    -Participants who are regularly taking NSAIDs (including COX-1 or COX-2 inhibitors) as part of their axSpA therapy are required to be on a stable dose for at least 2 weeks before baseline.
    -Participants who have previously been on a TNFα inhibitor will be allowed entry into study only if they discontinued the treatment with TNFα inhibitor due to a reason other than efficacy (primary or secondary lack of efficacy, inadequate response) such as intolerance and only after appropriate wash-out period prior to baseline was observed:
    •4 weeks for etanercept – with a terminal half-life of 102 ± 30 hours
    •8 weeks for infliximab – with a terminal half-life of 8.0-9.5 days
    •10 weeks for adalimumab – with a terminal half-life of 10-20 days (average 2 weeks)
    •10 weeks for golimumab – with a terminal half-life of 11-14 days
    •10 weeks for certolizumab – with a terminal half-life of 14 days
    -Participants taking MTX (≤ 25 mg/week) or sulfasalazine (≤ 3 g/day) are allowed to continue their medication, must have taken it for at least 3 months and have to be on a stable dose for at least 4 weeks prior to baseline.
    -Participants on MTX must be on stable folic acid supplementation before baseline.
    -Participants who are on a DMARD other than MTX or sulfasalazine must discontinue the DMARD 4 weeks prior to baseline except for leflunomide, which has to be discontinued for 8 weeks prior to baseline unless a cholestyramine washout has been performed.
    -Participants taking systemic corticosteroids have to be on a stable dose of ≤ 10 mg/day prednisone or equivalent for at least 2 weeks before baseline.
    E.4Principal exclusion criteria
    -Participants with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally (radiological criterion according to the modified New York diagnostic criteria for AS) as assessed by central reader.
    -Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months of screening and evaluated by a qualified physician.
    -Taking high potency opioid analgesics (e.g., methadone, hydromorphone, morphine).
    -Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor or previous treatment with immunomodulatory biologic agents including those targeting TNFα (unless participants discontinued the treatment with TNFα inhibitor due to a reason other than efficacy [primary or secondary lack of efficacy, inadequate response] and only after appropriate wash-out period prior to baseline was observed).
    -History of hypersensitivity to the study drug or its excipients or to drugs of similar chemical classes.
    -Use of any investigational drug and/or devices within 4 weeks of baseline, or a period of 5 half-lives of the investigational drug, whichever is longer.
    -Any therapy by intra-articular injections (e.g., corticosteroid) within 4 weeks before baseline.
    -Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19).
    -Pregnant or nursing (lactating) women
    -Women of child-bearing potential unless they are using effective methods of contraception for the entire duration of the study or longer if required by locally approved prescribing information (e.g. 20 weeks in EU).
    -Active ongoing inflammatory diseases other than nr-axSpA that might confound the evaluation of the benefit of secukinumab therapy, including uveitis.
    -Active inflammatory bowel disease
    -History of fibromyalgia or an ongoing inflammatory arthritis of a different etiology than spondyloarthritis.
    -Underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions which in the opinion of the Investigator immunocompromises the participant and/or places the participant at unacceptable risk for participation in an immunomodulatory therapy.
    -History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratoses that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).
    -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.
    -History or evidence of ongoing alcohol or drug abuse, which in the opinion of the Investigator will prevent the participant from adhering to the protocol and completing the study.
    -History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by either a positive purified protein derivative (PPD) skin test or a positive QuantiFERON TB-Gold test at screening.
    -Active systemic infections during the last two weeks (exception: common cold) prior to Baseline.
    -Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C prior to baseline except for hepatitis C successfully treated and cured.
    -Plans for administration of live vaccines during the study period or 6 weeks prior to Baseline.
    -Inability or unwillingness to undergo repeated venipuncture (e.g., because of poor tolerability or lack of access to veins).
    -Donation or loss of 400 mL or more of blood within 8 weeks before Baseline.
    E.5 End points
    E.5.1Primary end point(s)
    -The proportion of participants remaining flare-free at Week 120
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 120
    E.5.2Secondary end point(s)
    -Time to flare during Treatment Period 2
    -Safety and tolerability demonstrated by assessing:
    -Adverse events (AEs) and serious adverse events (SAEs) (incidence, severity, and relationship with study drug)
    -Clinically significant changes in laboratory parameters and vital signs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 128
    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 No
    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.6.13.1Other scope of the trial description
    Tolerability
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Colombia
    Guatemala
    Malaysia
    Philippines
    Brazil
    Israel
    Mexico
    Thailand
    Viet Nam
    Belgium
    Czechia
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Romania
    Türkiye
    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 years7
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days23
    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: 340
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 226
    F.4.2.2In the whole clinical trial 340
    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)
    The investigator must provide follow-up medical care for all participants who prematurely discontinue the study or must refer them for appropriate ongoing medical care. This medical care may include initiating another treatment outside of the study as deemed appropriate by the investigator. This treatment may be continuing on commercially available secukinumab or initiating any non-biologic DMARD.
    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 Decision2022-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-31
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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