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    Summary
    EudraCT Number:2017-003022-32
    Sponsor's Protocol Code Number:CL012_140
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-08-20
    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 number2017-003022-32
    A.3Full title of the trial
    An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An open, dose escalation study in patients with Primary Focal Segmental Glomerulosclerosis (FSGS - a type of glomerular disease causes scarring in the kidney) and Nephrotic Syndrom (collection of symptoms due to kidney damage)
    A.4.1Sponsor's protocol code numberCL012_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 number+442033183827
    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 INNnot available yet
    D.3.9.1CAS number 1100319-36-5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary 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 21.1
    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 Efficacy Objective is to evaluate the effect of CCX140-B on proteinuria in subjects with primary FSGS with nephrotic syndrome.
    E.2.2Secondary objectives of the trial
    1. Achievement of partial or complete remission of urine protein to creatinine ratio (UPCR) through Study Week 12 and through the end of treatment,
    2. Assessment of change from baseline in UPCR over time
    3. Assessment of time to, and proportion of subjects with achievement of partial remission
    4. Assessment of time to, and proportion of subjects with achievement of complete remission
    5. Assessment of time to rescue therapy, based on Investigator or physician initiation of glucocorticoids or new immunosuppressive agents or new major treatment modalities
    6. Changes over time in other laboratory parameters related to renal function, including:
    • Serum albumin
    • Creatinine
    • Cystatin C
    • eGFR, calculated by the CKD-EPI Cystatin C equation, CKD-EPI Creatinine equation, CKD-EPI Creatinine-Cystatin C equation and MDRD Creatinine equation.
    • urine albumin to creatinine ratio (UACR)
    • total 24 hour urine protein excretion
    7. Quality of Life endpoints using SF-36 v2 and EQ-5D-5L
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects aged 18 years and older
    2. Renal biopsy findings consistent with diagnosis of focal segmental glomerulosclerosis (FSGS), and consistent with primary FSGS based on presentation of histopathology, medical history, and clinical course; subjects with genetic risk factors with presentations that are otherwise consistent with primary FSGS may also be enrolled.
    3. Urinary total protein:creatinine ratio (UPCR) ≥ 3.5 g protein/g creatinine at screening, based on sample drawn from a 24-hour collection
    4. Hypoalbuminemia of less than 3.5 g/dL
    5. Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73m2, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD_EPI) equation (using creatinine or cystatin C)
    6. If used, RAAS inhibitor dose, including doses of angiotensin converting enzyme inhibitor and/or angiotensin II receptor antagonist must have been started at least 4 weeks prior to Study Day 1, and projected to remain stable throughout the course of the study unless adjustment is required for management of hypertension.
    7. Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least 5 half- lives 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.
    8. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
    9. 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. Histological FSGS subtype of collapsing variant
    5. Subjects who initiated, discontinued or changed dose of rituximab or other anti-CD20 monoclonal antibodies within 16 weeks (4 months) prior to screening are excluded. Subjects who initiated treatment with rituximab or other anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening are permitted if deemed safe by the investigator and only if they are intended to remain on continued, unchanged therapy at a dosing interval that has been documented to achieve continuous B cell depletion for the given patient. UPCR and other urine protein assessments up to 1 year prior to screening (if available) that were performed in these patients as part of the clinical routine should be recorded in the medical history.
    6. Subjects who discontinued Rituximab or other anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening without confirmed recovery of CD20+ B cell population to within normal range are excluded. Subjects who discontinued rituximab or other anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening with confirmed recovery of CD20+ B cell population to within normal range are permitted in the study. UPCR and other urine protein assessments up to 1 year prior to screening (if available) that were performed in these patients as part of the clinical routine should be recorded in the medical history.
    7. Subjects who initiated or increased the dose of calcineurin inhibitors, or other immunotherapy, within 12 weeks prior to screening are excluded; dose reductions to maintain calcineurin inhibitors at optimal safe levels are permitted. Subjects who initiated a treatment with calcineurin inhibitors, or other immunotherapy >12 weeks are permitted. UPCR and other urine protein assessments up to 1 year prior to screening (if available) that were performed in these patients as part of the clinical routine should be recorded in the medical history.
    8. Subjects taking glucocorticoids at dose greater than 10 mg/day prednisone equivalent within 4 weeks prior to screening are excluded.
    9. Plasmapheresis within 12 weeks prior to screening
    10. Body Mass Index (BMI) ≥ 40
    11. 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
    12. Currently on dialysis or likely to require dialysis during the study
    13. 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
    14. 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 weeks prior to screening
    15. Evidence of tuberculosis based on interferon γ release assay (IGRA), tuberculin purified protein derivative (PPD) skin test, or chest radiography done during screening or within 6 weeks prior to screening
    16. Evidence of hepatic disease; AST, ALT, alkaline phosphatase >2x 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).
    17. Clinically significant peripheral neuropathy
    18. Hematologic abnormalities as follows: Hb <8 g/dL, platelets <50,000, ANC <1000 cells/μL) at baseline
    19. Abnormality of ECG at screening, assessed by the Investigator as clinically significant (e.g. QTcF greater than 450 msec).
    20. History of alcohol or illicit drug abuse. Recreational use of cannabis is not excluded where legalized.
    21. History of gastrointestinal conditions that may interfere with study medication compliance, e.g., severe gastroparesis, with regurgitation of food or oral medication
    22. Known hypersensitivity to CCX140-B or inactive ingredients of the CCX140-B tablets (including microcrystalline cellulose, starch, crospovidone, magnesium stearate, or silicon dioxide)
    23. Renal disease associated with disorders other than FSGS (e.g. lupus nephritis, C3 glomerulonephropathy) that is active, or has significant risk of progressing to end state renal disease during the 12-week initial treatment phase of the study
    Full list of exclusion criteria is in the protocol
    E.5 End points
    E.5.1Primary end point(s)
    Evaluate the effect of CCX140-B on proteinuria in subjects with primary FSGS with nephrotic syndrome.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessed as a median reduction from baseline of urine protein to creatinine ratio (UPCR) of at least 20%, i.e. ≥ 20%, by week 12.
    E.5.2Secondary end point(s)
    Secondary endpoints include:
    • Achievement of Partial Remission (includes all of the following) reduction from baseline by ≥50 percent in UPCR reduction in UPCR to a level that is < 3.5 g/g at week 12 subject may not be a treatment failure
    • Achievement of Complete Remission (includes all of the following) at week 12
    - reduction in UPCR to < 0.3 g/g
    - serum albumin within normal range
    - for patients with abnormal serum creatinine levels at baseline, return to normal levels for that age group
    - for patients with normal serum creatinine levels at baseline, final value within 20% of baseline levels
    - subject may not be a treatment failure
    • Change from baseline of UPCR in subjects treated with CCX140-B over time
    • The proportion of subjects with partial remission at any time during the treatment period.
    • The proportion of subjects with complete remission at any time during the treatment period.
    • Time to Partial Remission (PR) or Complete Remission (CR)
    • Change from baseline in renal function, based on eGFR (calculated using the CKD-EPI Cystatin C equation (Dharnidharka VR, et al, 2002), the CKD-EPI Creatinine equation (Schwartz GJ, et al. 2016, Selistre L et al 2016), CKD-EPI Creatinine-Cystatin C equation (Stevens et al., 2008) and MDRD Creatinine equation (Levey et al. 1999, Levey et al. 2006) over time
    • Change over time in total 24 hour urine protein excretion
    • Change from baseline in serum albumin over time
    • Change in UACR from baseline over time
    • Time to investigator or physician initiation of rescue therapy including glucocorticoids, new immunosuppressive agents or new major treatment modalities (e.g. plasmapheresis, dialysis)
    • Duration between achievement of remission and relapse or treatment failure
    • Changes over time in Health Quality Assessment (SF-36 v2 and EQ-5D-5L)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy endpoints of this study will be assessed through Study Week 12 and through End of Treatment.
    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
    tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Canada
    France
    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
    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 months9
    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 months7
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 13
    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 Decision2019-10-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-06-24
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