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    Summary
    EudraCT Number:2014-003985-25
    Sponsor's Protocol Code Number:SER150-P-C-001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-02-20
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-003985-25
    A.3Full title of the trial
    Multi-centre, randomized, double-blind, placebo-controlled, phase II study assessing in two sequential cohorts the safety, efficacy and tolerability of a 15 mg BID and a 30 mg BID doses of SER150TBS in well controlled type II diabetic patients with diabetic nephropathy and albuminuria in stable antidiabetic treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multi-centre, randomized, double-blind, placebo-controlled, phase II study of SER150TBS in type II diabetic patients.
    A.4.1Sponsor's protocol code numberSER150-P-C-001
    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 SponsorSerodus ASA
    B.1.3.4CountryNorway
    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 supportSerodus A/S
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEcron Acunova GmbH
    B.5.2Functional name of contact pointFrankfurt Office
    B.5.3 Address:
    B.5.3.1Street AddressHahnstr. 70
    B.5.3.2Town/ cityFrankfurt
    B.5.3.3Post codeD-60528
    B.5.3.4CountryGermany
    B.5.4Telephone number00496966 80 300
    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 nameSER150 ER
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeSER150TBS
    D.3.9.3Other descriptive nameSER150 ER capsules 15 mg
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 placeboCapsule, hard
    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
    type II diabetic patients with diabetic nephropathy and albuminuria
    E.1.1.1Medical condition in easily understood language
    type II diabetics
    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 19.0
    E.1.2Level HLT
    E.1.2Classification code 10012658
    E.1.2Term Diabetic complications renal
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine sequentially the safety of two different doses of SER150TBS administration (15 mg and 30 mg) repeated BID orally during 28 consecutive days, in well controlled type II adult diabetic patients with diabetic nephropathy and albuminuria, in stable antidiabetic treatment, by determining predefined safety hepatic and renal function parameters.
    To assess, in the mentioned setting, the efficacy of SER150TBS administration, determining the change in the amount of albuminuria and the amount of urinary thromboxane after 2 and 4 weeks of treatment as compared to that of placebo.
    E.2.2Secondary objectives of the trial
    To determine in the mentioned setting the tolerability of SER150TBS administration by assessing the observed adverse reactions.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females
    2. Aged 18 to 85 years, inclusively
    3. Female patient is either post-menopausal (presents at least a 12 month period of amenorrhea in women aged ≥ 55 years and two years in those aged < 55 years, and presents / presented clinical signs of menopause: hot flashes, irregular menstrual periods, vaginal drying, sleep disorders, depression and irritability) or surgically sterilized (hysterectomy or bilateral oophorectomy).
    4. General good health (ASA class 1 or 2)
    5. Well controlled type II diabetes diagnosis
    6. Stable antidiabetic treatment (unchanged during the last 3 months, including intensive insulin therapy)
    7. Diabetic nephropathy defined either by a positive biopsy or in its absence, by increased urinary albumin excretion in the absence of other renal disease or condition that would explain the albuminuria (for a diabetic patient presenting concomitantly a well-controlled hypertension, a hypertensive nephrosclerosis possibility would not be an exclusion criterion)
    8. Albuminuria, either micro (ACR 30-300 mg/g) or macro (ACR >300 mg/g)
    9. ALAT, or ASAT values not exceeding 1.5x ULN
    10. ALP, PT (or its international normalized ratio (INR)) and bilirubin within normal values
    11. eGFR equal or above 30 ml/min (CKD-Epi-formula)
    12. Glycated haemoglobin (HbA1c) ≤ 7.5%. A HbA1c value up to 8.5 % is acceptable in well controlled patients (according to the investigator’s opinion), particularly in elderly patients
    13. Normal blood pressure or well controlled hypertension (maximum 140 mm Hg systolic and 90 mm Hg diastolic)

    Ethical/Other:
    14. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
    E.4Principal exclusion criteria
    1. Recent history or ongoing liver disease, including viral infections (Hepatitis A/B/C/D/E, Coxsackie, or other viral infections of the liver)
    2. ALAT or, ASAT values exceeding 1.5x ULN
    3. ALP, PT (or its international normalized ratio (INR)) or bilirubin values exceeding the ULN
    4. Stroke within the last 3 months
    5. Systemic infections during the last month
    6. Severe renal failure (eGFR under 30 ml/min, CKD-Epi-formula)
    7. Chronic treatment with non-steroidal anti-inflammatory drugs (NSAID) including regular dose aspirin. Low dose aspirin treatment up to 100 mg/d is allowed.
    8. Any bleeding disorder or acute blood coagulation defect
    9. A history of gastric ulcers or any other organic lesion susceptible to bleeding
    10. Subjects who have undergone any kind of surgery in the last 2 weeks before IMP/placebo administration
    11. Others: allergy to the active substance or any of the excipients of the IMP
    12. Pregnant or lactating women
    13. Only for participation in the second cohort: Patients having participated in the first cohort
    14. Present participation in another clinical study or having participated in a clinical study requiring the administration of an investigational medicine, 6 months prior to enrolment (i.e. no interaction with the previous investigational medicine should be possible)
    15. History of serious cardiac disease, defined as myocardial infarction within three months of inclusion, congestive heart failure classified by the New York Heart Association as Class III or IV, poorly controlled or unstable angina, electrocardiographic evidence of acute ischemia, or clinically significant cardiac arrhythmias (i.e. the patient should have no symptoms and need no specific treatment, or have an appropriate treatment with successful control)
    Ethical/Other:
    16. Subjects committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
    17. Subjects dependent on the sponsor, investigators, personnel of the trial site or any other individual whose willingness to volunteer may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate
    E.5 End points
    E.5.1Primary end point(s)
    Effects of SER150TBS on kidney function, assessed by the change in the amount of albuminuria and the amount of urinary thromboxane after 2 and 4 weeks of treatment as compared to that of placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    screening visit V1 (day -14 to day -7), the mid-study visit V3 (day 14 ± 1), and the end of treatment visit V4 (day 28 ± 1)
    E.5.2Secondary end point(s)
    - serum creatinine and the corresponding eGFR (the central lab uses the CKD-Epi-formula)
    - urine protein to creatinine ratio.

    Additional parameter during the second cohort of patients
    For patients participating in cohort 2, the potential effect of SER150 on inflammation will be explored by determining (C-reactive protein (CRP)) in blood.
    E.5.2.1Timepoint(s) of evaluation of this end point
    screening visit V1 (day -14 to day -7), the mid-study visit V3 (day 14 ± 1), and the end of treatment visit V4 (day 28 ± 1).
    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) 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 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 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 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
    Last visit of the last subject undergoing the trial
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 47
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 47
    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 state94
    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 - Upon completion of the trial, patients should be treated at the
    discretion of the treating physician.
    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 Decision2015-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-21
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