Efficacy and Safety Study of Orally Administered DS107 in Moderate to Severe Atopic Dermatitis Patients
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: DS107; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 321.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether orally administered DS107 (1g and 2g doses)
      is effective in the treatment of moderate to severe atopic dermatitis.

      Oral DS107 capsules will be administered for 8 weeks and will be compared against placebo.

      The study will enroll approximately 300 subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a clinically confirmed diagnosis of active Atopic Dermatitis according
             to Hanafin and Rajka criteria

          -  Subjects with moderate to severe Atopic Dermatitis at baseline as defined by an IGA of
             minimum 3 at baseline

          -  Subjects with Atopic Dermatitis covering a minimum 10% of the body surface area at
             baseline

          -  Male or female subjects who are aged 18 years and older on the day of signing the
             informed consent form (ICF)

        Exclusion Criteria:

          -  Subjects with other skin conditions that might interfere with Atopic Dermatitis
             diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and
             fungal skin infections) as assessed by the Investigator

          -  Subjects who have used systemic treatments (other than biologics) that could affect
             Atopic Dermatitis less than 4 weeks prior to baseline visit (Day 0), e.g. retinoids,
             methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and
             oral/injectable corticosteroids. Intranasal corticosteroids and inhaled
             corticosteroids for stable medical conditions are allowed

          -  Subjects who have used any topical medicated treatment for Atopic Dermatitis two weeks
             prior to start of treatment/Baseline (Day 0), including but not limited to, topical
             corticosteroids, tars and bleach

          -  Subjects who use topical products containing urea, ceramides or hyaluronic acid two
             weeks prior to Baseline

          -  Subjects who have a history of hypersensitivity to any substance in Oral DS107 or
             placebo capsules

          -  Subjects who have any clinically significant controlled or uncontrolled medical
             condition or laboratory abnormality that would, in the opinion of the investigator,
             put the subject at undue risk or interfere with the interpretation of study results

          -  Subjects with significant uncontrolled cardiovascular, neurologic, malignant,
             psychiatric, respiratory or hypertensive disease, as well as diabetes and arthritis or
             any other illness that, in the opinion of the investigator, is likely to interfere
             with completion of the study

          -  Subjects with chronic infectious disease (e.g. hepatitis B, hepatitis C or infection
             with human immunodeficiency virus)