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    Summary
    EudraCT Number:2017-004098-15
    Sponsor's Protocol Code Number:DS107G-04-UP1
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-11-23
    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 ConcernedLatvia - SAM
    A.2EudraCT number2017-004098-15
    A.3Full title of the trial
    A Randomised, Double-blind, Placebo-controlled, Phase 2 Study to Assess
    the Efficacy and Safety of Orally Administered DS107 in a once daily dose
    of 2g in Haemodialysis Patients with Moderate to Severe Uremic Pruritus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomised, Double-blind, Placebo-controlled, Phase 2 Study to Assess
    the Efficacy and Safety of Orally Administered DS107 in a once daily dose
    of 2g in Haemodialysis Patients with Moderate to Severe Uremic Pruritus
    A.4.1Sponsor's protocol code numberDS107G-04-UP1
    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 SponsorDS Biopharma
    B.1.3.4CountryIreland
    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 supportDS Biopharma
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDS Biopharma
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressTrintech Building, South County Business Park
    B.5.3.2Town/ cityLeopardstown
    B.5.3.3Post codeDublin 18
    B.5.3.4CountryIreland
    B.5.6E-mailk.kelly@dsbiopharma.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 nameDihomo-Gamma-Linolenic Acid, DGLA
    D.3.2Product code DS107G
    D.3.4Pharmaceutical form Capsule, soft
    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 INNnot applicable
    D.3.9.3Other descriptive nameDIHOMO-GAMMA-LINOLENIC ACID (DGLA)
    D.3.9.4EV Substance CodeSUB77517
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    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
    Moderate to Severe Uremic Pruritus
    E.1.1.1Medical condition in easily understood language
    Moderate to Severe Uremic Pruritus
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10060884
    E.1.2Term Uremic pruritus
    E.1.2System Organ Class 100000004858
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of orally administered DS107 versus placebo, in
    the treatment of adult haemodialysis patients with moderate to severe
    Uremic Pruritus (UP).
    E.2.2Secondary objectives of the trial
    To assess the safety of orally administered DS107 versus placebo, in
    adult haemodialysis patients with UP.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
     Limited pharmacokinetics of dihomo-gamma-linolenic acid (DGLA) at Baseline, Week 2, Week 4 and Week 12 (selected centres, only) with blood withdrawals at trough, 4 hours, 23 hours and 24 hours post investigational medicinal product (IMP) administration.

     Total fatty acid analysis (selected centres only) with samples to be taken at Baseline, Week 4 and Week 12.
    E.3Principal inclusion criteria
    1. Male or female patients who are aged 18 years and older on the day of
    signing the informed consent form (ICF).
    2. Patients who are on stable haemodialysis 3 times a week for at least 3
    months prior to screening with a urine production of less than 300 ml
    per day.
    3. Patients with continued (uncontrolled) pruritus despite standard of
    care in the institution.
    4. Patients with severe pruritus, as determined by qualifying mean worst
    NRS score in a day of ≥5 (on 11 point NRS) at the screening visit.
    5. Female patients and male patients with female partners of child
    bearing potential must use adequate contraception or have a sterilised
    partner for the duration of the study. Adequate contraception is defined
    as: systemic hormonal contraceptives, intrauterine device or agree to
    sexual abstinence. Hormonal contraceptives must be on a stable dose for
    at least one month before baseline.
    6. Patients whose pre-study clinical laboratory findings do not interfere
    with their participation in the study, in the opinion of the Investigator.
    7. Patients who are able to communicate well with the Investigator, to
    understand and comply with the requirements of the study, and
    understand and sign the written informed consent.
    E.4Principal exclusion criteria
    1. Patients who are known to be non-compliant with dialysis treatment
    (i.e., has missed more than 2 dialysis sessions in the past 2 months
    because of non-compliance).
    2. Patients who are anticipated to receive a kidney transplant during the
    study.
    3. Patients on peritoneal dialysis.
    4. Patients with substantial residual renal output (>300 ml per day).
    5. Patients with pruritus only during the dialysis session (by patient
    report).
    6. Patients with pruritus probably or definitely attributed to a cause
    other than end stage renal disease or its complications (e.g., patients
    with concomitant pruritic dermatological disease or cholestatic liver
    disease will be excluded).
    7. Patients with a serum alanine aminotransferase (ALT) or aspartate
    aminotransferase (AST) greater than 2.5 times the reference upper limit
    of normal (ULN), or total bilirubin greater than 2 times ULN at screening.
    8. Patients with a history of clinically significant drug or alcohol abuse in
    the opinion of the investigator in the last year prior to Baseline (Day 0).
    9. Patients using any topical agents with potential antipruritic activity,
    excluding emollients, during the 2 weeks before the baseline visit.
    10. Patients with systemic antipruritic treatment during the 2 weeks
    before the baseline visit. Second and third generation oral
    antihistamines are allowed if the patient is on stable dose of
    antihistamine and this dose is not changed during the study period. First
    generation oral antihistamines are disallowed.
    11. Patients on immuno-suppressant treatment such as Cyclosporine A
    (CsA), Methotrexate, Glucocorticoid steroids and similar compounds.
    12. Patients who have received ultraviolet B treatment in the 4 weeks
    prior to the start of Screening or anticipated to receive such treatment
    during the study.
    13. Patients who have participated in any other clinical study with an
    investigational medicinal product (IMP) within 3 months before the first
    day of administration of study treatment.
    14. Patients who are pregnant, planning pregnancy, breastfeeding
    and/or are unwilling to use adequate contraception (as specified in
    inclusion criterion 5) during the trial.
    15. Patients, in the opinion of the Investigator, not suitable to
    participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in worst-itching over the last 24 hours on the 11-
    point Numerical Rating Scale (NRS) in DS107 treated population
    compared to placebo at Week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
     Change from baseline in mean itching over the last 24 hours on the 11
    point NRS in DS107 treated population compared to placebo at Week 2,
    4, 6, 8, 10, 12 and 14.
     Change from Week 12 (end of treatment/early termination visit) in
    worst-itching on the 11-point NRS in DS107 treated population
    compared to placebo at Week 14 (follow-up).
     Change from baseline in worst-itching on the 11-point NRS in DS107
    treated population compared to placebo at Week 2, 4, 6, 8, 10 and 14.
     Percentage of patients achieving improvement of pruritus of at least
    2.7 points based on NRS at Week 2, 4, 6, 8, 10, 12 and 14.
     Change from baseline in worst itching on the Dynamic Pruritus Score DPS) in DS107 treated population compared to placebo at Week 2, 4, 6,
    8, 10, 12 and 14.
     Change from baseline in ItchyQoL assessment in DS107 treated
    population compared to placebo population from baseline to Week 2, 4,
    6, 8, 10, 12 and 14.
     Change in sleep quality assessment in DS107 treated population
    compared to placebo population from baseline to Week 2, 4, 6, 8, 10, 12
    and 14.
     Change in xerosis scoring in DS107 treated population compared to
    placebo population from baseline to Week 2, 4, 6, 8, 10, 12 and 14.
     Change from baseline to Week 2, 4, 6, 8, 10, 12 and 14, in worstitching
    on the 11-point NRS in the DS107 treated population compared
    to placebo treated sub-populations of subjects with a normal white blood
    cell count defined by a white blood cell (WBC) count of 3.5 -11.1 x109/L
    and a Neutrophil count of 1.8 -7.0 x109/L
     Change from baseline to Week 2, 4, 6, 8, 10, 12 and 14, in worstitching
    on the 11-point NRS in the DS107 treated population compared
    to placebo treated sub-populations of subjects with a normal eosinophil
    count (< 0.3 x109/L).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 2, 4, 6, 8, 10, 12 and 14
    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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Germany
    Latvia
    Poland
    Ukraine
    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
    Last visit last patient
    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 days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 61
    F.4.2.2In the whole clinical trial 110
    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)
    Standard treatment used as routine for each patient.
    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 Decision2018-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-08-28
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