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    Summary
    EudraCT Number:2012-005590-32
    Sponsor's Protocol Code Number:APCP-113
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-01-10
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2012-005590-32
    A.3Full title of the trial
    A double blind, placebo controlled Phase 2 study comparing the effects of ARA 290 on neuropathic symptoms of patients with type 2 diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study the effects of ARA 290 administered subcutaneously on nerve disease in patients with type 2 diabetes
    A.3.2Name or abbreviated title of the trial where available
    ARAND
    A.4.1Sponsor's protocol code numberAPCP-113
    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 SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLeiden University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number3171526 2301
    B.5.6E-maila.dahan@lumc.nl
    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 nameARA 290
    D.3.2Product code ARA 290
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInnate repair activator peptide
    D.3.9.2Current sponsor codeARA 290
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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 Yes
    D.3.11.13.1Other medicinal product typeSynthetic peptide
    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 placeboLyophilisate for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetes type 2: neuropathic symptoms
    E.1.1.1Medical condition in easily understood language
    Patients with type 2 diabetes often experience symptoms of nerve disease in the extremities.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    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
    The primary purpose of this double blind study is to determine the effect of ARA 290 on neuropathic symptoms in patients with type 2 diabetes.
    Amendment(Jul2014): 1) to determine insulin oscillations, 2) to determine whether ARA 290 administration increases insulin secreted to a glucose stimulus in a dose dependent manner as in the GK rat model and 3) whether extending the period of daily administration of ARA 290 to three months improves further glucose and lipid control and neuropathic symptoms in diabetic patients with small fiber neuropathy and whether these improvements are accompanied by improved systemic insulin oscillations
    E.2.2Secondary objectives of the trial
    Secondary objectives are to assess the effects of ARA 290 on general health and well-being, quantitative sensory testing, intra epidermal nerve fiber densities, cardiac autonomic neuropathy (as determined by R-R AND QT interval variability/changes in the ECG), 6 minute walk test, and visual acuity as determined by ETDRS chart evaluation in these patient populations. Additionally, the effect of ARA 290 on glucose control and microalbuminuria will be assessed.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Established diagnosis of diabetes mellitus type 2
    Screening HbA1c between 7.5 % and 10 % inclusive [retest of HbA1c allowed for patients with borderline values]
    Quantitative sensory testing shows allodynia and altered temperature thresholds
    Spontaneous discomfort level of 6 or greater on Pain Now (Pain Detect; 0 (least discomfort)-10 (worst discomfort))
    and small fiber neuropathy screening list (SFNSL; [1]) > 22,
    or spontaneous discomfort level on Pain Now (Pain Detect) < 5 and SFNSL > 44 at screening AND at first dosing visit.
    Discomfort defined as distal pain/discomfort plus one of the following: 1) paresthesia 2) burning/painful feet worsening at night, or 3) intolerance of sheets or clothes touching the legs or feet
    Be able to read and understand the written consent form, complete study-related procedures, and communicate with the study staff
    Be willing to comply with study restrictions
    Be willing to check in with the study center via the telephone
    Between 18 and 70 years of age (inclusive)
    Body Mass Index (BMI) < 40 kg/m2 (inclusive)
    If female of childbearing potential, a negative urine pregnancy test at screening and acceptable contraception will be maintained during the screening and dosing period and 1 month beyond. Acceptable contraception consists of hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the patient’s usual menstrual cycle period) before study entry, intrauterine device (IUD), or double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).
    Able to complete self-administered questionnaires (RAND-36, SFNSL, Pain Detect)
    Refrigerator at home for storage of study medication.

    Amendments (May2014): HbA1c >8% at screening, able to visit the hospital sober
    E.4Principal exclusion criteria
    Clinically relevant abnormal history of physical and mental health other than conditions related to diabetes, as determined by medical history taking (as judged by the investigator)
    Clinically relevant abnormal laboratory results, vital signs, or physical findings other than conditions related to diabetes (as judged by the investigator)
    Known clinically relevant abnormalities in ECG (as judged by the investigator)
    Episodes of significant hypoglycemia (as judged by the investigator)
    Illicit drug abuse or excessive alcohol consumption (as judged by the investigator)
    History of serious malignancy (as judged by the investigator)
    History of severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food (as judged by the investigator)
    Subjects that received a vaccination or immunization within the month prior to screening.
    Anti-TNF therapy or other biological anti-inflammatory agents administered within the 6 months prior to screening.
    Use of erythropoiesis stimulating agents within the two months prior to screening or during the trial
    Participation in an investigational drug trial in the 3 months prior to administration of the initial dose of study drug or more than 4 times per year
    Inadequate venous accessibility as judged by clinicians (physician or nurse)
    Inability or unwillingness to self-administer ARA 290 via subcutaneous injections (or not have access to home health care for assistance in administration; also see 6.9)
    If female, pregnant or breast-feeding
    Any other condition that in the opinion of the investigator would complicate or compromise the study, or the well being of the patient
    E.5 End points
    E.5.1Primary end point(s)
    Collection of adverse events, serious adverse events, and laboratory parameters
    Change in hemoglobin A1c at day 28 and 56 compared to baseline
    Change in the scores of the Small Fiber Neuropathy Screening List, Pain Detect, and RAND-36 (pain and physical function components) at days 28, 56, and 84 compared to screening

    Amendment (Jul2014): Insulin oscillations, Intravenous Glucose Tolerance Test over 2 hours with frequently-sampled plasma glucose and insulin concentrations with ARA 290 4 mg administered during the course of the GTT .
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pre-treatment, day 28, day 56 and day 84
    Insulin oscillations: sample every 2 minutes for one hour
    E.5.2Secondary end point(s)
    Change in quantitative sensory testing at day 28 baseline
    Change in intra epidermal nerve fiber density at day 28 baseline
    Change in the 6 minute walk test at day 28 versus baseline
    Change in visual acuity at day 28 versus baseline
    Change in heart rate variability (R-R and QT intervals) at day 28 versus baseline
    Change in visual acuity at 28 and 56 days versus baseline
    Additionally, the effect of ARA 290 on glucose control, C reactive protein, and microalbuminuria in patients with diabetes will be assessed.change in fasting glucose at day 28 versus screening
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pre-treatment, day 28, day 56
    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 No
    E.6.7Pharmacodynamic Yes
    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) 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 months9
    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 months9
    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: 88
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 88
    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 state88
    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 Decision2013-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-20
    P. End of Trial
    P.End of Trial StatusOngoing
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