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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7263   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:2015-004575-74
    Sponsor's Protocol Code Number:CAIN457FDE03
    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:2016-02-18
    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 number2015-004575-74
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled multicenter study of Secukinumab (AIN457) to examine the clinical efficacy and the NSAID-sparing effect of Secukinumab over 16 weeks in patients with ankylosing spondylitis (ASTRUM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to examine the clinical efficacy and the NSAID-sparing effect of Secukinumab in patients with ankylosing spondylitis
    A.3.2Name or abbreviated title of the trial where available
    ASTRUM
    A.4.1Sponsor's protocol code numberCAIN457FDE03
    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 (MCC)
    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 number004991127312100
    B.5.5Fax number004991127312160
    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 Yes
    D.2.1.1.1Trade name Cosentyx
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameSecukinumab
    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.3.9.3Other 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
    Ankylosing Spondylitis
    E.1.1.1Medical condition in easily understood language
    Bechterew syndrome, Marie-Strümpell disease
    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 PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    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 demonstrate that the efficacy of Secukinumab 150 mg s.c. (with NSAID tapering) is superior to placebo based on the proportion of patients achieving an ASAS20 response at week 12. To show superiority, both Secukinumab treatment arms will be pooled and compared against placebo.
    E.2.2Secondary objectives of the trial
    • change from baseline in ASAS-NSAID score and in total BASDAI at week 12 is superior for Secukinumab 150 mg compared to placebo. Both Secukinumab treatment arms will be pooled.
    • efficacy of Secukinumab 150 mg at Week 12 (early and delayed NSAID tapering) and Week 16 (early NSAID tapering) is superior to placebo based on proportion of patients achieving ASAS20 response.
    • change from baseline in ASAS-NSAID score at Week 12 is superior for Secukinumab 150 mg (early and delayed NSAID tapering) as compared to placebo.
    • efficacy of Secukinumab 150 mg at Week 12 (early and delayed NSAID tapering) and week 16 (early NSAID tapering) is superior to placebo based on change from baseline in total BASDAI.
    • efficacy of Secukinumab 150 mg (early and delayed NSAID tapering) at Week 12 is superior to placebo based on change from baseline in health-related QoL as measured by SF-36 PCS.
    • compare both Secukinumab regimens concerning change from baseline in ASAS-NSAID score after 12 weeks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient 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
    2. Male or non-pregnant, non-lactating female patients at least 18 years of age
    3. Diagnosis of active AS with prior documented radiologic evidence (X-ray or radiologist’s report) fulfilling the Modified New York criteria for AS (Appendix 3)
    4. Active AS assessed by total BASDAI ≥ 4 (0-10) at baseline
    5. Spinal pain as measured by BASDAI Question 2 ≥ 4 cm on a 0-10 cm numeric rating scale at baseline
    6. Total back pain as measured by VAS ≥ 40 mm (0-100 mm) at baseline
    7. Patients should have been on at least 2 different NSAIDs at the highest recommended dose for at least 4 weeks in total in the past, prior to randomization, with an inadequate response or failure to respond, or less if therapy had to be reduced due to intolerance, toxicity or contraindications
    8. Patients must report regular intake of NSAIDs of at least 50% of the highest recommended dose at Screening. Patients with prior TNFα inhibitor therapy must report regular intake of NSAIDs of at least 50% of the highest recommended dose at baseline after the appropriate washout
    9. Patients are required to be on a stable dose of NSAIDs for at least 2 weeks before randomization
    10. Patients who have previously been on a TNFα inhibitor will be allowed entry into study after an appropriate wash-out period prior to randomization:
    • 4 weeks for Enbrel® (etanercept) – with a terminal half-life of 102 ± 30 hours (s.c. route)
    • 8 weeks for Remicade® (infliximab) – with a terminal half-life of 8.0-9.5 days (i.v. infusion)
    • 10 weeks for Humira® (adalimumab) – with a terminal half-life of 10-20 days (average 2 weeks) (s.c. route)
    • 10 weeks for Simponi® (golimumab) – with a terminal half-life of 11-14 days
    • 10 weeks for Cimzia® (certolizumab) – with a terminal half-life of 14 days
    11. Patients who have been on a TNFα inhibitor (not more than two) must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months prior to randomization or have been intolerant to at least one administration of an anti-TNFα agent. No more than 40% of patients may have previously received anti-TNFα agents
    12. Patients taking MTX (≤ 25 mg/week) or sulfasalazine (≤ 3 g/day) are allowed to continue their medication and must have taken it for at least 3 months and be on a stable dose for at least 4 weeks prior to randomization
    13. Patients on MTX must be on stable folic acid supplementation before randomization
    14. Patients who are on a DMARD other than MTX or sulfasalazine must discontinue the DMARD 4 weeks prior to randomization, except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine washout has been performed
    15. Patients taking systemic corticosteroids have to be on a stable dose of ≤ 10 mg/day prednisone or equivalent for at least 2 weeks before randomization
    E.4Principal exclusion criteria
    1. Chest X-ray or MRI with evidence of ongoing infectious or malignant process, obtained within 3 months of screening and evaluated by a qualified physician
    2. Patients taking high potency opioid analgesics
    3. Previous exposure to Secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor
    4. Use of any investigational drug and/or devices within 4 weeks of randomization, or a period of 5 half-lives of the investigational drug, whichever is longer or participation in another clinical study (interventional or non-interventional) in the same indication during enrollment in this study
    5. History of hypersensitivity to the study drug or its excipients or to drugs of similar chemical classes
    6. Any therapy by intra-articular injections within 4 weeks before randomization
    7. Any intramuscular corticosteroid injection within 2 weeks before randomization
    8. Patients previously treated with any biological immunomodulating agents, except those targeting TNFα
    9. Patients who have taken more than two anti-TNFα agents
    10. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents 11. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test
    12. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during entire study or longer if required by locally approved prescribing information.
    In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
    Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
    13. Active ongoing inflammatory diseases other than AS that might confound the evaluation of the benefit of Secukinumab therapy, including inflammatory bowel disease or uveitis
    14. Underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions, which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for participation in an immunomodulatory therapy
    15. Significant medical problems or diseases, including but not limited to the following: uncontrolled hypertension (≥ 160/95 mmHg), congestive heart failure (New York Heart Association status of class III or IV), uncontrolled diabetes, or very poor functional status unable to perform self-care
    16. History of clinically significant liver disease or liver injury as indicated by abnormal liver function tests such as SGOT (AST), SGPT (ALT), alkaline phosphatase, or serum bilirubin.
    17. History of renal trauma, glomerulonephritis, or patients with one kidney only, or a serum creatinine level exceeding 1.5 mg/dL (132.6 µmol/L)
    18. Screening total WBC count <3,000/µL, or platelets <100,000/µL or neutrophils <1,500/µL or hemoglobin <8.5 g/dL (85 g/L)
    19. Active systemic infections during the last two weeks prior to randomization (exception: common cold)
    20. 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 (the size of induration will be measured after 48-72 hours, and a positive result is defined as an induration of ≥ 5 mm or according to local practice/guidelines) or a positive QuantiFERON TB-Gold test as indicated in the assessment schedule in Table 6-1. Patients with a positive test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment according to local country guidelines must have been initiated
    21. Known infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C at screening or randomization
    22. 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)

    Other protocol-defined exclusion criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    To demonstrate that the efficacy of Secukinumab 150 mg s.c. (with NSAID tapering) is superior to placebo based on the proportion of patients achieving an ASAS20 response at week 12. To show superiority, both Secukinumab treatment arms will be pooled and compared against placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at week 12
    E.5.2Secondary end point(s)
    1. To demonstrate that the change from baseline in ASAS-NSAID score at week 12 is superior for Secukinumab 150 mg s.c. as compared to placebo. To show superiority, both Secukinumab treatment arms will be pooled and compared against placebo.
    2. To demonstrate that the efficacy of Secukinumab 150 mg s.c at week 12 is superior to placebo based on the change from baseline in the total BASDAI. To show superiority, both Secukinumab treatment arms will be pooled and compared against placebo.
    3. To demonstrate that the efficacy of Secukinumab 150 mg s.c. (Secukinumab from week 0 with NSAID tapering allowed from week 4; “delayed tapering”) at Week 12 is superior to placebo based on the proportion of patients achieving an ASAS20 response.
    4. To demonstrate that the efficacy of Secukinumab 150 mg s.c. (Secukinumab from week 4 with NSAID tapering allowed from week 4; “early tapering”) at Week 12 is superior to placebo based on the proportion of patients achieving an ASAS20 response.
    5. To demonstrate that the efficacy of Secukinumab 150 mg s.c. (Secukinumab from week 4 with NSAID tapering allowed from week 4; “early tapering”) at Week 16 is superior to placebo based on the proportion of patients achieving an ASAS20 response.
    6. To demonstrate that the change from baseline in ASAS-NSAID score at Week 12 is superior for Secukinumab 150 mg s.c. (Secukinumab from week 0 with NSAID tapering allowed from week 4; “delayed tapering”) as compared to placebo.
    7. To demonstrate that the change from baseline in ASAS-NSAID score at Week 12 is superior for Secukinumab 150 mg s.c . (Secukinumab from week 4 with NSAID tapering allowed from week 4; “early tapering”) as compared to placebo.
    8. To demonstrate that the efficacy of Secukinumab 150 mg s.c. (Secukinumab from week 0 with NSAID tapering allowed from week 4; “delayed tapering”) at Week 12 is superior to placebo based on the change from baseline in the total BASDAI.
    9. To demonstrate that the efficacy of Secukinumab 150 mg s.c. (Secukinumab from week 4 with NSAID tapering allowed from week 4; “early tapering”) at Week 12 is superior to placebo based on the change from baseline in the total BASDAI.
    10. To demonstrate that the efficacy of Secukinumab 150 mg s.c. (Secukinumab from week 4 with NSAID tapering allowed from week 4; “early tapering”) at Week 16 is superior to placebo based on the change from baseline in the total BASDAI.
    11. To demonstrate that the efficacy of Secukinumab 150 mg s.c. at week 12 is superior to placebo based on the change from baseline in health-related Quality of Life as measured by the SF-36 PCS.
    12. To demonstrate that the efficacy of Secukinumab 150 mg s.c. (Secukinumab from week 0 with NSAID tapering allowed from week 4; “delayed tapering”) at Week 12 is superior to placebo based on the change from baseline in health-related Quality of Life as measured by the SF-36 PCS.
    13. To demonstrate that the efficacy of Secukinumab 150 mg s.c. (Secukinumab from week 4 with NSAID tapering allowed from week 4; “early tapering”) at Week 12 is superior to placebo based on the change from baseline in health-related Quality of Life as measured by the SF-36 PCS.
    14. To compare between both Secukinumab regimens concerning the change from baseline in ASAS-NSAID score after 12 weeks of Secukinumab exposure (ASAS-NSAID index at Week 12 for “delayed tapering” vs. Week 16 for “early tapering”).
    E.5.2.1Timepoint(s) of evaluation of this end point
    at week 12 and week 16
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 No
    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 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 trial3
    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 concerned54
    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 years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    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: 184
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state190
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 190
    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)
    Subjects who has ended the participation in the trial will be treated according to the physician's discretion.
    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 Decision2016-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-03-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-09-24
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