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    Summary
    EudraCT Number:2015-002838-46
    Sponsor's Protocol Code Number:DS107E-05
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-07-09
    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 ConcernedIreland - HPRA
    A.2EudraCT number2015-002838-46
    A.3Full title of the trial
    A prospective, randomised, vehicle-controlled, double-blind, exploratory clinical trial to assess the efficacy and steroid sparing potential of DGLA cream topically applied to early childhood patients with moderate to severe atopic dermatitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of DGLA Cream in early childhood patients with atopic dermatitis - inflammatory skin disease.
    A.4.1Sponsor's protocol code numberDS107E-05
    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 pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street AddressTrintech Building, South County Business Park, Leopardstown
    B.5.3.2Town/ cityDublin
    B.5.3.3Post code18
    B.5.3.4CountryIreland
    B.5.4Telephone number+353012998381
    B.5.5Fax number+353012176117
    B.5.6E-mailinfo@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 name1% DGLA Cream
    D.3.2Product code DS107E
    D.3.4Pharmaceutical form Cream
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDGLA
    D.3.9.1CAS number 1783-84-2
    D.3.9.2Current sponsor codeDS107
    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 % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboCream
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    atopic dermatitis
    E.1.1.1Medical condition in easily understood language
    atopic dermatitis – chronic inflammatory skin disease
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10003639
    E.1.2Term Atopic dermatitis
    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 evaluate the clinical efficacy of alternating treatment with Locoid® Ointment (hydrocortisone butyrate 0.1%) and 1% topical DGLA formulation OD compared to Locoid® Ointment (hydrocortisone butyrate 0.1%) and vehicle OD for 1 week, followed by 8 weeks of treatment with either 1% topical DGLA formulation alone BD or vehicle alone BD in early childhood patients with moderate to severe atopic dermatitis.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of DGLA cream in the improvement of clinical signs and symptoms in AD, IGA, SCORAD, EASI, BSA, improvement of quality of life, family impact, investigation of skin barrier function, days to relapse and rescue medication use.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female and male infants aged 3-12 months.
    2. Diagnosis of atopic dermatitis according to the Hanifin and Raika Criteria.
    3. Patients with moderate to severe atopic dermatitis (IGA ≥3)
    4. Patients with atopic dermatitis covering a minimum of 10% of the body surface area at baseline.
    5. Atopic Dermatitis is stable for the past 7 days, in the opinion of the investigator.
    6. The patient's parents are able to apply the study product twice a day (each morning and evening) for a consecutive period of 63 days.
    E.4Principal exclusion criteria
    1. Any clinically significant controlled or uncontrolled medical condition that would, in the opinion of the investigator, put the patient at undue risk or interfere with interpretation of study results.
    2. Clinically significant impairment of renal or hepatic function.
    3. Clinically significant immunodeficiency.
    4. Use of systemic antibiotics less than 2 weeks prior to Baseline Visit (Day 0).
    5. Other skin conditions that might interfere with atopic dermatitis diagnosis and/or evaluation (such as psoriasis or current viral, bacterial and fungal skin infections).
    6. History of intolerance to any ingredient in DS107E DGLA cream or Vehicle or intolerance to any ingredient in Locoid® Ointment (hydrocortisone butyrate 0.1%).
    7. Use of systemic treatments that could affect atopic dermatitis less than 4 weeks prior to Baseline Visit (Day 0), e.g. oral corticosteroids; Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions are allowed.
    8. Treatment with any experimental drug within 30 days prior to Day 0 Visit (Baseline), or 5 half-lives (whichever is longer).
    9. Excessive sun exposure or other ultraviolet (UV) light sources 4 weeks prior to Day 0 Visit (Baseline) and/or is planning a trip to sunny climate or other UV sources between screening and follow-up visits.
    10. Use of any topical medicated treatment for atopic dermatitis 2 weeks prior to start of treatment/Day 0 Visit (Baseline), including but not limited to emollients, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials and bleach baths.
    11. Use of topical products containing ceramides 2 weeks prior to Day 0.
    12. Medical history of chronic infectious disease (e.g., hepatitis B, hepatitis C or infection with human immunodeficiency virus).
    E.5 End points
    E.5.1Primary end point(s)
    Change in IGA from Baseline/Day 0 (Visit 2) to Day 63 (Visit 8).
    And/Or
    Change in SCORAD from Baseline/Day 0 (Visit 2) to Day 63 (Visit 8).
    E.5.1.1Timepoint(s) of evaluation of this end point
    IGA – Screening, Baseline/Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 91 and SCORAD - Screening, Baseline/Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 91
    E.5.2Secondary end point(s)
    • Change in Investigators Global Assessment score (IGA) from Baseline/Day 0 (Visit 2) to Day 7 (Visit 3), Day 21 (Visit 5), Day 35 (Visit 6), Day 49 (Visit 7), Day 63 (Visit 8) and from Day 63 (Visit 8) to Follow up Day 91 (Visit 9).
    • Change in SCORAD from Baseline/Day 0 (Visit 2) to Day 7 (Visit 3), Day 21 (Visit 5), Day 35 (Visit 6), Day 49 (Visit 7), Day 63 (Visit 8) and from Day 63 (Visit 8) to Follow up Day 91 (Visit 9).
    • Change in EASI from Baseline/Day 0 (Visit 2) to Day 7 (Visit 3), Day 21 (Visit 5), Day 35 (Visit 6), Day 49 (Visit 7), Day 63 (Visit 8) and from Day 63 (Visit 8) to Follow up Day 91 (Visit 9).
    • Change in IDQOL from Baseline/Day 0 (Visit 2) to Day 7 (Visit 3), Day 21 (Visit 5), Day 35 (Visit 6), Day 49 (Visit 7), Day 63 (Visit 8) and from Day 63 (Visit 8) to Follow up Day 91 (Visit 9).
    • Change in DFI from Baseline/Day 0 (Visit 2) to Day 7 (Visit 3), Day 21 (Visit 5), Day 35 (Visit 6), Day 49 (Visit 7), Day 63 (Visit 8) and from Day 63 (Visit 8) to Follow up Day 91 (Visit 9).
    • Change in BSA from Baseline/Day 0 (Visit 2) to Day 7 (Visit 3), Day 21 (Visit 5), Day 35 (Visit 6), Day 49 (Visit 7), Day 63 (Visit 8) and from Day 63 (Visit 8) to Follow up Day 91 (Visit 9).
    • Change in the Transepidermal water loss (TEWL) from Baseline/Day 0 (Visit 2) to Day 63 (Visit 8) and from Day 63 (Visit 8) to Follow up Day 91 (Visit 9).
    • Time to rescue medication use: The time elapsed between day 7 and the necessity to use rescue medication before the end of the trial (conditional endpoint).
    E.5.2.1Timepoint(s) of evaluation of this end point
    IGA – Screening, Baseline/Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 91
    SCORAD - Screening, Baseline/Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 91
    EASI - Screening, Baseline/Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 91
    IDQOL - Screening, Baseline/Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 91
    DFI - Screening, Baseline/Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 91
    BSA - Screening, Baseline/Day 0, Day 7, Day 21, Day 35, Day 49, Day 63 and Day 91
    TEWL – Baseline/Day 0, Day 63, Day 91
    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 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
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 40
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 40
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Paediatric infants ages 3 months to 12 months will be included in the trial. The patient’s parents/guardians will sign a written parent/guardian information sheet (PIS) and sign and date a parent/guardian written informed consent form (ICF).
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    Following individual completion of the study, patients will either return to the standard treatment received prior to study participation or to an alternative treatment regimen at the discretion of the investigator.
    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 Decision2015-09-03
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-10-04
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