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    Summary
    EudraCT Number:2018-003951-39
    Sponsor's Protocol Code Number:GS-US-223-1017
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-11-15
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-003951-39
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Selonsertib in Subjects with Moderate to Advanced Diabetic Kidney Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical trial to evaluate safety, and effectiveness of Selonsertib in Subjects with Moderate to Advanced Diabetic Kidney Disease
    A.4.1Sponsor's protocol code numberGS-US-223-1017
    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 SponsorGilead Sciences, 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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.5Fax number+441223897284
    B.5.6E-mailclinical.trials@gilead.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 nameSelonsertib
    D.3.2Product code GS-4997
    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 INNSELONSERTIB
    D.3.9.1CAS number 1448428-04-3
    D.3.9.2Current sponsor codeGS-4997
    D.3.9.3Other descriptive nameGS-4997, SEL
    D.3.9.4EV Substance CodeSUB188681
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 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
    Diabetic Kidney Disease
    E.1.1.1Medical condition in easily understood language
    Kidney Disease
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate whether SEL can slow the decline in kidney function, reduce the risk of kidney failure, or reduce the risk of death due to kidney disease in subjects with DKD
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    - To evaluate the effect of SEL on cardiovascular morbidity and mortality in subjects with DKD
    - To assess the safety and tolerability of SEL in subjects with DKD
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Genomic Testing
    Subjects may choose to participate in genomic testing. From subjects who agree to participate and provide consent, blood samples will be collected at the enrollment visit. If not obtained at the enrollment visit, the sample may be drawn at any time during the study.
    E.3Principal inclusion criteria
    1) Male or female between 18 (or ≥ age of majority in each jurisdiction if different than 18) and 80 years of age, inclusive
    2) Prior diagnosis of T2DM with diagnostic modalities as per local guidelines. Must have hemoglobin A1c (HbA1c) > 6% within 30 days prior to Enrollment (Visit A) or be on active treatment for T2DM for at least 6 weeks prior to Enrollment (Visit A)
    3) eGFRcr value calculated by central laboratory utilizing samples collected during Screening and prior to Enrollment (Visit A) of ≥ 20 mL/min/1.73 m² to < 60 mL/min/1.73 m² with albuminuria as measured by UACR
    4) Treatment with either an ACEi or ARB at the maximum labeled or tolerated dose deemed appropriate for the subject by the investigator and/or per local SOC for at least 6 weeks prior to Enrollment, with a stable dose for at least 2 weeks prior to Enrollment
    5) Subjects already receiving SGLT-2 inhibitors must be on a stable dose at least 2 weeks prior to Enrollment
    6) For females of childbearing potential (unless permanently sterile or post-menopausal, a negative serum pregnancy test at Screening
    7) For male and female subjects of childbearing potential who engage in heterosexual intercourse, agreement to abstain or use protocol specified method(s) of contraception
    8) Male subjects must refrain from sperm donation from the Screening visit through 30 days following the last dose of study drug
    9) Female subjects must refrain from egg donation or harvest from the Screening visit through 30 days following the last dose of study drug
    10) Subjects must refrain from blood product donation from the Screening visit through 30 days following the last dose of study drug
    11) Mean systolic blood pressure (SBP) must be <160 mmHg and mean diastolic blood pressure (DBP) must be <100 mmHg taken at two time-points at least five minutes apart within 30 days prior to Enrollment (Visit A)
    12) Required baseline laboratory data within 30 days prior to Enrollment (Visit A)
    13) Have either a normal 12-lead electrocardiogram (ECG) or ECG with abnormalities that are not considered to be clinically significant by the investigator within 30 days prior to Enrollment (Visit A)
    14) In the judgement of the investigator, participation in the study offers an acceptable benefit to risk ratio, taking into consideration the subject’s current DKD status, medical condition, and the potential benefits and risks of alternative treatments for DKD
    15) Willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions
    16) Willing and able to give informed consent prior to any study specific procedures being performed
    E.4Principal exclusion criteria
    1) HbA1c > 12.0% within 30 days prior to Enrollment (Visit A)
    2) In the investigator’s opinion, a condition other than T2DM is the primary etiology of DKD
    3) If < 30 years of age, any history of chronic insulin therapy or diabetic ketoacidosis
    4) Body mass index (BMI) > 50 kg/m2 at Enrollment (Visit A)
    5) UACR > 5000 mg/g on any measurement during Screening
    6) ESRD (i.e., peritoneal dialysis, hemodialysis, or history of kidney transplantation)
    7) Anticipated progression to ESRD (need for dialysis or receipt of kidney transplant) within 3 months after Enrollment (Visit A)
    8) Unstable CV disease as defined by any of the following:
    a) Myocardial infarction (MI), coronary artery bypass graft surgery, or coronary angioplasty within 3 months prior to Enrollment (Visit A)
    b) Transient ischemic attack or cerebrovascular accident within 3 months prior to Enrollment (Visit A)
    c) Hospitalization for heart failure within 3 months prior to Enrollment (Visit A)
    d) New York Heart Association (NYHA) Class IV congestive heart failure
    9) Diagnostic or interventional procedure that requires intravenous contrast agent within 30 days prior to Enrollment (Visit A) and/or planned during the study Run-in period
    10) History of a malignancy with the following exceptions:
    a) Carcinoma in situ of the cervix
    b) Basal or squamous cell cancer or other localized non-melanoma skin cancer that has been adequately treated and has not recurred for at least 1 year prior to Enrollment (Visit A)
    11) Pregnant or lactating females or planning to become pregnant or breastfeed during the study
    12) Concurrent use of a mineralocorticoid receptor antagonist (MRA) or direct renin inhibitor (DRI) in combination with an ACEi or ARB for at least 2 weeks prior to Enrollment
    13) Requiring chronic administration of prohibited medications as per protocol
    14) Participation in another investigational study within 1 month or within 5 half-lives of the prior investigational agent (whichever is longer) prior to Enrollment (Visit A)
    15) Concurrent participation in another therapeutic clinical study
    16) Prior participation in any clinical trial of SEL
    17) Known hypersensitivity to the study drug (SEL/placebo), the metabolites, or formulation excipients
    18) Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator’s opinion, could adversely affect the safety of the subject or impair the assessment of study results
    19) Presence of any condition that could, in the opinion of the investigator, compromise the subject’s ability to participate in the study, such as history of substance abuse, alcoholism, or a psychiatric condition
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint of this study is:
    • Clinical Endpoint: Time from randomization to the first occurrence of any of the following adjudicated events:
    - Confirmed ≥ 40% decline in eGFRcys from baseline, or
    - Kidney failure (dialysis for at least 90 days, kidney transplantation, or confirmed decrease in eGFRcys to < 15 mL/min/1.73 m2 for subjects without dialysis or kidney transplantation), or
    - Death due to kidney disease
    E.5.1.1Timepoint(s) of evaluation of this end point
    for Clinical endpoint: The final analysis of this clinical endpoint will be conducted at the global study end date when at least 861 events for the global primary clinical endpoint have been observed in the ITT Analysis Set.
    E.5.2Secondary end point(s)
    - Time from randomization to adjudicated CV death or hospitalization for heart failure
    - Time from randomization to the first occurrence of an adjudicated event in the CV composite endpoint (includes CV death, non-fatal MI, non-fatal stroke, or hospitalization for heart failure)
    - Time from randomization to adjudicated CV death
    - Time from randomization to adjudicated atrial fibrillation
    -Time from randomization to adjudicated CV death or adjudicated kidney failure (dialysis for at least 90 days, kidney transplantation, or confirmed decrease in eGFRcys to < 15 mL/min/1.73 m2 for subjects without dialysis or kidney transplantation)
    -Time from randomization to adjudicated all-cause death (death occurring during the study from any cause) or adjudicated kidney failure (dialysis for at least 90 days, kidney transplantation, or confirmed decrease in eGFRcys to < 15 mL/min/1.73 m2 for subjects without dialysis or kidney transplantation)
    E.5.2.1Timepoint(s) of evaluation of this end point
    If significance is reached for primary analysis of the EU primary clinical endpoint, the key secondary endpoints will be evaluated sequentially at a 0.049
    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 Yes
    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) Yes
    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 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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA228
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Chile
    China
    Colombia
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hong Kong
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Lithuania
    Malaysia
    Mexico
    Netherlands
    New Zealand
    Peru
    Philippines
    Poland
    Portugal
    Romania
    Russian Federation
    Singapore
    Slovakia
    South Africa
    Spain
    Sweden
    Switzerland
    Taiwan
    Thailand
    Turkey
    Ukraine
    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
    This is an event-driven study. The global study end date is defined as once the target of at least 861 adjudicated events in the global primary clinical endpoint have occurred and/or all subjects on study have completed end of study assessments and the 30 Day EOS Safety Follow-up visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    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 months0
    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: 990
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2310
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 782
    F.4.2.2In the whole clinical trial 3300
    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)
    After a patient has completed/terminated their study participation, long term care for the participant will remain the responsibility of their primary treating physicians.
    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 Decision2019-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-09
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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