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    Summary
    EudraCT Number:2021-001256-34
    Sponsor's Protocol Code Number:CAIN457X12301
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-11-02
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-001256-34
    A.3Full title of the trial
    A randomized, parallel-group, double-blind, placebo-controlled, multicenter phase III study to investigate the efficacy and safety of secukinumab (Cosentyx) 300 mg administered subcutaneously in patients with active peripheral spondyloarthritis (pSpA).
    Studio randomizzato, a gruppi paralleli, in doppio cieco, controllato da placebo, multicentrico di fase III, per valutare l’efficacia e la sicurezza di secukinumab (Cosentyx) 300 mg somministrato sottocute in pazienti con spondiloartrite periferica attiva (pSpA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to demonstrate the efficacy and safety of secukinumab up to 224 weeks in subjects with active peripheral spondyloathritis (pSpA).
    Studio clinico per dimostrare l’efficacia e la sicurezza di secukinumab fino a 224 settimane in soggetti con la spondiloartrite periferica attiva (pSpA)
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberCAIN457X12301
    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 Farma S.p.A.
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni 1
    B.5.3.2Town/ cityOriggio (VA)
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number0296542862
    B.5.5Fax number029659066
    B.5.6E-mailinfo.studiclinici@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.3.1Product nameCosentyx
    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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    Peripheral Spondyloarthritis
    -
    E.1.1.1Medical condition in easily understood language
    Peripheral Spondyloarthritis
    -
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10052775
    E.1.2Term Spondyloarthropathies
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective and clinical question of interest of this study is to demonstrate the superiority of secukinumab compared to placebo based on Modified Peripheral SpondyloArthritis Response Criteria 40 (mPSpARC40) response at Week 16 in participants with active pSpA
    -
    E.2.2Secondary objectives of the trial
    To demonstrate the superiority of secukinumab compared to placebo
    based on:
    -Analysis Plan A (At Week 16):
    In participants with undifferentiated pSpA: mPSpARC40 response
    In participants with active pSpA: mPSpARC50 response, ACR 50 response, physician's global assessment of disease activity, SF-36 PCS, HAQ-DI, enthesitis count for enthesitis subset ; patient global assessment of disease activity & pain
    -Analysis Plan B (Week 16 and Week 52):
    In participants with undifferentiated pSpA: mPSpARC40 response at week 16 & 52
    In participants with active pSpA:
    At week 52: mPSpARC40 response
    At week 16 & 52: ACR 50 response
    At week 16: mPSpARC50 response ; physician's global assessment of disease activity, SF-36 PCS, HAQ-DI, enthesitis count for enthesitis subset, patient global assessment of disease activity & pain. The overall safety and tolerability of secukinumab compared to placebo as assessed by AEs, vital signs, clinical laboratory values, and adverse events monitoring.
    -
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participant meets ASAS criteria for classification of pSpA:
    · Participant must have current arthritis (asymmetric or predominantly in the lower limbs) or enthesitis (except for enthesitis only along the spine, sacroiliac joints and/or chest wall) or dactylitis.
    AND at least one of the following SpA features:
    · Anterior uveitis in the past confirmed by a qualified medical
    professional (participants with current ongoing uveitis are excluded from participation in the study).
    · Evidence of preceding infection (acute diarrhea or non-gonococcal urethritis or cervicitis less than 1 month before arthritis).
    · Human Leukocyte Antigen -B27 (HLA-B27) positivity.
    · Sacroiliitis on imaging; based on prior magnetic resonance imaging (MRI) or X-ray.
    OR at least 2 of the following SpA features:
    · Arthritis (past or present diagnosis), adequately documented and identified, or diagnosed by a qualified medical professional.
    · Enthesitis (any location, past or present diagnosis), adequately documented and identified, or diagnosed by a qualified medical professional.
    · Dactylitis (past or present diagnosis) adequately documented and identified, or diagnosed by a qualified medical professional.
    · Inflammatory back pain (past or present).
    · Family history for SpA.
    Diagnosis of pSpA with evidence of active disease as manifested by
    · Patient's global assessment of disease activity (0-100 VAS) >= 40 mm, and
    · Patient's global assessment of pain (0-100 VAS) >= 40 mm, and
    · At least one of the following:
    · >= 2 joints that are both tender and swollen
    · >= 2 sites of severe enthesitis as assessed by the investigator and >= 1 joint that is both tender and swollen
    · >= 2 digits with dactylitis and >=1 joint that is both tender and swollen not associated with dactylitis
    Participant should have been on at least 2 different non-steroidal antiinflammatory drugs (NSAIDs) at the highest recommended dose for at least 4 weeks in total prior to randomization with an inadequate response or failure to respond, or less if therapy had to be withdrawn due to intolerance, toxicity or contraindications.
    Participant taking methotrexate (<= 25 mg/week), or sulfasalazine (<= 3 g/day), and/or hydroxychloroquine (<= 400 mg/day) are allowed to continue their medication and must have taken it for at least 3 months and must be on a stable dose and route of administration for at least 4 weeks prior to randomization. Only one of these csDMARDs can continue during the study.
    Participant taking systemic corticosteroids must be on a stable dose of <= 10 mg/day prednisone or equivalent for at least 2 weeks before randomization.
    -
    E.4Principal exclusion criteria
    Current or previous diagnosis of any of the following:
    · Psoriasis (PsO) and/or nail changes consistent with PsO diagnosed by a qualified medical professional.
    · PsA diagnosed by a qualified medical professional.
    · Inflammatory bowel disease (IBD) diagnosed by a qualified medical professional.
    · axSpA by a qualified medical professional.
    Meets ASAS Axial Spondyloarthritis (axSpA) criteria.
    Score of >=2 on numerical rating scale (NRS)-score for total back pain and nocturnal back pain. (score 0–10).
    History of a confirmed diagnosis of any inflammatory joint disorder other than pSpA (e.g., rheumatoid arthritis, gouty arthritis, other crystalline arthritis, systemic lupus erythematosus, or any arthritis with onset prior to age 16 years such as juvenile idiopathic arthritis).
    Prior exposure to Tumor Necrosis Factor inhibitors (TNF-i's) or other biologics, immunomodulating agents, investigational or approved.
    Active ongoing inflammatory diseases other than pSpA that might confound the evaluation of the benefit of secukinumab therapy (e.g., uveitis).
    -
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants with active pSpA who achieve a mPSpARC40 response at Week 16 defined as meeting the following:
    - >= 40% improvement as well as a >= 20 mm absolute improvement from baseline in the VAS scores for patient's global assessment of disease activity and patient's global assessment of pain
    AND
    - >= 40% improvement in at least one of the following domains and no concurrent worsening in the other domains:
    1. SJC (76 joints assessed) and TJC (78 joints assessed) or
    2. Enthesitis count as measured by the SPARCC Enthesitis Index
    3. Dactylitis count as measured by LDI
    -
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks
    -
    E.5.2Secondary end point(s)
    Objectives associated with Analysis Plan A (Week 16)
    -Proportion of participants with undifferentiated pSpA achieving mPSpARC>=40 response at Week 16
    -Proportion of participants with active pSpA achieving mPSpARC>=50 at Week 16
    -Proportion of participants with active pSpA achieving ACR 50 at Week 16
    -Change in physician's global assessment of disease activity (0-100 mm VAS) from -Baseline to Week 16 in participants with active pSpA
    -Change in SF-36 PCS from Baseline to Week 16 in participants with active pSpA
    -Change in HAQ-DI improvement (change) from Baseline to Week 16 in participants with active pSpA
    -Change in enthesitis count from Baseline to Week 16 utilizing the SPARCC enthesitis index in participants with active pSpA.
    -Change in patient's global assessment of pain (0- 100 mm VAS) from Baseline to Week 16 in participants with active pSpA
    -Change in patient's global assessment of disease activity (0-100 mm VAS) from Baseline to Week 16 in participants with active pSpA
    -Assessment of Treatment Emergent Adverse Events (TEAEs) and changes in physical exams, Electrocardiogram (ECG)s, vital signs, laboratory assessments.
    Objectives associated with Analysis Plan B (Week 16 and Week 52)
    -Proportion of participants with active pSpA achieving mPSpARC>40 response at Week 52
    -Proportion of participants with active undifferentiated pSpA achieving mPSpARC>=40 response at Week 16
    -Proportion of participants with active undifferentiated pSpA achieving mPSpARC>=40 response at Week 52
    -Proportion of participants with active pSpA achieving mPSpARC>=50 at Week 16
    -Proportion of participants with active pSpA achieving ACR 50 at Week 16
    -Proportion of participants with active pSpA achieving ACR 50 at Week 52
    -Change in physician's global assessment of disease activity (0-100 mm VAS) from Baseline to Week 16 in participants with active pSpA
    -Change in SF-36 PCS from Baseline to Week 16 in participants with active pSpA
    -Change in HAQ-DI from Baseline to Week 16 in participants with active pSpA
    -Change in enthesitis count from Baseline to Week 16 utilizing the SPARCC enthesitis index in participants with active pSpA.
    -Change in patient's global assessment of pain (0–100 mm VAS) from Baseline to Week 16 in participants with active pSpA
    -Change in patient's global assessment of disease activity (0-100 mm VAS) from Baseline to Week 16 in participants with active pSpA
    -Assessment of TEAEs, and changes in physical exams, ECGs, vital signs, laboratory assessments.
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    End point for Analysis plan A is Week 16;
    End points for Analysis plan B are Week 16 and Week 52
    -
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    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
    Australia
    Brazil
    Canada
    China
    Colombia
    Guatemala
    India
    Philippines
    Russian Federation
    South Africa
    Thailand
    Turkey
    United States
    Vietnam
    Belgium
    Estonia
    Germany
    Hungary
    Italy
    Poland
    Slovakia
    Spain
    Czechia
    Argentina
    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 years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days14
    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: 292
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 324
    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)
    Participants on open-label secukinumab who the investigator believes are continuing to receive benefit from treatment, may also have post-trial access until secukinumab is available for peripheral SpA following
    product launch and subsequent reimbursement (where applicable), treatment discontinuation, or the benefit-risk profile is no longer positive.
    -
    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 Decision2021-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-08-23
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