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    Summary
    EudraCT Number:2015-001758-14
    Sponsor's Protocol Code Number:201677
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-07-15
    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 number2015-001758-14
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled,
    Parallel Group Study to Evaluate the Efficacy and Safety of
    Sirukumab in the Treatment of Patients with Giant Cell Arteritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the efficacy and safety of Sirukumab in the treatment of patients with Giant Cell Arteritis, using multiple sites, and an untreated patient group
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    A.4.1Sponsor's protocol code number201677
    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 SponsorGlaxoSmithKline Research and Development Limited
    B.1.3.4CountryUnited Kingdom
    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 supportGlaxoSmithKline Research and Development Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research and Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Helpdesk
    B.5.3 Address:
    B.5.3.1Street Address1-3 Iron Bridge Road
    B.5.3.2Town/ cityStockley Park West, Uxbridge, Middlesex
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44800783 9733
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameSirukumab
    D.3.2Product code GSK2973327
    D.3.4Pharmaceutical form Injection
    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 INNSirukumab
    D.3.9.2Current sponsor codeGSK2973327
    D.3.9.3Other descriptive nameCNTO 136
    D.3.9.4EV Substance CodeSUB26726
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    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) 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 Yes
    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.IMP: 2
    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 nameSirukumab
    D.3.2Product code GSK2973327
    D.3.4Pharmaceutical form Injection
    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 INNSirukumab
    D.3.9.2Current sponsor codeGSK2973327
    D.3.9.3Other descriptive nameCNTO 136
    D.3.9.4EV Substance CodeSUB26726
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Prednisone Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderJubilant Cadista Pharmaceuticals Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 namePrednisone
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisone
    D.3.9.3Other descriptive nameOver encapsulated prednisone
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Prednisone Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderJubilant Cadista Pharmaceuticals Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 namePrednisone
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisone
    D.3.9.3Other descriptive nameOver encapsulated prednisone
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    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 Prednisone Capsules
    D.2.1.1.2Name of the Marketing Authorisation holderJubilant Cadista Pharmaceuticals Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 namePrednisone
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisone
    D.3.9.3Other descriptive nameOver encapsulated prednisone
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    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
    Giant Cell Arteritis (GCA)
    E.1.1.1Medical condition in easily understood language
    Giant cell arteritis (GCA) is a condition in which medium and large arteries, usually in the head and neck, become inflamed.
    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 19.1
    E.1.2Level HLGT
    E.1.2Classification code 10047116
    E.1.2Term Vascular inflammations
    E.1.2System Organ Class 10047065 - Vascular 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 investigate the efficacy of sirukumab (100 mg q2w for 12 months) as compared to placebo, each
    administered in addition to a 6-month prednisone treatment regimen

    E.2.2Secondary objectives of the trial
    1. To assess cumulative prednisone doses in subjects treated with sirukumab plus prednisone as compared to placebo plus prednisone
    2. To investigate the efficacy of Sirukumab (100 mg q2w for 12 months) with 3-month prednisone treatment versus placebo with a 6-month prednisone treatment
    3. To investigate the efficacy of sirukumab (100 mg q2w for 12 months) with a 6-month prednisone treatment as compared to placebo with a 12-month prednisone treatment
    4. To investigate the efficacy of sirukumab (100 mg q2w for 12 months) with a 3-month prednisone treatment versus placebo with a 12-month prednisone treatment
    5. To investigate the efficacy of sirukumab (50 mg q4w for 12 months) as compared to placebo, each
    administered in addition to a 6-month prednisone treatment
    6. To investigate the efficacy of Sirukumab (50 mg q4w for 12 months) with a 6-month prednisone treatment as compared to placebo with a 12-month prednisone treatment
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A study to asses the utility of ultrasound imagaing in monitoring disease activity in GCA in a cohort of subjects with new onset GCA.

    Objectives:
    1. To explore the utility of vascular ultrasound (US) imaging assessment of inflammation in temporal and axillary arteries as an indicator of disease activity in a cohort of study subjects
    2. To explore the predictive value of ultrasound for clinical efficacy in GCA
    E.3Principal inclusion criteria
    1.Diagnosis of GCA defined by the following Revised GCA Diagnosis Criteria:
    •Age ≥50 years.
    •History of ESR ≥ 50 mm/hour or CRP ≥ 2.45 mg/dL (≥ 24.5 mg/L)
    •Presence of at least one of the following:
    oUnequivocal cranial symptoms of GCA (new onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, or otherwise
    unexplained mouth or jaw pain upon mastication).
    oUnequivocal symptoms of PMR, defined as shoulder and/or hip girdle pain associated with inflammatory stiffness.
    •Presence of at least one of the following:
    oTemporal artery abnormality on biopsy revealing features of GCA.
    oEvidence of large-vessel vasculitis by angiography or cross-sectional imaging, including but not limited to magnetic resonance angiography (MRA), computed tomography angiography (CTA), ultra sound (US) or positron emission tomography-computed tomography (PET-CT).
    oEvidence of temporal artery vasculitis on US (for US imaging qualified centers only)
    2.Active GCA within 6 weeks of Randomization (Baseline) where active disease is
    defined by an ESR ≥ 30 mm/hr or CRP ≥ 1 mg/dL (≥ 10 mg/L) AND the presence of at least one of the following:
    • Unequivocal cranial signs and symptoms of GCA (new onset localized headache, scalp or temporal artery tenderness, reduced or absent pulsation in temporal artery, stroke, scalp necrosis, pain over face/scalp arteries or otherwise unexplained mouth or jaw pain upon mastication [i.e., jaw claudication]).
    • Visual signs and symptoms associated with GCA, including ischemia-related vision loss [permanent vision loss due to AION, amaurosis fugax, episodic blurry vision], diplopia, scotoma nerve palsies, relative afferent papillary defects, central retinal artery occlusions.
    •Unequivocal symptoms of PMR, defined as shoulder and/or hip girdle pain associated with inflammatory stiffness.
    •Other features judged by the clinician investigator to be consistent with GCA or PMR flares (i.e., new or worsened extremity claudication, unexplained systemic symptoms such as fever of unknown origin).
    3.At screening, receiving prednisone treatment with a minimum dose of 20mg/day for the treatment of active GCA. Subjects not currently receiving prednisone treatment must commence dosing (minimum 20mg/day of prednisone) at the screening visit.
    4.Clinically stable GCA disease at baseline such that the subject is able to safely participate in the blinded prednisone taper regimen in the opinion of the investigator.
    5.Practicing acceptable methods of birth control as follows:
    Males:
    Male subjects with female partners of child bearing potential must
    comply with the following contraception requirements from the time of first dose of study medication until 4 months after the last dose of study medication:
    a. Vasectomy with documentation of azoospermia.
    b. Male condom plus female partner use of one of the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Childbearing potential.
    Male subjects should also not donate sperm from the time of first dose of study medication until 4 months after the last dose of study medication.
    Females:
    Female subjects of child-bearing potential must use one of the GSK
    Modified List of Highly Effective Methods for Avoiding Pregnancy in
    Females of Childbearing potential.
    6.No evidence of active or latent infection with Mycobacterium tuberculosis (TB), as defined by all of the following:
    •No history of active or latent TB infection.
    •A negative diagnostic TB test at Screening defined as a negative QuantiFERON Gold test or T-spot test (performed locally) (NB: 2 successive indeterminate QuantiFERON tests will be considered as a positive result). In cases where an initial indeterminate QuantiFERON test result may be related to sample processing issues, the second QuantiFERON test may be performed at
    either the local laboratory or the central laboratory at the discretion of the investigator. Re-testing is only permitted for indeterminate result. If the re-test also produces an indeterminate result, further re-testing to determine study eligibility is not permitted either at the local or central laboratory.
    •Chest radiograph (both posterior-anterior and lateral views unless local guidelines recommend only a single view), taken within 12 weeks prior to baseline or at Screening, and read locally by a qualified radiologist, with no evidence of current active or previous inactive pulmonary tuberculosis.
    NB: If there has been recent close contact with persons who have active TB prior to study enrolment the subject will be referred to a TB physician to undergo additional evaluation.
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria apply:
    1. Are pregnant or breastfeeding.
    2. Recent (within the past 12 weeks) or planned major surgery that would impact on study procedures or assessments.
    3. Organ transplantation recipients (except corneas within 3 months prior to baseline visit).
    4. Had prior treatment with any of the following:
    •Systemic immunosuppressives, including azathioprine, oral cyclosporine A,tacrolimus, mycophenolate mofetil, leflunomide, oral or parenteral gold, and IL-1ra (anakinra) within 4 weeks of baseline.
    •Biologic agents targeted at reducing TNF (including but not limited to infliximab, golimumab, certolizumab pegol, etanercept, yisaipu, and adalimumab)within 4-8 weeks of baseline, depending on the agent*.
    •Anti-IL6 (tocilizumab or any other anti-IL-6 agent) if:
     -Used within 8 weeks of randomization
     -Associated with a history of intolerance that precluded further
    treatment
     Associated with an inadequate response to 3 months of therapy
    B-cell depleting agents (eg, rituximab) within 12 months prior to baseline or longer if B cell counts have not returned to normal range or baseline levels
    Cytotoxic drugs such as cyclophosphamide, chlorambucil, nitrogen mustard, or other alkylating agents within 4 weeks of baseline.
    •Abatacept within 8 weeks of baseline.
    •Tofacitinib within 4 weeks of baseline.
    •Methotrexate use within 2 weeks of baseline.
    •Methylprednisolone > 100 mg/day IV (or equivalent) within 8 weeks of baseline.
    5. Regular or continuous systemic corticosteroid use for > 4 years.
    6. Requires continued or repeated use of systemic corticosteroids for conditions other than GCA.
    7. History of severe allergic reactions to monoclonal antibodies, human proteins, or excipients.
    8. Evidence of serious concomitant disease, which in the opinion of the investigator makes them unsuitable for participation in the study.
    9. Major ischemic event, unrelated to giant cell arteritis, within 12 weeks of screening.
    10. Marked baseline prolongation of QTc interval > 480 msec (QTcB or QTcF) or QTc > 500 msec in subjects with Bundle Branch Block**, history of Torsade de Pointes, family history of long QT syndrome, history of second or third degree heart block.
    ** The QTc should be based on averaged QTc values of triplicate ECGs obtained over a brief (e.g., 5-10 minute) recording period.
    11. Current liver disease that could interfere with the trial as determined by the physician investigator.
    12. History of or current active diverticulitis, inflammatory bowel disease, or other symptomatic GI tract condition that might predispose to bowel perforation.
    13. History of known demyelinating diseases such as multiple sclerosis or optic neuritis.
    14. Active infections, or history of recurrent infections or have required management of acute or chronic infections, as follows:
    •Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria,
    •History or suspicion of chronic infection (e.g joint infection).
    OR
    •Hospitalization for treatment of infection within 60 days of the baseline visit.
    OR
    •Use of parenteral (IV or IM) antimicrobials (antibacterials, antivirals, antifungals, or antiparasitic agents) within 60 days of baseline or oral antimicrobials within 30 days of baseline.
    15.Primary or secondary immunodeficiency.
    16.HIV infection (positive serology for HIV antibody), hepatitis C (positive serology for hepatitis C antibody confirmed positive by hepatitis C RNA PCR which is reflexively performed).
    17.Hepatitis B infection (positive test results for hepatitis B surface antigen or hepatitis B core antibody).
    18.Active malignancy or history of malignancy within previous 5 years (except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured).
    19.Laboratory abnormalities:
    •AST or ALT >2.0 × upper limit of normal (ULN).
    •Total bilirubin >ULN with the exception of Gilbert’s disease.
    •Platelet count <140 × 109/L.
    •Hemoglobin <8.5 g/dL.
    •WBC count <3.5 × 109/L.
    •ANC <2 × 109/L.
    •ALC <0.5 × 109/L.
    •Serum creatinine ≥ 2.0 mg/dL (SI: positive ≥ 177 μmol/L).
    20. Has received, or is expected to receive, any live virus or bacterial vaccination within 3 months before the first administration of study drug, during the study, or within 4 months after the last administration of study drug.
    21. Any other autoimmune disease (such as SLE, RA, inflammatory arthritis, other vasculitides, scleroderma, polymyositis, dermatomyositis or other similar systemic connective tissue diseases).
    22. Uncontrolled psychiatric or emotional disorder, drug abuse, alcohol abuse within past 3 years.
    *Please refer to the Study Procedures Manual (SPM) for guidance.
    E.5 End points
    E.5.1Primary end point(s)
    •Proportion of subjects in sustained remission at Week 52

    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    E.5.2Secondary end point(s)
    Part A: 52-week double blind treatment phase
    •Median and cumulative prednisone dose over time
    •Proportion of subjects in sustained remission at each time point of assessment from week 12 to week 52
    •Proportion of subjects in remission over time
    •Time to first GCA flare after clinical remission
    •Number of disease flares per patient over time
    •Proportion of subjects requiring hospitalizations for disease flare and number of hospitalizations for disease flare
    •Incidence of adverse events and serious adverse events, incidence of corticosteroid-related adverse events, changes in vital signs, hematology and
    clinical chemistry parameters
    •Patient and clinician reported outcomes including SF-36v2, EQ-5D (5L), FACITFatigue, Pain NRS, Steroid Impact PRO, HAQ-DI, PGIC, PtGA, PhGA
    •Change from baseline in ESR over time
    •Change from baseline in serum CRP over time
    •Serum concentrations of sirukumab
    •Serum anti-sirukumab antibodies
    •Change from baseline in IFN-γ and IL-17A
    •Change from baseline in serum markers of bone formation/resorption: CTX1/P1NP
    •Correlation of genetic markers with the safety and efficacy response to sirukumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week -6, 0, 2, 4, then every 4 weeks to 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 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 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) 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA62
    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
    Australia
    Belgium
    Bulgaria
    France
    Germany
    Hungary
    Italy
    Netherlands
    New Zealand
    Poland
    Spain
    United Kingdom
    United States
    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
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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: 173
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 31
    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 state68
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 141
    F.4.2.2In the whole clinical trial 204
    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)
    Upon study completion, decisions on treatment options for individual subjects will be at
    the discretion of the investigator.
    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 Decision2015-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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