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    Summary
    EudraCT Number:2017-001191-30
    Sponsor's Protocol Code Number:RDEA594-401
    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:2017-09-21
    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 number2017-001191-30
    A.3Full title of the trial
    A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lesinurad 200 mg in Combination With a Xanthine Oxidase Inhibitor (XOI), Compared With an XOI Alone, in Subjects With Gout and Estimated Creatinine Clearance 30 to <60 mL/min Who Have Not Achieved Target Serum Uric Acid Levels on an XOI Alone
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 4 Study to evaluate the safety and efficacy of Lesinurad 200 mg in combination with a Xanthine Oxidase Inhibitor (XOI) compared with XOI alone in subjects with gout.
    A.3.2Name or abbreviated title of the trial where available
    Lesinurad in Subjects with Gout and Moderate Renal Impairment
    A.4.1Sponsor's protocol code numberRDEA594-401
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03226899
    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 SponsorIronwood 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 supportIronwood Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIronwood Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address301 Binney Street
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number001617 768 2625
    B.5.5Fax number001617 812 5946
    B.5.6E-mailRegulatoryAffairs@ironwoodpharma.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 Yes
    D.2.1.1.1Trade name Zurampic
    D.2.1.1.2Name of the Marketing Authorisation holderGrünenthal GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLesinurad
    D.3.2Product code RDEA594-401
    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 INNLesinurad
    D.3.9.1CAS number 878672-00-5
    D.3.9.3Other descriptive nameLESINURAD
    D.3.9.4EV Substance CodeSUB93370
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Gout and moderate renal impairment
    E.1.1.1Medical condition in easily understood language
    Gout
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018627
    E.1.2Term Gout
    E.1.2System Organ Class 10027433 - Metabolism and nutrition 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 evaluate the safety over 24 months of lesinurad 200 mg once daily (qd) when used in combination with a xanthine oxidase inhibitor (XOI), compared with XOI alone, in subjects with gout and moderate renal impairment (estimated creatinine clearance 30 to <60 mL/min) who have not reached target serum uric acid (sUA) levels on an XOI alone.
    E.2.2Secondary objectives of the trial
    Efficacy Objective:
    To evaluate the efficacy over 24 months of lesinurad 200 mg qd in combination with an XOI, compared with XOI alone, in subjects with gout and moderate renal impairment who have not reached target sUA levels on an XOI alone.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each subject must meet the following criteria to be enrolled in this study.
    1.Subject is able to understand the study procedures, the risks involved, and willing to provide written informed consent before the first study related activity.
    2.Subject is willing to adhere to the protocol schedule.
    3.Subject is ≥18 years and ≤85 years of age.
    4.Subject has a diagnosis of gout.
    5.Subject has moderate renal impairment with estimated creatinine clearance (eCrCl calculated by the Cockcroft-Gault formula using ideal body weight) 25.0 to ≤65.0 mL/min at Screening Visits 1 and 2 and an average eCrCl for both screening visits of 30.0 to <60.0 mL/min.
    6.Subject has been taking an XOI as urate-lowering therapy (ULT) treatment of gout for at least 4 weeks prior to Screening at a stable, medically appropriate dose, as determined by the Investigator. The minimum dose of allopurinol is 200 mg daily, and the minimum dose of febuxostat is the lowest approved dose per the local product label.
    7.Subject has a serum uric acid level ≥6.0 mg/dL (357 µmol/L) at Screening Visits 1 and 2.
    8.Subject is male or female; females must not be pregnant or breastfeeding and females of childbearing potential must agree to use non-hormonal contraception during the Screening Period and while taking IP.
    9.Subject has a body mass index <45 kg/m2.
    E.4Principal exclusion criteria
    Subjects who meet the following criterion will be excluded from the study:
    1.Subject had unstable angina, New York Heart Association class III or IV heart failure,
    myocardial infarction, or stroke within the last 6 months prior to randomization; or had a deep venous thrombosis within the previous 3 months prior to randomization.
    2.Subject has uncontrolled hypertension (defined as systolic pressure above 160 or diastolic pressure above 95 mm Hg at either Screening Visits 1 or 2).
    3.Subject has severe hepatic impairment (defined as Child-Pugh Class C) or is known human immunodeficiency virus (HIV) positive.
    4.Subject is a solid organ transplant recipient.
    5.Subject has a urine protein of 3+ or higher by dipstick by the central laboratory at Screening Visit 2.
    6.Subject has a history of glomerulonephritis.
    7.Subject is taking valpromide, progabide, valproic acid, or other known inhibitors of epoxide hydrolase, or subject is taking ranolazone, cyclosporine, azathioprine or mercaptopurine.
    8.Subject is receiving chronic treatment with more than 325 mg of salicylates per day.
    9.Subject is unable to initiate gout flare prophylaxis with colchicine or low-dose oral corticosteroids at Baseline.
    10.Subject is taking any other drug approved for use as a urate-lowering medication other than allopurinol or febuxostat (eg, pegloticase, probenecid, benzbromarone) within 4 weeks prior to Screening or during Screening.
    11.For subjects who will be taking colchicine for gout flare prophylaxis: Subject is taking, or anticipated to take during the first 6 months on study, moderate or strong CYP3A inhibitors (ie, verapamil or diltiazem, clarithromycin, and fluconazole) or grapefruit or grapefruit juice.
    12.Subject previously participated in a clinical study involving lesinurad (RDEA594) or verinurad (RDEA3170) and received active treatment or placebo, or has taken commercially-available lesinurad.
    13.Subject has a gout flare during the Screening Period.
    14.Subject is pregnant or breastfeeding.
    15.Subject consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).
    16.Subject has a history of malignancy and has been on active treatment within the previous 5 years prior to randomization with the exception of non-melanoma skin cancer, treated in situ Grade 1 cervical cancer, or treated ductal carcinoma in situ of the breast.
    17.Subject has been hospitalized (other than for elective surgery) or received intravenous contrast (eg, for CT scan or any angiography) within 1 month prior to Screening or during Screening.
    18.Subject has participated in a clinical trial within 8 weeks prior to Screening.
    19.Subject has any other medical or psychological condition, which in the opinion of the Investigator might create undue risk to the subject or interfere with the subject’s ability to comply with the protocol requirements or to complete the study.
    20.The maximum number of subjects in the eCrCl stratification subgroup has been reached.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints
    -Absolute and percent change from Baseline in eCrCl to Month 24.
    -Absolute and percent change from Baseline in eCrCl over the study period, including the last value on and off treatment.
    -Incidence of sCr elevations (≥1.5 × Baseline) over the study period.
    -Incidence of subjects meeting criteria (eg, based on sCr or eCrCl criteria) for treatment discontinuations over the study period.
    -Incidence of renal-related and kidney stone TEAEs and SAEs.
    -Prevalence of contributing factors to renal SAEs as adjudicated by the REAC.
    -Incidence of CEAC-adjudicated Major Adverse Cardiovascular Event (MACE): CV death, nonfatal myocardial infarction, and nonfatal stroke.
    -Incidence of CEAC-adjudicated MACE or hospitalization for unstable angina (MACE+).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 24 and over the study period.
    E.5.2Secondary end point(s)
    Exploratory end points:
    -Percent change from Baseline in the sum of the areas of all target tophi at scheduled visits, among subjects with ≥1 target tophus at Baseline.
    -Proportion of subjects who experienced complete resolution of at least 1 target tophus at any time during study, among subjects with ≥1 target tophus at Baseline.
    -Functional impairment assessed employing the Sheehan Disability Scale (SDS; individual domains as well as total functional impairment) at last on-study visit.
    -Work productivity as assessed employing the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP; absenteeism, presenteeism, work productivity loss, and activity impairment) at last on-study visit.
    -Health status as assessed employing the EuroQol Five Dimensions Questionnaire 3 level (EQ-5D-3L; both descriptive system and visual analogue scale) at last on-study visit.
    -Proportion of subjects with gout flares at each 3-month interval during the study
    period.
    Efficacy Endpoints
    -Key efficacy endpoint: Proportion of subjects who achieve sUA <6.0 mg/dL at Month 6.
    -Absolute and percent change from Baseline in sUA at each visit.
    -Proportions of subjects who achieve sUA <6.0 mg/dL at each visit.

    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 6 and last on -study visit
    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 No
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 trial2
    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 concerned22
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Czech Republic
    Hungary
    Poland
    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 years5
    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 years6
    E.8.9.2In all countries concerned by the trial months3
    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: 510
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state125
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 600
    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)
    All patients will return to their pre-study gout treatment regimen as prescribed by their physician. Patients receiving the placebo will remain on their current standard of care medications.
    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 Decision2017-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-12-18
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