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    Summary
    EudraCT Number:2011-001222-15
    Sponsor's Protocol Code Number:CL002_168
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-30
    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 ConcernedAustria - BASG
    A.2EudraCT number2011-001222-15
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis on Background Cyclophosphamide or Rituximab Treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to Evaluate the Safety and Efficacy of CCX168, a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV).
    A.4.1Sponsor's protocol code numberCL002_168
    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 SponsorChemoCentryx, Inc.
    B.1.3.4CountryUnited States
    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 supportChemoCentryx, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChemoCentryx, Inc.
    B.5.2Functional name of contact pointAntonia Potarca
    B.5.3 Address:
    B.5.3.1Street Address850 Maude Avenue
    B.5.3.2Town/ cityMountain View
    B.5.3.3Post codeCalifornia 9404
    B.5.3.4CountryUnited States
    B.5.4Telephone number+316 30892290
    B.5.5Fax number+1650210 2910
    B.5.6E-mailapotarca@chemocentryx.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 nameCCX168
    D.3.2Product code CCX168
    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 INNCCX168
    D.3.9.2Current sponsor codeCCX168
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (AAV) with mild-to-moderate renal involvement
    E.1.1.1Medical condition in easily understood language
    Autoimmune disease: Vasculitis (inflammation of blood vessels) caused by autoantibodies (autoantibodies are abnormal antibodies that attack one’s own cells and tissues)
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10047115
    E.1.2Term Vasculitis
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary safety objective is to evaluate the safety and tolerability of CCX168 in subjects with AAV on background cyclophosphamide or rituximab treatment.
    Primary efficacy objective is to evaluate the efficacy of CCX168 based on the Birmingham Vasculitis Activity Score (BVAS)
    E.2.2Secondary objectives of the trial
    1. Evaluation of the efficacy of CCX168 compared to standard of care (SOC) based on changes in renal disease activity parameters:
    a. eGFR (MDRD serum creatinine equation);
    b. Hematuria (central laboratory microscopic count of urinary RBCs); and
    c. Albuminuria (first morning urinary albumin:creatinine ratio);
    2. Assessment of changes in renal inflammatory activity based on urinary monocyte chemoattractant protein-1 (MCP 1):creatinine ratio and serum C-reactive protein concentration
    3. Assessment of the feasibility of reducing or eliminating the use of corticosteroids in the treatment of subjects with ANCA-associated vasculitis (AAV) without the need for rescue corticosteroid measures
    4. Assessment of health-related quality-of-life changes based on SF-36v2 and EQ-5D-5L
    5. Assessment of changes in VDI
    6. Assessment of changes in ANCA
    7. Assessment of changes in pharmacodynamics markers in plasma and urine ;
    8. Evaluation of the pharmacokinetic profile of CCX168
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Clinical diagnosis of granulomatosis with polyangiitis (Wegener’s), microscopic polyangiitis or renal limited vasculitis, consistent with Chapel-Hill consensus definitions (Jennette et al., 2013);
    2. Male and postmenopausal (lack of menses for at least 2 years without an alternative explanation) or surgically sterile female subjects, aged at least 18 years, with new (within 4 weeks prior to screening) or relapsed AAV where treatment with cyclophosphamide or rituximab would be required; If female under 50 years, the postmenopausal status should be confirmed by the relevant hormonal test. Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the three months after
    study completion; Adequate contraception is defined as resulting in a failure rate of less than 1% per year; acceptable methods include combined estrogen and progestogen (oral, intravaginal, or transdermal),
    or progestogen-only hormonal contraception (oral, injectable, or implantable), intra-uterine device, intrauterine hormone releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence;
    3. Positive indirect immunofluorescence (IIF) test for P-ANCA or C-ANCA, or positive ELISA test for anti-proteinase-3 (PR3) or anti-myeloperoxidase (MPO) at screening; If only the IIF assay is positive at screening, and none of the ELISA tests, there must be documentation in the study records of a positive ELISA assay in the past;
    4. Have at least one “major” item, or at least 3 non-major items, or at least 2 renal items on the BVAS version 3 (see section 11.3);
    5. eGFR ≥20 mL per minute (MDRD);
    6. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol; and
    7. Judged to be otherwise healthy by the Investigator, based on medical history, physical examination (including electrocardiogram [ECG]), and clinical laboratory assessments. Subjects with clinical laboratory values that are outside of normal limits (other than those specified in the Exclusion Criteria) and/or with other abnormal clinical findings that are judged by the Investigator not to be of clinical significance, may be entered into the study.
    E.4Principal exclusion criteria
    1.Severe disease as determined by rapidly progressive glomerulonephritis such that commencement of renal replacement therapy could be anticipated within 7 days, alveolar hemorrhage leading to Grade 3 or higher hypoxia (i.e., decreased oxygen saturation at rest, e.g., pulse oximeter <88% or PaO2 ≤55 mm Hg), hemoptysis, rapid-onset mononeuritis multiplex (Grade 3 or higher, leading to severe symptoms that limit self care activities of daily living or requiring an assistive device), or central nervous system involvement;
    2.Any other multi-system autoimmune disease including eosinophilic granulomatosis with polyangiitis (Churg Strauss)angiitis, systemic lupus erythematosus, IgA vasculitis (Henoch-Schönlein purpura), rheumatoid vasculitis, Sjögren’s disease, anti-glomerular basement membrane disease, or cryoglobulinemia;
    3.Medical history of coagulopathy or bleeding disorder;
    4.Received cyclophosphamide within 12 weeks prior to screening; if on azathioprine, mycophenolate mofetil, or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the cyclophosphamide dose on Day 1;
    5.Received intravenous corticosteroids, >3000 mg methylprednisolone equivalent, within 12 weeks prior to screening OR >500 mg methylprednisolone equivalent within 4 weeks prior to screening;
    6.Have been taking an oral daily dose of a corticosteroid of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to the screening visit. If on an oral corticosteriod at a daily dose of more than 10 mg prednisone equivalent at the time of screening, the oral dose needs to be reduced to a daily dose not exceeding 10 mg prednisone-eqiuvalent prior to Day 1;
    7.Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks provided B cell reconstitution has occurred (i.e., CD19 count > 0.01x10^9/L); received anti-TNF treatment, abatacept, alemtuzumab, IVIg, belimumab, tocilizumab, or plasma exchange within 12 weeks prior to screening;
    8.Symptomatic congestive heart failure requiring prescription medication, clinically evident peripheral edema of cardiac origin, poorly-controlled hypertension (systolic blood pressure >160 or diastolic blood pressure >100), history of unstable angina, myocardial infarction or stroke within 6 months prior to screening;
    9.History or presence of any form of cancer within the 5 years prior to screening, with the exception of excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis;
    10.Evidence of tuberculosis based on chest X rays performed during screening as part of the BVAS assessment;
    11.Positive HBV, HCV, or HIV viral screening test;
    12.Any infection requiring antibiotic treatment within 4 weeks prior to screening (except for prophylactic treatment for Pneumocystis carinii pneumonia [PCP] or treatment for suspected infection that instead turns out ot be a consequence of ANCA vasculitis e.g., pneumonitis);
    13.Received a live vaccine within 4 weeks of screening;
    14.WBC count less than 4000/uL or neutrophil count less than 2000/uL, or lymphocyte count less than 1000/uL
    15.Hemoglobin less than 9 g/dL (or 5.56 mmol/L) at screening;
    16.Evidence of hepatic disease; AST, ALT, alkaline phosphatase, or bilirubin > 3 x the upper limit of normal;
    17.Prothrombin time (PT) or partial thromboplastin time (PTT) above the normal reference limit;
    18.Clinically significant abnormal ECG during screening, e.g., QTc greater than 450 msec;
    19.Participated in any clinical study of an investigational product within 30 days prior to screening or within 5 half-lives after taking the last dose
    20.History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary safety endpoint is the subject incidence of adverse events.

    The primary efficacy endpoint is BVAS response.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 85 and Day169
    E.5.2Secondary end point(s)
    Safety
    1. Adverse events associated with glucocorticoids.
    2.Subject incidence of infections, serious infections, severe infections (i.e., Grade 3), and
    infections leading to subject withdrawal from the study;
    3.Change from baseline in all safety laboratory parameters;
    4.Change from baseline in vital signs;
    5.Incidence of clinically significant ECG changes from baseline.

    Efficacy:
    1. Renal response
    2. BVAS remission
    3. eGFR
    4. Hematuria
    5. Albuminuria
    6. Urinary MCP-1
    7. CRP
    8. Steroid rescue events
    9. VDI
    10. SF-36v2 and EQ-5D-5L
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 85 and Day 169
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    normal treatment of that condition.
    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 Decision2014-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-18
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