<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03817190</url>
  </required_header>
  <id_info>
    <org_study_id>DS107G-05-AD3</org_study_id>
    <nct_id>NCT03817190</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis</brief_title>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DS Biopharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DS Biopharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare the efficacy and safety of orally administered&#xD;
      DS107 (2g) versus placebo in the treatment of moderate to severe Atopic Dermatitis (AD).&#xD;
&#xD;
      Oral DS107/Placebo capsules will be administered for 16 weeks. The study will enrol&#xD;
      approximately 220 subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study involves a comparison of 2g DS107 with placebo, administered orally once daily for&#xD;
      a total of 16 weeks. Patients will be randomized to one of the two treatment arms in a 1:1&#xD;
      ratio.&#xD;
&#xD;
      The primary endpoint will be the vIGA (Validated Investigator's Global Assessment) and EASI&#xD;
      (Eczema Area and Severity Index). Other endpoints include vIGA, EASI, SCORAD, BSA (Body&#xD;
      Surface Area) and NRS (Numeric Rating Scale).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Based on Interim Analysis results&#xD;
  </why_stopped>
  <start_date type="Actual">September 19, 2019</start_date>
  <completion_date type="Actual">September 3, 2020</completion_date>
  <primary_completion_date type="Actual">September 3, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Patients Achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis Score of 0 or 1 and a Decrease of at Least 2 Points in vIGA-ADTM in Treated Population Compared to Placebo Population From Baseline at Week 16.</measure>
    <time_frame>16 Weeks</time_frame>
    <description>Proportion of patients achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis (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 using GLMM.The vIGA-ADTM scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Patients Achieving EASI-75 in Treated Population Compared to Placebo Population at Week 16.</measure>
    <time_frame>16 Weeks</time_frame>
    <description>Proportion of patients achieving EASI-75 (≥75% improvement from Baseline) in treated population compared to placebo population at Week 16 using GLMM.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients Achieving a vIGA-ADTM Score of 0 or 1 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.</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12, Week 18 and Week 20.</time_frame>
    <description>Proportion of patients achieving a Validated Investigator Global Assessment for Atopic Dermatitis (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.&#xD;
The vIGA-ADTM scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12, Week 18 and Week 20.</time_frame>
    <description>Proportion of Patients Achieving EASI-75 (≥75% Improvement in Eczema Area and Severity Index from Baseline) in Treated Population Compared to Placebo Population at Weeks 4, 8, 12, 18 and 20 EASI quantifies the severity of a patient's AD based on both lesion severity and the percent of BSA affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) Score in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20.</measure>
    <time_frame>20 Weeks</time_frame>
    <description>The Validated Global Investigator Assessment scale for Atopic Dermatitis (vIGA-AD) scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in Validated Global Investigator Assessment scale indicates a positive outcome for the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EASI in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20.</measure>
    <time_frame>Week 20</time_frame>
    <description>Change from Baseline in Eczema Area and Severity Index (EASI) in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected.&#xD;
The EASI is a composite score ranging from 0 (no lesion severity) to 72 (severe lesions) that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of Body Surface Area (BSA) involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):&#xD;
0 = none&#xD;
1 = mild&#xD;
2 = moderate&#xD;
3 = severe A decrease in EASI indicates a positive outcome for the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Worst Itch NRS in Treated Population Compared to Placebo Population to Week 4, 8, 12, 16, 18.</measure>
    <time_frame>Week 18</time_frame>
    <description>Change from Baseline in worst itch Numeric Rating Scale (NRS) in treated population compared to placebo population to Week 4, 8, 12, 16 and 18. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients will score their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients will complete the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>Week 20</time_frame>
    <description>Proportion of Patients Achieving a Decrease of at Least 3 Points in Worst Itch Numeric Rating Scale (NRS) in Treated Population Compared to Placebo Population From Baseline to Week 4, 8, 12, 16, 18 and 20.&#xD;
The Pruritus NRS is a single-question assessment tool that will be used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients score their pruritus due to AD on a scale of 0 - 10, with 0 (no itch) and 10 (worst itch imaginable). Patients will complete the rating scale daily starting at screening through to the last study visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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,</measure>
    <time_frame>Week 20</time_frame>
    <description>Proportion of patients achieving a decrease of at least 4 points in worst itch Numeric Rating Scale (NRS) in treated population compared to placebo population from baseline to Week 4, 8, 12, 16, 18 and 20. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that is used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients will score their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients completed the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>Week 20</time_frame>
    <description>Proportion of Patients Achieving EASI-50 (≥50% Improvement in Eczema Area and Severity Index From Baseline) in Treated Population Compared to Placebo Population at Week 4, 8, 12, 16, 18 and 20.&#xD;
The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of Body Surface Area (BSA) involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):&#xD;
0 = none&#xD;
1 = mild&#xD;
2 = moderate&#xD;
3 = severe A decrease in EASI indicates a positive outcome for the participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Body Surface Area Affected by AD in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18.</measure>
    <time_frame>Week 18</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18.</measure>
    <time_frame>18 Weeks</time_frame>
    <description>The SCORing Atopic Dermatitis (SCORAD) grading system was developed by the European Task Force on Atopic Dermatitis and has been a standard tool to assess atopic dermatitis (AD) severity in clinical studies. Six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) will be selected to evaluate the AD severity. The intensity of each item is graded using a 4-point scale:&#xD;
0 = No symptoms&#xD;
1 = Mild&#xD;
2 = Moderate&#xD;
3 = Severe The overall body surface area (BSA) affected by AD is evaluated (from 0 to 100%) and included in the SCORAD scores. Loss of sleep and pruritus will be evaluated by patients on a visual analog scale (0-10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).</measure>
    <time_frame>20 Weeks</time_frame>
    <description>Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Safety Analysis Set.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">219</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>2g Oral DS107</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2g DS107 (4 DS107 capsules) administered once-daily for 16 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (4 placebo capsules) orally administered once-daily for 16 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DS107</intervention_name>
    <description>DS107 Capsule</description>
    <arm_group_label>2g Oral DS107</arm_group_label>
    <other_name>DS107 500mg DGLA Capsules/DS107 500mg Placebo Capsules</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo capsule</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with a clinically confirmed diagnosis of active AD according to the American&#xD;
             Academy of Dermatology Consensus Criteria that had been present for at least 6 months&#xD;
             before the screening visit.&#xD;
&#xD;
          2. Patients with moderate to severe AD at baseline as defined by a Validated Investigator&#xD;
             Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) score of 3 Or 4 at baseline.&#xD;
&#xD;
          3. Patients with an Eczema Area and Severity Index (EASI) score of ≥16 at screening and&#xD;
             baseline.&#xD;
&#xD;
          4. Patients with AD covering a minimum 10% of the Body Surface Area (BSA) at baseline.&#xD;
&#xD;
          5. Patients with a worst itch Numeric Rating Scale (NRS) score in a day of ≥4 (on&#xD;
             11-point NRS) at the screening and baseline visits.&#xD;
&#xD;
          6. Patients whose pre-study clinical laboratory findings did not interfere with their&#xD;
             participation in the study, in the opinion of the investigator.&#xD;
&#xD;
          7. Patients who were able and willing to stop all current treatments for AD throughout&#xD;
             the study (except for allowed emollients).&#xD;
&#xD;
          8. Patients who were on a stable dose of a bland emollient for at least 7 days prior to&#xD;
             baseline.&#xD;
&#xD;
          9. Male or female patients aged 18 years and older on the day of signing the informed&#xD;
             consent form (ICF).&#xD;
&#xD;
         10. Female patients and male patients with female partners of child bearing potential had&#xD;
             to use highly effective birth control methods or have a sterilised partner for the&#xD;
             duration of the study.&#xD;
&#xD;
         11. Recent history (within 6 months before the screening visit) of inadequate response to&#xD;
             treatment with topical medications or for whom topical treatments were otherwise&#xD;
             medically inadvisable (e.g. because of important side effects or safety risks).&#xD;
&#xD;
         12. Patients who were able to communicate well with the investigator, to understand and&#xD;
             comply with the requirements of the study, and understand and sign the written&#xD;
             informed consent prior to initiation of any study specific activities or procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with other skin conditions that might interfere with AD diagnosis and/or&#xD;
             evaluation (such as psoriasis or current active viral, bacterial and fungal topical&#xD;
             skin infections) as assessed by the investigator.&#xD;
&#xD;
          2. Patients who had used systemic treatments that could affect AD less than 4 weeks prior&#xD;
             to Baseline Visit (Day 0), e.g. retinoids, methotrexate, cyclosporine,&#xD;
             hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids.&#xD;
&#xD;
             Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions&#xD;
             were allowed.&#xD;
&#xD;
          3. Patients with previous exposure to DS107.&#xD;
&#xD;
          4. Patients who had used any topical medicated treatment for AD (except for emollients)&#xD;
             two weeks prior to start of treatment/Baseline (Day 0) including but not limited to,&#xD;
             topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials and&#xD;
             bleach baths.&#xD;
&#xD;
          5. Patients who used emollients containing urea, ceramides or hyaluronic acid less than&#xD;
             12 weeks prior to Baseline (Day 0).&#xD;
&#xD;
          6. Patients who have had excessive sun exposure, have used tanning booths or other&#xD;
             ultraviolet (UV) light sources four weeks prior to Baseline (Day 0) and/or were&#xD;
             planning a trip to a sunny climate or to use tanning booths or other UV sources&#xD;
             between screening and follow-up visits.&#xD;
&#xD;
          7. Patients who had a history of hypersensitivity to any substance in DS107 or placebo&#xD;
             capsules.&#xD;
&#xD;
          8. Patients who had a history of hypersensitivity to soy beans or soy lecithin.&#xD;
&#xD;
          9. Patients who had a white cell count or differential white cell count outside of the&#xD;
             normal reference range at screening.&#xD;
&#xD;
         10. Patients who had any clinically significant controlled or uncontrolled medical&#xD;
             condition or laboratory abnormality that would, in the opinion of the investigator,&#xD;
             put the patient at undue risk or interfere with interpretation of study results.&#xD;
&#xD;
         11. Patients who had a clinically significant impairment of renal or hepatic function.&#xD;
&#xD;
         12. Patients with significant uncontrolled cardiovascular, neurologic, malignant,&#xD;
             psychiatric, respiratory or hypertensive disease, as well as uncontrolled diabetes and&#xD;
             fluoride arthritis or any other illness that, in the opinion of the investigator, was&#xD;
             likely to interfere with completion of the study.&#xD;
&#xD;
         13. Patients with active infectious diseases (e.g. hepatitis B, hepatitis C or advanced&#xD;
             disease secondary to infection with human immunodeficiency virus).&#xD;
&#xD;
         14. Patients with a history of clinically significant drug or alcohol abuse in the opinion&#xD;
             of the investigator in the last year prior to Baseline (Day 0).&#xD;
&#xD;
         15. Patients who had participated in any other clinical study with an investigational drug&#xD;
             within 3 months before the first day of administration of study treatment.&#xD;
&#xD;
         16. Patients who have had treatment with biologics as follows:&#xD;
&#xD;
             Any cell-depleting agents including but not limited to rituximab: within 6 months&#xD;
             before the screening visit, or until lymphocyte count returned to normal, whichever&#xD;
             was longer. b. Other biologics influencing cell proliferation: within 6 months before&#xD;
             the screening visit. c. Dupilumab or other monoclonal antibodies within 5 half-lives&#xD;
             (if known) or 16 weeks prior to baseline visit, whichever was longer.&#xD;
&#xD;
         17. Patients who were pregnant, planning pregnancy, breastfeeding and/or were unwilling to&#xD;
             use adequate contraception (as specified in Inclusion Criterion 10) during the trial.&#xD;
&#xD;
         18. Patients, in the opinion of the investigator, not suitable to participate in the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Markus Weissbach, MD</last_name>
    <role>Study Chair</role>
    <affiliation>DS Biopharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>DS Investigational Site 524</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 528</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 502</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 504</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 505</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 516</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 501</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 517</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 527</name>
      <address>
        <city>Doral</city>
        <state>Florida</state>
        <zip>33122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 510</name>
      <address>
        <city>Sunrise</city>
        <state>Florida</state>
        <zip>33351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 512</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 514</name>
      <address>
        <city>Skokie</city>
        <state>Illinois</state>
        <zip>60077</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 513</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 519</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 511</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 526</name>
      <address>
        <city>Grants Pass</city>
        <state>Oregon</state>
        <zip>97527</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 521</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 525</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 509</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 506</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 508</name>
      <address>
        <city>Cypress</city>
        <state>Texas</state>
        <zip>77433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 507</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigative Site 529</name>
      <address>
        <city>Orem</city>
        <state>Utah</state>
        <zip>84058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigative Site 530</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 523</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 518</name>
      <address>
        <city>Kenosha</city>
        <state>Wisconsin</state>
        <zip>53144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 101</name>
      <address>
        <city>Graz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 203</name>
      <address>
        <city>Augsburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 202</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 208</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 204</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 206</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 201</name>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 207</name>
      <address>
        <city>Gera</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 211</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 205</name>
      <address>
        <city>Luebeck</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 210</name>
      <address>
        <city>Mainz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 214</name>
      <address>
        <city>Münster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 212</name>
      <address>
        <city>Rostock</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 304</name>
      <address>
        <city>Jūrmala</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 301</name>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 302</name>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 303</name>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 305</name>
      <address>
        <city>Riga</city>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 406</name>
      <address>
        <city>Gdańsk</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 403</name>
      <address>
        <city>Poznań</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 405</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 407</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 401</name>
      <address>
        <city>Wrocław</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DS Investigational Site 402</name>
      <address>
        <city>Łódź</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
    <country>Latvia</country>
    <country>Poland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <results_first_submitted>February 2, 2022</results_first_submitted>
  <results_first_submitted_qc>May 5, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 6, 2022</results_first_posted>
  <last_update_submitted>November 3, 2022</last_update_submitted>
  <last_update_submitted_qc>November 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 18, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03817190/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03817190/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 219 patients were randomised in a 1:1 ratio.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Placebo (4 placebo capsules) orally administered once daily for 16 weeks.</description>
        </group>
        <group group_id="P2">
          <title>DS107 2000mg</title>
          <description>2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="110"/>
                <participants group_id="P2" count="109"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="59"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Early Termination</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigator Decision</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Due to Coronavirus, the patient did not want to continue the study.</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Contact</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Due to worsening of atopic dermatitis and use of Con Med, patient was excluded</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Randomised Set consists of all patients who are randomised to the study.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Placebo (4 placebo capsules) orally administered once daily for 16 weeks.</description>
        </group>
        <group group_id="B2">
          <title>DS107 2000mg</title>
          <description>2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="110"/>
            <count group_id="B2" value="109"/>
            <count group_id="B3" value="219"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.95" spread="14.90"/>
                    <measurement group_id="B2" value="38.83" spread="15.45"/>
                    <measurement group_id="B3" value="38.38" spread="15.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="115"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="87"/>
                    <measurement group_id="B3" value="177"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Surface Area Affected</title>
          <units>Percentage of body surface area</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35.95" spread="17.69"/>
                    <measurement group_id="B2" value="35.67" spread="18.08"/>
                    <measurement group_id="B3" value="35.81" spread="17.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Patients Achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis Score of 0 or 1 and a Decrease of at Least 2 Points in vIGA-ADTM in Treated Population Compared to Placebo Population From Baseline at Week 16.</title>
        <description>Proportion of patients achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis (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 using GLMM.The vIGA-ADTM scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.</description>
        <time_frame>16 Weeks</time_frame>
        <population>Full analysis set - consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (4 placebo capsules) orally administered once daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DS107 2000mg</title>
            <description>2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis Score of 0 or 1 and a Decrease of at Least 2 Points in vIGA-ADTM in Treated Population Compared to Placebo Population From Baseline at Week 16.</title>
          <description>Proportion of patients achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis (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 using GLMM.The vIGA-ADTM scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.</description>
          <population>Full analysis set - consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
          <units>Number of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.6880</p_value>
            <method>GLMM</method>
            <param_type>Proportion of participants</param_type>
            <param_value>-0.2277</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.0415</ci_lower_limit>
            <ci_upper_limit>0.5860</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Proportion of Patients Achieving EASI-75 in Treated Population Compared to Placebo Population at Week 16.</title>
        <description>Proportion of patients achieving EASI-75 (≥75% improvement from Baseline) in treated population compared to placebo population at Week 16 using GLMM.</description>
        <time_frame>16 Weeks</time_frame>
        <population>Full analysis set consists of all patients who were randomised to the study, received at least one dose of study medication and whom reached week 16. Analysis was done according to the treatment patients were randomised to.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (4 placebo capsules) orally administered once daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DS107 2000mg</title>
            <description>2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Achieving EASI-75 in Treated Population Compared to Placebo Population at Week 16.</title>
          <description>Proportion of patients achieving EASI-75 (≥75% improvement from Baseline) in treated population compared to placebo population at Week 16 using GLMM.</description>
          <population>Full analysis set consists of all patients who were randomised to the study, received at least one dose of study medication and whom reached week 16. Analysis was done according to the treatment patients were randomised to.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4321</p_value>
            <method>GLMM</method>
            <param_type>Proportion of participants</param_type>
            <param_value>-0.2760</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9185</ci_lower_limit>
            <ci_upper_limit>0.3665</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients Achieving a vIGA-ADTM Score of 0 or 1 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.</title>
        <description>Proportion of patients achieving a Validated Investigator Global Assessment for Atopic Dermatitis (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.&#xD;
The vIGA-ADTM scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.</description>
        <time_frame>Baseline, Week 4, Week 8, Week 12, Week 18 and Week 20.</time_frame>
        <population>Full analysis set - consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (4 placebo capsules) orally administered once daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DS107 2000mg</title>
            <description>2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Achieving a vIGA-ADTM Score of 0 or 1 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.</title>
          <description>Proportion of patients achieving a Validated Investigator Global Assessment for Atopic Dermatitis (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.&#xD;
The vIGA-ADTM scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.</description>
          <population>Full analysis set - consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="58"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="45"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 to Week 18</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 to Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>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</title>
        <description>Proportion of Patients Achieving EASI-75 (≥75% Improvement in Eczema Area and Severity Index from Baseline) in Treated Population Compared to Placebo Population at Weeks 4, 8, 12, 18 and 20 EASI quantifies the severity of a patient's AD based on both lesion severity and the percent of BSA affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.</description>
        <time_frame>Baseline, Week 4, Week 8, Week 12, Week 18 and Week 20.</time_frame>
        <population>Full analysis set - consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (4 placebo capsules) orally administered once daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DS107 2000mg</title>
            <description>2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>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</title>
          <description>Proportion of Patients Achieving EASI-75 (≥75% Improvement in Eczema Area and Severity Index from Baseline) in Treated Population Compared to Placebo Population at Weeks 4, 8, 12, 18 and 20 EASI quantifies the severity of a patient's AD based on both lesion severity and the percent of BSA affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.</description>
          <population>Full analysis set - consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline to Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline to Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) Score in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20.</title>
        <description>The Validated Global Investigator Assessment scale for Atopic Dermatitis (vIGA-AD) scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in Validated Global Investigator Assessment scale indicates a positive outcome for the participant.</description>
        <time_frame>20 Weeks</time_frame>
        <population>FAS consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (4 placebo capsules) orally administered once daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DS107 2000mg</title>
            <description>2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) Score in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20.</title>
          <description>The Validated Global Investigator Assessment scale for Atopic Dermatitis (vIGA-AD) scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in Validated Global Investigator Assessment scale indicates a positive outcome for the participant.</description>
          <population>FAS consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7843" lower_limit="0.4869" upper_limit="1.0816"/>
                    <measurement group_id="O2" value="-0.0454" lower_limit="-0.4715" upper_limit="0.3807"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3487" lower_limit="0.03437" upper_limit="0.6630"/>
                    <measurement group_id="O2" value="0.2577" lower_limit="-0.1929" upper_limit="0.7083"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1224" lower_limit="-0.2109" upper_limit="0.4558"/>
                    <measurement group_id="O2" value="0.3091" lower_limit="-0.1687" upper_limit="0.7870"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2813" lower_limit="-0.01342" upper_limit="0.5761"/>
                    <measurement group_id="O2" value="0.1394" lower_limit="-0.2781" upper_limit="0.5568"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0862" lower_limit="-0.2366" upper_limit="0.4089"/>
                    <measurement group_id="O2" value="0.1283" lower_limit="-0.3349" upper_limit="0.5914"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18 vs Last Visit ( Week 20)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0689" lower_limit="-0.2153" upper_limit="0.3531"/>
                    <measurement group_id="O2" value="0.1024" lower_limit="-0.3055" upper_limit="0.5102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EASI in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20.</title>
        <description>Change from Baseline in Eczema Area and Severity Index (EASI) in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected.&#xD;
The EASI is a composite score ranging from 0 (no lesion severity) to 72 (severe lesions) that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of Body Surface Area (BSA) involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):&#xD;
0 = none&#xD;
1 = mild&#xD;
2 = moderate&#xD;
3 = severe A decrease in EASI indicates a positive outcome for the participant.</description>
        <time_frame>Week 20</time_frame>
        <population>Full analysis set consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (4 placebo capsules) orally administered once daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DS107 2000mg</title>
            <description>2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in EASI in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20.</title>
          <description>Change from Baseline in Eczema Area and Severity Index (EASI) in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected.&#xD;
The EASI is a composite score ranging from 0 (no lesion severity) to 72 (severe lesions) that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of Body Surface Area (BSA) involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):&#xD;
0 = none&#xD;
1 = mild&#xD;
2 = moderate&#xD;
3 = severe A decrease in EASI indicates a positive outcome for the participant.</description>
          <population>Full analysis set consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 vs Basline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.4509" lower_limit="17.6525" upper_limit="45.2493"/>
                    <measurement group_id="O2" value="3.5453" lower_limit="-16.1397" upper_limit="23.2303"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4747" lower_limit="-0.08487" upper_limit="29.0342"/>
                    <measurement group_id="O2" value="8.8565" lower_limit="-11.9180" upper_limit="29.6310"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4487" lower_limit="-8.9305" upper_limit="21.8279"/>
                    <measurement group_id="O2" value="10.4186" lower_limit="-11.6294" upper_limit="32.4667"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.4269" lower_limit="4.8107" upper_limit="32.0431"/>
                    <measurement group_id="O2" value="3.5470" lower_limit="-15.6720" upper_limit="22.7661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1677" lower_limit="-10.7908" upper_limit="19.1262"/>
                    <measurement group_id="O2" value="3.1252" lower_limit="-18.2311" upper_limit="24.4815"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18 vs Last Visit (Week 20)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6189" lower_limit="-53.4435" upper_limit="58.6812"/>
                    <measurement group_id="O2" value="10.1487" lower_limit="-70.3673" upper_limit="90.6647"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Worst Itch NRS in Treated Population Compared to Placebo Population to Week 4, 8, 12, 16, 18.</title>
        <description>Change from Baseline in worst itch Numeric Rating Scale (NRS) in treated population compared to placebo population to Week 4, 8, 12, 16 and 18. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients will score their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients will complete the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.</description>
        <time_frame>Week 18</time_frame>
        <population>Full analysis set consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (4 placebo capsules) orally administered once daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DS107 2000mg</title>
            <description>2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Worst Itch NRS in Treated Population Compared to Placebo Population to Week 4, 8, 12, 16, 18.</title>
          <description>Change from Baseline in worst itch Numeric Rating Scale (NRS) in treated population compared to placebo population to Week 4, 8, 12, 16 and 18. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients will score their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients will complete the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.</description>
          <population>Full analysis set consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9916" lower_limit="1.1339" upper_limit="2.8493"/>
                    <measurement group_id="O2" value="-0.5094" lower_limit="-1.7037" upper_limit="0.6848"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2897" lower_limit="0.4072" upper_limit="2.1723"/>
                    <measurement group_id="O2" value="-0.2826" lower_limit="-1.5060" upper_limit="0.9408"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8685" lower_limit="-0.05200" upper_limit="1.7889"/>
                    <measurement group_id="O2" value="-0.2133" lower_limit="-1.4913" upper_limit="1.0646"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2244" lower_limit="-0.7377" upper_limit="1.1865"/>
                    <measurement group_id="O2" value="0.0258" lower_limit="-1.3063" upper_limit="1.3579"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0905" lower_limit="-0.9063" upper_limit="1.0873"/>
                    <measurement group_id="O2" value="0.1468" lower_limit="-1.2412" upper_limit="1.5348"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>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.</title>
        <description>Proportion of Patients Achieving a Decrease of at Least 3 Points in Worst Itch Numeric Rating Scale (NRS) in Treated Population Compared to Placebo Population From Baseline to Week 4, 8, 12, 16, 18 and 20.&#xD;
The Pruritus NRS is a single-question assessment tool that will be used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients score their pruritus due to AD on a scale of 0 - 10, with 0 (no itch) and 10 (worst itch imaginable). Patients will complete the rating scale daily starting at screening through to the last study visit.</description>
        <time_frame>Week 20</time_frame>
        <population>Full analysis set consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (4 placebo capsules) orally administered once daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DS107 2000mg</title>
            <description>2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>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.</title>
          <description>Proportion of Patients Achieving a Decrease of at Least 3 Points in Worst Itch Numeric Rating Scale (NRS) in Treated Population Compared to Placebo Population From Baseline to Week 4, 8, 12, 16, 18 and 20.&#xD;
The Pruritus NRS is a single-question assessment tool that will be used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients score their pruritus due to AD on a scale of 0 - 10, with 0 (no itch) and 10 (worst itch imaginable). Patients will complete the rating scale daily starting at screening through to the last study visit.</description>
          <population>Full analysis set consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>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,</title>
        <description>Proportion of patients achieving a decrease of at least 4 points in worst itch Numeric Rating Scale (NRS) in treated population compared to placebo population from baseline to Week 4, 8, 12, 16, 18 and 20. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that is used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients will score their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients completed the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.</description>
        <time_frame>Week 20</time_frame>
        <population>FAS consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (4 placebo capsules) orally administered once daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DS107 2000mg</title>
            <description>2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>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,</title>
          <description>Proportion of patients achieving a decrease of at least 4 points in worst itch Numeric Rating Scale (NRS) in treated population compared to placebo population from baseline to Week 4, 8, 12, 16, 18 and 20. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that is used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients will score their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients completed the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.</description>
          <population>FAS consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>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.</title>
        <description>Proportion of Patients Achieving EASI-50 (≥50% Improvement in Eczema Area and Severity Index From Baseline) in Treated Population Compared to Placebo Population at Week 4, 8, 12, 16, 18 and 20.&#xD;
The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of Body Surface Area (BSA) involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):&#xD;
0 = none&#xD;
1 = mild&#xD;
2 = moderate&#xD;
3 = severe A decrease in EASI indicates a positive outcome for the participant.</description>
        <time_frame>Week 20</time_frame>
        <population>Full analysis set consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (4 placebo capsules) orally administered once daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DS107 2000mg</title>
            <description>2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>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.</title>
          <description>Proportion of Patients Achieving EASI-50 (≥50% Improvement in Eczema Area and Severity Index From Baseline) in Treated Population Compared to Placebo Population at Week 4, 8, 12, 16, 18 and 20.&#xD;
The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of Body Surface Area (BSA) involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):&#xD;
0 = none&#xD;
1 = mild&#xD;
2 = moderate&#xD;
3 = severe A decrease in EASI indicates a positive outcome for the participant.</description>
          <population>Full analysis set consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Body Surface Area Affected by AD in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18.</title>
        <description>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.</description>
        <time_frame>Week 18</time_frame>
        <population>Full analysis set consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (4 placebo capsules) orally administered once daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DS107 2000mg</title>
            <description>2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Body Surface Area Affected by AD in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18.</title>
          <description>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.</description>
          <population>Full analysis set consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
          <units>% Change from Baseline</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5575" lower_limit="5.0467" upper_limit="16.0682"/>
                    <measurement group_id="O2" value="-1.1911" lower_limit="-9.0736" upper_limit="6.6913"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0087" lower_limit="1.1680" upper_limit="12.8495"/>
                    <measurement group_id="O2" value="-0.2839" lower_limit="-8.6398" upper_limit="8.0720"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8296" lower_limit="-1.3215" upper_limit="10.9808"/>
                    <measurement group_id="O2" value="-1.4232" lower_limit="-10.2908" upper_limit="7.4445"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.5413" lower_limit="1.1144" upper_limit="11.9681"/>
                    <measurement group_id="O2" value="0.9244" lower_limit="-6.7736" upper_limit="8.6224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4568" lower_limit="-4.4994" upper_limit="7.4129"/>
                    <measurement group_id="O2" value="1.1470" lower_limit="-7.3990" upper_limit="9.6929"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18.</title>
        <description>The SCORing Atopic Dermatitis (SCORAD) grading system was developed by the European Task Force on Atopic Dermatitis and has been a standard tool to assess atopic dermatitis (AD) severity in clinical studies. Six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) will be selected to evaluate the AD severity. The intensity of each item is graded using a 4-point scale:&#xD;
0 = No symptoms&#xD;
1 = Mild&#xD;
2 = Moderate&#xD;
3 = Severe The overall body surface area (BSA) affected by AD is evaluated (from 0 to 100%) and included in the SCORAD scores. Loss of sleep and pruritus will be evaluated by patients on a visual analog scale (0-10).</description>
        <time_frame>18 Weeks</time_frame>
        <population>Full analysis set consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (4 placebo capsules) orally administered once daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DS107 2000mg</title>
            <description>2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18.</title>
          <description>The SCORing Atopic Dermatitis (SCORAD) grading system was developed by the European Task Force on Atopic Dermatitis and has been a standard tool to assess atopic dermatitis (AD) severity in clinical studies. Six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) will be selected to evaluate the AD severity. The intensity of each item is graded using a 4-point scale:&#xD;
0 = No symptoms&#xD;
1 = Mild&#xD;
2 = Moderate&#xD;
3 = Severe The overall body surface area (BSA) affected by AD is evaluated (from 0 to 100%) and included in the SCORAD scores. Loss of sleep and pruritus will be evaluated by patients on a visual analog scale (0-10).</description>
          <population>Full analysis set consists of all patients who were randomised to the study and received at least one dose of study medication. FAS was the primary analysis population for efficacy endpoints. Analysis was done according to the treatment patients were randomised to.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.7003" lower_limit="8.8854" upper_limit="22.5153"/>
                    <measurement group_id="O2" value="-0.9182" lower_limit="-10.6319" upper_limit="8.7955"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.6334" lower_limit="5.4389" upper_limit="19.8279"/>
                    <measurement group_id="O2" value="-0.0799" lower_limit="-10.3366" upper_limit="10.1769"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0487" lower_limit="-3.5504" upper_limit="11.6478"/>
                    <measurement group_id="O2" value="5.2956" lower_limit="-5.5928" upper_limit="16.1840"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3626" lower_limit="0.6168" upper_limit="14.1084"/>
                    <measurement group_id="O2" value="1.8419" lower_limit="-7.6580" upper_limit="11.3419"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 18 vs Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8556" lower_limit="-5.5327" upper_limit="9.2439"/>
                    <measurement group_id="O2" value="4.3232" lower_limit="-6.2245" upper_limit="14.8709"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).</title>
        <description>Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Safety Analysis Set.</description>
        <time_frame>20 Weeks</time_frame>
        <population>Safety Analysis set consists of all patients who received at least one dose of the medication. SAS was the analysis population for all safety endpoints. Analysis was done according to the actual treatment patients received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (4 placebo capsules) orally administered once daily for 16 weeks.</description>
          </group>
          <group group_id="O2">
            <title>DS107 2000mg</title>
            <description>2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).</title>
          <description>Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Safety Analysis Set.</description>
          <population>Safety Analysis set consists of all patients who received at least one dose of the medication. SAS was the analysis population for all safety endpoints. Analysis was done according to the actual treatment patients received.</population>
          <units>Adverse Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="110"/>
                <count group_id="O2" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs with relationship to study medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs leading to death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs that led to withdrawal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 20 weeks.</time_frame>
      <desc>An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational IMP(s). All Adverse Events (AEs) must be recorded in the CRF, defining relationship to IMP and severity. AEs should also be recorded by the Investigator in the patient file/notes.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Placebo (4 placebo capsules) orally administered once daily for 16 weeks.</description>
        </group>
        <group group_id="E2">
          <title>DS107 2000mg</title>
          <description>2g DS107 (4 DS107 capsules) orally administered once daily for 16 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis Ulcerative</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Coronavirus Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Staphylococcal Skin Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Creatine Phosphokinase Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis Atopic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="57" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Eczema Eyelids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Eye Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Macular Oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Faeces soft</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Functional gastrointestinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Haemorrhoids thrombosed</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Lip swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Sluggishness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Breast abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Herpes virus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Nasal herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Pulpitis dental</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Pyoderma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Superinfection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Heat stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Sunburn</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Tooth injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Joint hyperextension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Hypoesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Emotional distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary tract inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Throat tightness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis Atopic</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Alopecia areata</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Diffuse alopecia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Erythrodermic atopic dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
              <event>
                <sub_title>Solar dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="110"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="109"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The decision to terminate the study prematurely was based on the results from an interim analysis.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>DS Biopharma</organization>
      <phone>+35312933590</phone>
      <email>info@dsbiopharma.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03817190
org study id: DS107G-05-AD3
nct id: NCT03817190
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The objective of this study is to compare the efficacy and safety of orally administered
      DS107 (2g) versus placebo in the treatment of moderate to severe Atopic Dermatitis (AD).

      Oral DS107/Placebo capsules will be administered for 16 weeks. The study will enrol
      approximately 220 subjects.
This study involves a comparison of 2g DS107 with placebo, administered orally once daily for
      a total of 16 weeks. Patients will be randomized to one of the two treatment arms in a 1:1
      ratio.

      The primary endpoint will be the vIGA (Validated Investigator's Global Assessment) and EASI
      (Eczema Area and Severity Index). Other endpoints include vIGA, EASI, SCORAD, BSA (Body
      Surface Area) and NRS (Numeric Rating Scale).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Proportion of Patients Achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis Score of 0 or 1 and a Decrease of at Least 2 Points in vIGA-ADTM in Treated Population Compared to Placebo Population From Baseline at Week 16.
time frame: 16 Weeks
description: Proportion of patients achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis (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 using GLMM.The vIGA-ADTM scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.
measure: Proportion of Patients Achieving EASI-75 in Treated Population Compared to Placebo Population at Week 16.
time frame: 16 Weeks
description: Proportion of patients achieving EASI-75 (≥75% improvement from Baseline) in treated population compared to placebo population at Week 16 using GLMM.
measure: Proportion of Patients Achieving a vIGA-ADTM Score of 0 or 1 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.
time frame: Baseline, Week 4, Week 8, Week 12, Week 18 and Week 20.
description: Proportion of patients achieving a Validated Investigator Global Assessment for Atopic Dermatitis (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.
The vIGA-ADTM scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.
measure: 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
time frame: Baseline, Week 4, Week 8, Week 12, Week 18 and Week 20.
description: Proportion of Patients Achieving EASI-75 (≥75% Improvement in Eczema Area and Severity Index from Baseline) in Treated Population Compared to Placebo Population at Weeks 4, 8, 12, 18 and 20 EASI quantifies the severity of a patient's AD based on both lesion severity and the percent of BSA affected. The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.
measure: Change From Baseline in Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) Score in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20.
time frame: 20 Weeks
description: The Validated Global Investigator Assessment scale for Atopic Dermatitis (vIGA-AD) scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in Validated Global Investigator Assessment scale indicates a positive outcome for the participant.
measure: Change From Baseline in EASI in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18 and 20.
time frame: Week 20
description: Change from Baseline in Eczema Area and Severity Index (EASI) in treated population compared to placebo population to Weeks 4, 8, 12, 16, 18 and 20. EASI quantifies the severity of a patient's atopic dermatitis (AD) based on both lesion severity and the percent of body surface area (BSA) affected.
The EASI is a composite score ranging from 0 (no lesion severity) to 72 (severe lesions) that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of Body Surface Area (BSA) involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):
0 = none
1 = mild
2 = moderate
3 = severe A decrease in EASI indicates a positive outcome for the participant.
measure: Change From Baseline in Worst Itch NRS in Treated Population Compared to Placebo Population to Week 4, 8, 12, 16, 18.
time frame: Week 18
description: Change from Baseline in worst itch Numeric Rating Scale (NRS) in treated population compared to placebo population to Week 4, 8, 12, 16 and 18. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that was used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients will score their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients will complete the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.
measure: 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.
time frame: Week 20
description: Proportion of Patients Achieving a Decrease of at Least 3 Points in Worst Itch Numeric Rating Scale (NRS) in Treated Population Compared to Placebo Population From Baseline to Week 4, 8, 12, 16, 18 and 20.
The Pruritus NRS is a single-question assessment tool that will be used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients score their pruritus due to AD on a scale of 0 - 10, with 0 (no itch) and 10 (worst itch imaginable). Patients will complete the rating scale daily starting at screening through to the last study visit.
measure: 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,
time frame: Week 20
description: Proportion of patients achieving a decrease of at least 4 points in worst itch Numeric Rating Scale (NRS) in treated population compared to placebo population from baseline to Week 4, 8, 12, 16, 18 and 20. Severity of pruritus related to atopic dermatitis (AD) was self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that is used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients will score their pruritus due to AD on a scale of 0 - 10, with 0 indicating no itch and 10 indicating the worst itch imaginable. Patients completed the rating scale daily starting at screening through to the last study visit. A decrease in worst itch NRS indicates a positive outcome for the participant.
measure: 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.
time frame: Week 20
description: Proportion of Patients Achieving EASI-50 (≥50% Improvement in Eczema Area and Severity Index From Baseline) in Treated Population Compared to Placebo Population at Week 4, 8, 12, 16, 18 and 20.
The EASI is a composite score ranging from 0-72 that takes into account the degree of erythema, induration/papulation, excoriation, and lichenification (each scored from 0 to 3 separately, half points are permitted) for each of four body regions, with adjustment for the percent of Body Surface Area (BSA) involved for each body region and for the proportion of the body region to the whole body. The severity of each sign is assessed using a 4-point scale (half points are permitted):
0 = none
1 = mild
2 = moderate
3 = severe A decrease in EASI indicates a positive outcome for the participant.
measure: Change From Baseline in the Body Surface Area Affected by AD in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18.
time frame: Week 18
description: 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.
measure: Change From Baseline in the SCORing Atopic Dermatitis (SCORAD) Score in Treated Population Compared to Placebo Population to Weeks 4, 8, 12, 16, 18.
time frame: 18 Weeks
description: The SCORing Atopic Dermatitis (SCORAD) grading system was developed by the European Task Force on Atopic Dermatitis and has been a standard tool to assess atopic dermatitis (AD) severity in clinical studies. Six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) will be selected to evaluate the AD severity. The intensity of each item is graded using a 4-point scale:
0 = No symptoms
1 = Mild
2 = Moderate
3 = Severe The overall body surface area (BSA) affected by AD is evaluated (from 0 to 100%) and included in the SCORAD scores. Loss of sleep and pruritus will be evaluated by patients on a visual analog scale (0-10).
measure: Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
time frame: 20 Weeks
description: Incidence of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Safety Analysis Set.
arm group label: 2g Oral DS107
arm group type: Experimental
description: 2g DS107 (4 DS107 capsules) administered once-daily for 16 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo (4 placebo capsules) orally administered once-daily for 16 weeks
intervention type: Drug
intervention name: DS107
description: DS107 Capsule
arm group label: 2g Oral DS107
other name: DS107 500mg DGLA Capsules/DS107 500mg Placebo Capsules
intervention type: Drug
intervention name: Placebo
description: Placebo capsule
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Markus Weissbach, MD
role: Study Chair
affiliation: DS Biopharma
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country: Austria
country: Germany
country: Latvia
country: Poland
country: United States
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The decision to terminate the study prematurely was based on the results from an interim analysis.
point of contact: 