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    The EU Clinical Trials Register currently displays   43243   clinical trials with a EudraCT protocol, of which   7156   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-000331-16
    Sponsor's Protocol Code Number:C-935788-050
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-05-08
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2014-000331-16
    A.3Full title of the trial
    A Phase 2, Multi-Center, Randomised, Double-Blind, Ascending-Dose, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of Fostamatinib in the Treatment of IgA Nephropathy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    N/A
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberC-935788-050
    A.5.4Other Identifiers
    Name:ClinicalTrials.govNumber:NCT02112838
    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 SponsorRigel Pharmaceuticals 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 supportRigel Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigel Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointDaniel Magilavy
    B.5.3 Address:
    B.5.3.1Street Address1180 Veterans Blvd
    B.5.3.2Town/ citySouth San Francisco, CA
    B.5.3.3Post code94080
    B.5.3.4CountryUnited States
    B.5.4Telephone number1650624-1372
    B.5.6E-maildmagilavy@rigel.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 nameFostamatinib 100 mg tablet
    D.3.2Product code R935788
    D.3.4Pharmaceutical form Film-coated 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 INNFostamatinib
    D.3.9.1CAS number 914295-16-2
    D.3.9.2Current sponsor codeR788 disodium hexahydrate
    D.3.9.3Other descriptive nameFOSTAMATINIB DISODIUM
    D.3.9.4EV Substance CodeSUB32625
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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: 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 nameFostamatinib 150 mg tablet
    D.3.2Product code R935788
    D.3.4Pharmaceutical form Film-coated 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 INNFostamatinib
    D.3.9.1CAS number 914295-16-2
    D.3.9.2Current sponsor codeR788 disodium hexahydrate
    D.3.9.3Other descriptive nameFOSTAMATINIB DISODIUM
    D.3.9.4EV Substance CodeSUB32625
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    IgA nephropathy (IgAN)
    E.1.1.1Medical condition in easily understood language
    N/A
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of fostamatinib administered orally for 24 weeks to subjects with IgA nephropathy, as measured by change in renal function and histology.
    E.2.2Secondary objectives of the trial
    To investigate the safety and tolerability of fostamatinib administered orally for 24 weeks to subjects with IgA nephropathy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed informed consent prior to any study specific screening
    procedures.
    2. Male or female between 18 to 70 years of age.
    3. Females must be either post-menopausal for at least 1 year,
    surgically sterile, or, if of child-bearing potential, must not be pregnant or lactating. If sexually active, must agree to use a highly effective method of birth control throughout the duration of the trial and for 30 days following the last dose.
    4. A pre-study renal biopsy obtained within 180 days prior to the initial study visit (Visit 1a) will be reviewed by a member of the central panel of renal pathologists to ensure subjects meet the following histologic entry criteria:
    • Consistent with IgAN
    • Mesangial hypercellularity score of > 0.5 (M1) and/or presence of endocapillary hypercellularity (E1) on renal biopsy (using the Oxford Classification)
    • < 50% of cortical area involved by tubular atrophy or interstitial fibrosis (T0 or T1)
    • < 50% glomerular crescents
    5. Treatment with an ACEi and/or an ARB for at least 90 days at a maximum approved (or tolerated) dose prior to Screening (Visit 1b). Subjects should remain on the same dose of ACEi or ARB during the treatment period (Visits 2-9).
    6. Proteinuria > 1 gm/day, sPCR > 100 mg/mmol (> 884 mg/g), or Spot Albumin/Creatinine Ratio > 70 mg/mmol at diagnosis of IgAN or any time prior to screening.
    7 Proteinuria > 0.50 gm/day [sPCR > 50 mg/mmol (> 442 mg/g)] at Screening (Visit 1b).
    8. Blood pressure controlled to ≤ 130/80 with angiotensin blockade with or without other anti-hypertensive agents. Subjects should be taking a maximum approved (or tolerated) dose of an ACEi or ARB before an additional anti-hypertensive agent is added. If additional antihypertensive therapy is required, other agents (beta blockers, calcium channel blockers, or diuretics) may be added. Patients may be
    reassessed if BP < 140/90, but > 130/80.
    9. Otherwise in stable health as determined by the Investigator based on medical history and laboratory tests during the screening period. See Exclusion Criteria for specific exclusions.
    10. In the Investigator's opinion, has the ability to understand the nature of the study and any hazards of participation and to communicate satisfactorily with the Investigator.
    E.4Principal exclusion criteria
    1. History of or active, clinically significant, respiratory,
    gastrointestinal (including pancreatitis), hepatic, neurological,
    psychiatric, musculoskeletal, genitourinary, dermatological, or other disorder that, in the Investigator's opinion, could affect the conduct of the study or the absorption, metabolism or excretion of the study drug.
    2. Have had any major cardiovascular event within the 180 days prior to randomisation, including but not limited to: myocardial infarction, unstable angina, cerebrovascular accident, pulmonary embolism, or New York Heart Association Class III or IV heart failure.
    3. Diagnosis or history suggestive of Henoch-Schonlein purpura.
    4. Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
    (using the MDRD equation) at the time of Screening (Visit 1b).
    5. A 50% decrease in eGFR from most recent pre-study clinic visit to Visit 1b.
    6. An absolute neutrophil count of < 1,500/μL, Hgb < 9 g/dL, ALT or AST of > 1.5x ULN, total bilirubin > 2.0 mg/dL at Visit 1b. The Investigator may reassess these laboratory abnormalities within 30 days after Screening (Visit 1b).
    7. Acute gastrointestinal symptoms (eg, nausea, vomiting, diarrhoea) at Baseline (Visit 2). The subject may be reassessed after full recovery from the acute gastrointestinal illness.
    8. Active bacterial or parasitic infections, including tuberculosis.
    9. Serologic results suggestive of active hepatitis B or hepatitis C (subjects may be included if confirmed hepatitis C recombinant immunoblot assay negative or hepatitis C virus RNA negative [qualitative]), or subjects with suspected human immunodeficiency virus (HIV).
    10. Use within 6 months prior to pre-study renal biopsy of
    cyclophosphamide, mycophenolate mofetil, azathioprine, or Rituximab (or other anti-B cell therapies). Those subjects who had been treated with an anti- B cell therapy must have a normal CD19 count by Visit 1b.
    11. Use of > 15 mg/day prednisone (or other corticosteroid
    equivalent). For those subjects taking corticosteroids for renal
    indication, the daily dose should not change from baseline (visit 2) to the end of study drug treatment (visit 9).
    12. Prior or current use of cyclosporine or tacrolimus.
    13. Have a clinically significant infection, or who are known to have an active inflammatory process (other than IgAN) at the time of Screening (Visit 1b) or Baseline (Visit 2). The subject may be reassessed after recovery from an acute infection.
    14. Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days or 5 half-lives (whichever is longer) of Screening (Visit 1a).
    15. Are unable or unwilling to follow instructions, including
    participation in all study assessments and visits.
    16. Have a history of alcohol or substance abuse that, in the judgment of the Investigator, may impair or risk the subject's full participation in the study.
    17. Have a condition or be in a situation that the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
    18. Have a known allergy and/or sensitivity to the study drug or its excipients.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the mean change from Baseline (Visit 2) of proteinuria (as measured by spot protein-creatinine ratio sPCR) at 24 weeks (Visit 9).
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    • Percentage of subjects with ≥ 50% reduction in sPCR from Baseline (Visit 2) at Week 24 (Visit 9).
    • Percentage of subjects with ≥ 30% reduction in proteinuria from Baseline (Visit 2) at 24 weeks (Visit 9).
    • Mean change from pre-treatment to post-treatment in mesangial hypercellularity on renal biopsies.
    • Mean change from pre-treatment to post-treatment in endocapillary hypercellularity on renal biopsies.
    • Mean change from pre-treatment to post-treatment in segmental sclerosis/adhesion score on renal biopsies.
    • Mean change from pre-treatment to post-treatment in global glomerulosclerosis score on renal biopsies.
    • Mean change from pre-treatment to post-treatment in tubulointerstitial scarring on renal biopsies.
    • Mean change from pre-treatment to post-treatment in cellular/fibrocellular crescent score on renal biopsies.
    • Mean change from Baseline (Visit 2) of eGFR at 12 weeks (Visit 7).
    • Mean change from Baseline (Visit 2) of eGFR at 24 weeks (Visit 9).
    • Mean change from Baseline (Visit 2) of proteinuria at 12 weeks (Visit 7).
    • Percentage of subjects with sPCR > 50 mg/mmol at 12 weeks (Visit 7).
    • Shift in haematuria (dipstick test) from Baseline (Visit 2) at 12 weeks (Visit 7).
    • Shift in haematuria (dipstick test) from Baseline of at 24 weeks (Visit 9).
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 and 24 weeks
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Hong Kong
    Singapore
    Switzerland
    Taiwan
    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
    Per section 7.10 (page 44) of the protocol: The study will end upon completion of all protocol procedures and achievement of study objectives
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    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) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 92
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects who have had at least a 40% decrease from Baseline (Visit 2) in proteinuria at Visit 9 and have tolerated study drug may be permitted to continue to receive extended treatment with study drug (fostamatinib or placebo) on the same double-blind treatment regimen until the results of this study are known. If subjects qualify, they may be transitioned to 150 mg fostamatinib bid and additional safety visits will occur at 2, 4, and 8 weeks from the transition.
    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 Decision2014-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-25
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