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    Summary
    EudraCT Number:2017-003021-15
    Sponsor's Protocol Code Number:CL011_140
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-18
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2017-003021-15
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A controlled study to evaluate the safety and efficacy of the study drug, CCX140-B, in subjects with Focal Segmental Glomerulosclerosis (a type of glomerular disease)
    A.4.1Sponsor's protocol code numberCL011_140
    A.5.4Other Identifiers
    Name:INDNumber:134007
    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 organisationMedpace Germany GmbH
    B.5.2Functional name of contact pointRegulatory Submissions
    B.5.3 Address:
    B.5.3.1Street AddressTheresienhöhe 30
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code80339
    B.5.3.4CountryGermany
    B.5.4Telephone number+498956551780
    B.5.5Fax number00442033183827
    B.5.6E-mailregsubmissions@medpace.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.3.2Product code CCX140-B
    D.3.4Pharmaceutical form Tablet
    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 INNINN not available yet
    D.3.9.2Current sponsor codeCCX140-B
    D.3.9.4EV Substance CodeSUB30896
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Focal Segmental Glomerulosclerosis (FSGS)
    E.1.1.1Medical condition in easily understood language
    A type of glomerular disease (disease damaging the glomeruli, the filtering units inside the kidney where blood is cleaned) that causes scarring (sclerosis) in kidney.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067757
    E.1.2Term Focal segmental glomerulosclerosis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • The primary safety objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with FSGS with proteinuria.
    • The primary efficacy objective of this study is to evaluate the effect of CCX140-B treatment on urinary protein excretion in subjects with FSGS, as assessed by change from baseline in the urine protein to creatinine ratio (UPCR).
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of CCX140-B on renal function, as assessed by estimated glomerular filtration rate (eGFR) at Week 12 and 24;
    • To evaluate the effect of CCX140-B treatment on fraction of subjects achieving complete and partial renal remission (by 2 different partial remission definitions)
    • To evaluate the pharmacokinetic (PK) profile of CCX140-B in subjects with FSGS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects aged 18-75 years inclusive
    2. Urinary total protein:creatinine ratio (UPCR) ≥ 1 g protein/g creatinine at screening (or UPCR at 113 mg/mmol).
    3. Diagnosis of FSGS based on at least one of the following:
    o Renal biopsy demonstrating the FSGS lesion and characteristic clinical presentation and course
    o High risk genetic variant and characteristic clinical presentation and course
    4. Diagnosis of one of the following subtypes of FSGS:
    o Primary FSGS based on characteristic histopathology, medical history, and clinical course, or
    o FSGS secondary to a genetic variant associated with increased risk or severity, which may include NPHS1, NPHS2, WT-1, LAMB2, CD2AP, TRPC6, ACTN4 or INF2
    5. Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73m2, with eGFR calculated
    using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (using creatinine or cystatin C)
    6. The typical blood pressure of the patient should be clinically stable prior to enrollment and not exceed 145/95 mmHg.
    7. If using RAAS blockers, dose must be stable for a minimum of 4 weeks prior to Screening, and projected to remain stable through Study Week 12, unless adjustment is required for management of hypertension. Blood pressure should be clinically stable prior to enrollment.
    8. If using immunosuppressive or immunomodulatory therapy, dose must be stable for a
    minimum of 4 weeks prior to Screening, and projected to remain stable through Study
    Week 12
    9. If using glucocorticoids, dose must be stable for a minimum of 4 weeks prior to Screening and projected to remain stable through Study Week 12
    10. Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least 1 month after last dose of study drug. 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 one month after the last dose of study drug. Adequate contraception is defined as resulting in a failure rate of less than 1% per year (combined estrogen and progestogen [oral, intravaginal, or transdermal], or progestogen-only hormonal contraception (oral, injectable, or implantable), intra-uterine device, intra-uterine hormone releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence). In addition, a barrier method (i.e. cervical cap, diaphragm or condom) must be used during intercourse between a male subject and a female of child-bearing potential.
    11. Willing and able to give written Informed Consent and to comply with the requirements
    of the study protocol
    12. Judged to be otherwise fit for the study by the Investigator, based on medical history,
    physical examination, 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. Pregnant or nursing
    2. History of organ transplantation, including renal transplantation
    3. Currently on an organ transplant waiting list or there’s a reasonable possibility of getting an organ transplant within 6 months of screening
    4. Subjects who used of rituximab or other B-cell depleting monoclonal antibodies within 20 weeks prior to screening are excluded while subjects that used rituximab or other B-cell depleting monoclonal antibodies prior to 20 week of screening are allowed with confirmed recovery of the B-cell population to within normal range at the time of screening
    5. Plasmapheresis within 12 weeks prior to screening
    6. Body mass index (BMI) ≥40
    7. Participated in any clinical study of an investigational product within 12 weeks prior to
    screening, or within 5 half-lives after taking the last dose of investigational product
    8. Currently on dialysis or likely to require dialysis during the projected blinded treatment
    period of 12 weeks
    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 carcinoma in situ
    such as cervical or breast carcinoma in situ that has been excised or resected completely and
    is without evidence of local recurrence or metastasis
    10. Positive HBV, HCV, or HIV viral screening test. Subjects who have received highly effective therapy for HCV demonstrated to have negative viral titers for at least 6 months
    following discontinuation of treatment, will be considered to have a negative HCV screening test
    11. Renal disease associated with disorders other than FSGS (e.g. lupus nephritis, C3 glomerulopathy, proliferative glomerulonephritis, IgA nephropathy, reflux nephropathy,
    surgical segmental renal ablation, sickle cell disease ) that is active, or has significant risk of
    progressing during the course of the study
    12. Disorders other than those listed in Inclusion Criterion 4 that are associated with FSGS
    lesion (i.e. secondary FSGS such as single kidney, surgical segmental renal ablation, sickle cell disease, diabetic
    nephropathy; others) or histological collapsing variant subtypes of FSGS
    13. Evidence of tuberculosis based on interferon γ release assay (IGRA) within 6 weeks prior to screening
    14. Evidence of hepatic disease; AST, ALT, alkaline phosphatase >3x ULN, or total bilirubin > 2x ULN or INR > 1.5 x ULN at screening with the exception that isolated INR elevation in the absence of other significant liver enzyme abnormalities is explained by anticoagulant therapy, (e.g. warfarin).
    15. Clinically significant peripheral neuropathy.
    16. Hematologic abnormalities as follows: Hb < 8 g/dL, platelets < 50,000, ANC < 1000
    cells/μL) at baseline
    17. Clinically significant abnormal ECG during screening, e.g., QTcF greater than 450 msec
    18. History of alcohol or illicit drug abuse. Recreational use of cannabis is not excluded where legal.
    19. History of gastrointestinal conditions that may interfere with study medication compliance, e.g., severe gastroparesis, with regurgitation of food or oral medication
    20. Known hypersensitivity to CCX140-B or inactive ingredients of the CCX140-B tablets
    (including microcrystalline cellulose, starch, crospovidone, magnesium stearate, or silicon
    dioxide, or tartrazine)
    21. History or presence of systemic disorder other than FSGS that requires, or is expected to
    require, systemic glucocorticoids or immune modulators during the study; topical or inhaled
    glucocorticoids and immune modulators are not excluded
    22. 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
    23. Subjects taking strong CYP3A4 inducers (e.g., phenytoin, rifampicin, carbamazepine, St. John’s Wort) or strong CYP3A4 inhibitors (e.g., boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, and voriconazole) within two weeks prior to screening
    24. Subjects taking lithium, pamidronate or interferon; subjects taking non-steroidal anti-inflammatory agents (NSAIDS) chronically (intermittent, i.e., occasional NSAIDS for pain or fever is discouraged, but is not excluded)
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    Change from baseline in urine protein:creatinine ratio (UPCR) at week 12
    Safety:
    • Subject incidence of treatment-emergent adverse events, adverse events leading to study
    withdrawal, and serious adverse events;
    • Change from baseline and shifts from baseline in all safety laboratory parameters;
    • Change from baseline in vital signs;
    • Change form baseline in score on the ACTG BPNST
    • Clinically significant abnormal ECG findings
    • Physical examinations
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy:
    Week 12, Week 24
    Safety:
    Day1, Week12, Week16, Week24, Week28
    E.5.2Secondary end point(s)
    Efficacy:
    • Change from baseline in eGFR calculated by the CKD-EPI cystatin C
    equation, CKD-EPI Creatinine equation, CKD-EPI Creatinine-Cystatin C
    equation and MDRD Creatinine equation at Weeks 12 and 24
    • Proportion of subjects achieving complete renal remission at Weeks 12
    and 24 Completed Remission (includes all of the following):
    - Reduction in UPCR to < 0.3 g/g
    - Serum albumin within normal range
    - For subjects with abnormal serum creatinine levels at baseline, return
    to normal levels for that age group
    - For subjects with normal serum creatinine levels at baseline, final
    value within 20% of baseline levels
    • Proportion of subjects achieving partial remission at Weeks 12 and 24
    by the following two different definitions:
    - UPCR reduction of ≥ 50% from baseline and UPCR <3.5g/g
    - decrease in UPCR to less than 1.5 g/g and at least a 40% reduction in
    proteinuria from baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: Weeks 12, Week 24
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Exploratory
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Dose Ranging
    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 trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Canada
    Czech Republic
    France
    Germany
    Italy
    New Zealand
    Poland
    United Kingdom
    United States
    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
    LPLV
    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 months5
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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) Yes
    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: 10
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 40
    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)
    None
    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 Decision2018-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-19
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