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    Summary
    EudraCT Number:2019-000932-25
    Sponsor's Protocol Code Number:DS107G-05-AD3
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-07-05
    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 ConcernedAustria - BASG
    A.2EudraCT number2019-000932-25
    A.3Full title of the trial
    A Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Orally Administered DS107 in Adult Patients with Moderate to Severe Atopic Dermatitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Assess the Efficacy and Safety of Orally Administered DS107 in Adult Patients with Moderate to Severe Atopic Dermatitis
    A.4.1Sponsor's protocol code numberDS107G-05-AD3
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03817190
    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 Ltd.
    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 Ltd.
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDS Biopharma Ltd.
    B.5.2Functional name of contact pointRegulatory Affairs Department
    B.5.3 Address:
    B.5.3.1Street AddressTrintech Building, South County Business Park
    B.5.3.2Town/ cityLeopardstown, Dublin
    B.5.3.3Post code18
    B.5.3.4CountryIreland
    B.5.4Telephone number0035312946383
    B.5.5Fax number0035312176117
    B.5.6E-maildsbiopharmaregulatory@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 nameDS107 Capsule
    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.3.9.1CAS number 1783-84-2
    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, soft
    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 Atopic Dermatitis
    E.1.1.1Medical condition in easily understood language
    Moderate to Severe Atopic Dermatitis
    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 21.1
    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
    Efficacy Objective:
    - To compare the efficacy of orally administered DS107 (2g) versus placebo, in the treatment of adult patients with moderate to severe AD.
    Safety Objective:
    - To assess the safety of orally administered DS107 (2g) versus placebo, in adult patients with moderate to severe AD.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with a clinically confirmed diagnosis of active AD according to the American Academy of Dermatology Consensus Criteria that has been present for at least 6 months before the screening visit.
    2. Patients with moderate to severe AD at baseline as defined by a vIGA-ADTM score of 3 or 4 at baseline.
    3. Patients with an EASI score of ≥16 at screening and baseline.
    4. Patients with AD covering a minimum 10% of the body surface area (BSA) at baseline.
    5. Patients with a worst itch NRS score in a day of ≥4 (on 11 point NRS) at the screening and baseline visits.
    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 and willing to stop all current treatments for AD throughout the study (except for allowed emollients).
    8. Patients who are on a stable dose of a bland emollient for at least 7 days prior to baseline.
    Note:
    Patients who have been on a stable emollient with an active ingredient (for example urea, ceramide and hyaluronic acid) for at least 12 weeks prior to screening and are otherwise eligible may continue using their pre-existing emollients, if deemed appropriate by the investigator and if they are willing and able to continue using the same stable emollient for the duration of the study.
    9. Male or female patients aged 18 years and older on the day of signing the informed consent form (ICF).
    10. Female patients and male patients with female partners of child bearing potential must use highly effective birth control methods or have a sterilised partner for the duration of the study.
    Note:
    - Highly effective birth control methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include systemic hormonal contraceptives, intrauterine device or sexual abstinence.
    - Hormonal contraceptives must be on a stable dose for at least one month before baseline.
    - Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
    11. Recent history (within 6 months before the screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).
    Note:
    - Inadequate response is defined as failure to achieve and maintain remission or a low disease activity state (comparable to vIGA-ADTM 0=clear to 2=mild) despite treatment with a daily regimen of Topical corticosteroids (TCS) of medium to higher potency (± Topical calcineurin inhibitors (TCI) as appropriate), applied for at least 28 days or for the maximum duration recommended by the product prescribing information (e.g., 14 days for super-potent TCS), whichever is shorter.
    - Patients with documented systemic treatment for AD (for example systemic corticosteroids, cyclosporin) in the past 6 months are also considered as inadequate responders to topical treatments and are potentially eligible for treatment with DS107 after appropriate washout.
    - Important side effects or safety risks are those that outweigh the potential treatment benefits and include intolerance to treatment, hypersensitivity reactions, significant skin atrophy, and systemic effects, as assessed by the Investigator or by the patient’s treating physician.
    12. 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 prior to initiation of any study specific activities or procedures.
    E.4Principal exclusion criteria
    1. Patients with other skin conditions that might interfere with AD diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and fungal skin infections) as assessed by the Investigator.
    2. Patients who have used systemic treatments that could affect AD less than 4 weeks prior to baseline visit (Day 0), e.g. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids. Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions are allowed.
    3. Patient with previous exposure to DS107.
    4. Patients who have used any topical medicated treatment for AD (except for emollients) two weeks prior to start of treatment/ Baseline (Day 0), including but not limited to, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials and bleach baths.
    5. Patients who use emollients containing urea, ceramides or hyaluronic acid less than 12 weeks prior to Baseline (Day 0).
    6. Patients who have had excessive sun exposure, have used tanning booths or other ultraviolet (UV) light sources four weeks prior to Baseline (Day 0) and/or are planning a trip to a sunny climate or to use tanning booths or other UV sources between screening and follow-up visits.
    7. Patients who have a history of hypersensitivity to any substance in DS107 capsules or placebo capsules.
    8. Patients who have a history of hypersensitivity to soy beans or soy lecithin.
    9. Patients who have a white cell count or differential white cell count outside of the normal reference range at screening.
    Note:
    For patients with a mild leucocytosis or leucopenia and otherwise a normal white cell blood count may be enrolled following consultation with the medical monitor by the investigator.
    10. Patients who have any clinically significant controlled or uncontrolled medical condition or laboratory abnormality that would, in the opinion of the Investigator, put the patient at undue risk or interfere with interpretation of study results.
    11. Patients who have a clinically significant impairment of renal or hepatic function.
    12. Patients with significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease, as well as uncontrolled diabetes and floride arthritis or any other illness that, in the opinion of the Investigator, is likely to interfere with completion of the study.
    13. Patients with active infectious disease (e.g., hepatitis B, hepatitis C or advanced disease secondary to infection with human immunodeficiency virus).
    14. 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).
    15. Patients who have participated in any other clinical study with an investigational drug within 3 months before the first day of administration of study treatment.
    16. Patients who have had treatment with biologics as follows:
    a. Any cell-depleting agents including but not limited to rituximab: within 6 months before the screening visit, or until lymphocyte count returns to normal, whichever is longer,
    b. Other biologics influencing cell proliferation: within 6 months before the screening visit.
    c. Dupilumab or other monoclonal antibodies within 5 half-lives (if known) or 16 weeks prior to baseline visit, whichever is longer
    17. Patients who are pregnant, planning pregnancy, breastfeeding and/or are unwilling to use adequate contraception (as specified in Inclusion Criterion 10) during the trial.
    18. Patients, in the opinion of the Investigator, not suitable to participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    - Proportion of patients achieving a vIGA-ADTM score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in vIGA-ADTM in treated population compared to placebo population from baseline at Week 16.
    - Proportion of patients achieving EASI-75 (≥75% improvement from baseline) in treated population compared to placebo population at Week 16.

    Note: Each of the independent primary endpoints will be assessed separately. Success in either of the primary endpoints denotes treatment success.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline at Week 16.
    E.5.2Secondary end point(s)
    - Proportion of patients achieving a vIGA-ADTM score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in vIGA-ADTM in treated population compared to placebo population from baseline to Week 4, 8, 12, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.
    - Proportion of patients achieving EASI-75 (≥75% improvement from baseline) in treated population compared to placebo population at Weeks 4, 8, 12, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.
    - Change from baseline in vIGA-ADTM score in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.
    - Change from baseline in EASI in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.
    - Proportion of patients achieving a decrease of at least 4 points in worst itch NRS in treated population compared to placebo population from baseline to Week 4, 8, 12, 16, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.
    - Proportion of patients achieving a decrease of at least 3 points in worst itch NRS in treated population compared to placebo population from baseline to Week 4, 8, 12, 16, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.
    - Change from baseline in worst itch NRS in treated population compared to placebo population to Week 4, 8, 12, 16, 18 and 20 and from Week 16 to Week 18 and 20.
    - Proportion of patients achieving EASI-50 (≥50% improvement from baseline) in treated population compared to placebo population at Week 4, 8, 12, 16, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.
    - Change from baseline in the Body Surface Area (BSA) affected by AD in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.
    - Change from baseline in the SCORing Atopic Dermatitis (SCORAD) score in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.
    - Incidence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).

    Exploratory Endpoints
    - Proportion of patients achieving a decrease of at least 2 points in vIGA-ADTM in treated population compared to placebo population from baseline to Week 4, 8, 12, 16, 18 and 20 and the change in proportion of patients from Week 16 to Week 18 and 20.
    - Change from baseline in the Dermatology Life Quality Index (DLQI) score in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.
    - Change from baseline in the Patient Orientated Eczema Measure (POEM) score in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.
    - Change in sleep quality assessment (Athens Insomnia Scale) in treated population compared to placebo population from baseline to Week 4, 8, 12, 16, 18 and 20 and from Week 16 to Week 18 and 20.
    - Change from baseline in the Patient-Oriented SCORAD (PO-SCORAD) score in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20, and from Week 16 to Week 18 and 20.
    - Trough plasma levels in treated population compared to placebo population at Baseline/Day 0, Week 4, Week 8 and Week 16.
    - Determination of AD biomarkers in treated population compared to placebo population at Baseline/Day 0 and Week 16.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, Week 4, 8, 12, 16, 18, 20
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Australia
    Austria
    Germany
    Latvia
    Poland
    United States
    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
    End of Trial is defined as Last Subject Last Visit (LSLV). LSLV is defined as the date the Investigator reviews the last subject’s safety data and determines that no further evaluation is required for the subject to complete the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days12
    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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 220
    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)
    Not different from expected normal treatment.
    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 Decision2019-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-03
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-09-03
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