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    Summary
    EudraCT Number:2012-004496-40
    Sponsor's Protocol Code Number:I5V-MC-TGAB
    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:2013-01-09
    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 number2012-004496-40
    A.3Full title of the trial
    Study of the Safety and Efficacy of LY3016859 after Multiple Intravenous Dosing in Diabetic Nephropathy Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the Safety and Efficacy of LY3016859 after Multiple Dosing in Diabetic Patients
    A.3.2Name or abbreviated title of the trial where available
    TGAB
    A.4.1Sponsor's protocol code numberI5V-MC-TGAB
    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 SponsorEli Lilly and Company
    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 supportEli Lilly and Company Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly and Company Ltd.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressNot Applicable - email contact alone
    B.5.3.2Town/ cityNot Applicable - email contact alone
    B.5.3.3Post codeNot applicable
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameNot yet avaliable
    D.3.2Product code LY3016859
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.2Current sponsor codeLY3016859
    D.3.9.3Other descriptive nameLA495; Anti-TGF-alpha/Epiregulin Antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 750
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic kidney disease associated with Diabetic nephropathy
    E.1.1.1Medical condition in easily understood language
    Kidney disease
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 100000004857
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10012678
    E.1.2Term Diabetic nephropathy NOS
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the safety and tolerability of multiple IV doses of LY3016859 in DN patients

    To evaluate the effect of multiple IV dosing of LY3016859 on change from baseline in proteinuria at 16 weeks in DN patients (Part B only)

    E.2.2Secondary objectives of the trial
    To investigate the effect of LY3016859 on change from baseline in proteinuria and albuminuria over time (Part B only)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Stable DKD while taking SOC, as defined by:
    a. Estimated glomerular filtration rate (eGFR) < 90 ml/min/1.73m2 as determined utilizing the Modification of Diet in Renal Disease (MDRD) equation (Levey et al. 2006)
    b. Taking ACE inhibitor or ARB at a stable dose for ≥ 2 months prior to randomization and agree to continue to take such throughout the duration of the study
    c. Type 1 or Type 2 diabetes on a stable treatment regimen and adequately controlled in opinion of investigator
    d. First morning protein creatinine ratio (PCR) at screening ≥ 400 mg/g (Part B only)
    2. Clinical chemistry labs within acceptable range for the patient population, as per investigator judgment
    3. Men and women of non-childbearing potential as determined by medical history
    a. Non-vasectomized male patients must agree to use a medically accepted method of contraception with all sexual partners during the study and for 90 days following the final dosing. Medically accepted effective forms of contraception may include condoms with contraceptive foam or having partners use diaphragms with contraceptive jelly or cervical caps with contraceptive jelly.
    b. Female patients must be postmenopausal or surgically sterile to particpate in this study. Postmenopausal is defined as females between age 45 to 75 years, inclusive, and either 12 months without a menstrual period (no follicle-stimulating hormone [FSH] test required) or 6-12 months without a menstrual period and FSH >40 IU/L
    4. 18-75 years old, inclusive and must weigh ≥ 50 kg at time of screening and dosing.

    5. Acceptable sitting blood pressure per the following American Heart Association guidelines
    a. Normal: Systolic Blood Pressure (SBP) <120 mmHg and Diastolic Blood Pressure (DBP) <80 mmHg
    b. Prehypertension: SBP 120 139 mmHg or DBP 80 89 mmHg
    c. High Blood Pressure (Hypertension) Stage 1: SBP 140 159 mmHg or DBP 90 99 mmHg
    6. Have given written informed consent prior to any study-specific procedures.
    7. Are reliable and willing to make themselves available for the duration of the study and are willing to follow site specific study procedures.
    8. Have venous access sufficient to allow blood sampling as per the protocol.
    E.4Principal exclusion criteria
    1. Patients with diagnosis of CKD other than DKD (hypertensive nephrosclerosis superimposed on DKD is acceptable)
    2. Patients with SBP >160 mmHg or DBP >100 mmHg,
    a. Individuals with Stage I BP elevation (SBP 140 159 mmHg or DBP 90 99 mmHg) on some occasions during study, may be acceptable, as long as only non-protein-lowering antihypertensives are administered/adjusted to achieve target BP goals (<140/90 mmHg).
    3. Patients with current use of (or within 2 weeks of enrollment), or projected need for a renin inhibitor or aldosterone antagonist, or a combination of ACEi/ARB or medications that confound the assessment of renal function, including lithium, immunosuppressives, anti-vascular endothelial growth factor (VEGF) therapies, and chronic nonsteroidal antiinflammatory drugs (NSAIDs); Patients who are unwilling to discontinue use of any medication with potential risk to mask a significant allergic response (e.g. systemic glucocorticoids) within 3 days of dosing;
    4. Patients in whom dialysis or transplantation is anticipated within 6 months of screening
    5. Patients with history of acute kidney injury within 3 months of screening
    6. Patients who are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational drug that has not received regulatory approval for any indication and/or have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives of the administered drug (whichever is longer) prior to dosing
    7. Patients who have previously completed or withdrawn from this study or any other study investigating LY3016859
    8. Patients with a diagnosis of Class III or IV congestive heart failure (as defined by the New York Heart Association); active/significant skin disorders (dermatitis, rash, acne, psoriasis), lung diseases (asthma, COPD, interstitial lung disease), or ocular disorders affecting sclerae, conjunctiva or iris (scleritis, conjunctivitis, keratoconjunctivitis, uveitis).
    9. Patients with an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study. In addition, subjects with the following findings will be excluded:
    a. Confirmed corrected QT (QTcF) interval > 450 msec for men and > 470 msec for women; additional ECGs may be performed if required
    b. Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular ectopic beats
    c. History of unexplained syncope
    d. Family history of unexplained sudden death or sudden death due to long QT syndrome
    e. T-wave configurations are not of sufficient quality for assessing QT interval, as determined by the investigator
    10. Patients with evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies; patients with a history of cirrhosis or hepatitis C or are positive for hepatitis C antibody at the screening visit; patients who are known to be hepatitis B surface antigen-positive or are positive for hepatitis B surface antigen at the screening visit
    11. Patients who are unwilling to discontinue use of Chinese herbs for at least 2 weeks prior to randomization and for the duration of their study participation.
    12. Patients who are investigator site personnel directly affiliated with this study and/or members of their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
    13. Patients who are Lilly or Chorus employees or contractors or their immediate family members
    14. Patients who are unwilling or unable to comply with the use of a data collection device to directly record data from the patient
    15. Patients who have donated blood of more than 500mL within the last 60 days prior to screening
    16. Patients who have an average weekly alcohol intake that exceeds 21 units per week or patients unwilling to stop alcohol intake within 48 h of each dosing visit (1 unit = 12 oz. or 360 mL of beer; 5 oz. or 150 mL of wine; 1.5 oz. or 45 mL of distilled spirits)
    17. Patients who, in the opinion of the investigator, show evidence of regular use of drugs of abuse.
    E.5 End points
    E.5.1Primary end point(s)
    Number of participants with clinically significant effects (Parts A and B) and change from baseline in proteinuria (Part B)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety: Baseline to 6 and 12 weeks post last dose for Parts A and B, respectively; Proteinuria: Baseline to 16 weeks
    E.5.2Secondary end point(s)
    Change from baseline in proteinuria and albuminuria
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to 16 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I Safety Study in Patients
    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 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 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
    Bulgaria
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    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 years0
    E.8.9.1In the Member State concerned months22
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months22
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 38
    F.4.2.2In the whole clinical trial 64
    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 Decision2013-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-08-15
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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