Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: DS107; Placebo
Intervention description: DS107 Capsule; Placebo capsule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 219.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with a clinically confirmed diagnosis of active AD according to the American
             Academy of Dermatology Consensus Criteria that had been present for at least 6 months
             before the screening visit.

          2. Patients with moderate to severe AD at baseline as defined by a Validated Investigator
             Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) score of 3 Or 4 at baseline.

          3. Patients with an Eczema Area and Severity Index (EASI) score of ≥16 at screening and
             baseline.

          4. Patients with AD covering a minimum 10% of the Body Surface Area (BSA) at baseline.

          5. Patients with a worst itch Numeric Rating Scale (NRS) score in a day of ≥4 (on
             11-point NRS) at the screening and baseline visits.

          6. Patients whose pre-study clinical laboratory findings did not interfere with their
             participation in the study, in the opinion of the investigator.

          7. Patients who were able and willing to stop all current treatments for AD throughout
             the study (except for allowed emollients).

          8. Patients who were on a stable dose of a bland emollient for at least 7 days prior to
             baseline.

          9. Male or female patients aged 18 years and older on the day of signing the informed
             consent form (ICF).

         10. Female patients and male patients with female partners of child bearing potential had
             to use highly effective birth control methods or have a sterilised partner for the
             duration of the study.

         11. Recent history (within 6 months before the screening visit) of inadequate response to
             treatment with topical medications or for whom topical treatments were otherwise
             medically inadvisable (e.g. because of important side effects or safety risks).

         12. Patients who were able to communicate well with the investigator, to understand and
             comply with the requirements of the study, and understand and sign the written
             informed consent prior to initiation of any study specific activities or procedures.

        Exclusion Criteria:

          1. Patients with other skin conditions that might interfere with AD diagnosis and/or
             evaluation (such as psoriasis or current active viral, bacterial and fungal topical
             skin infections) as assessed by the investigator.

          2. Patients who had used systemic treatments that could affect AD less than 4 weeks prior
             to Baseline Visit (Day 0), e.g. retinoids, methotrexate, cyclosporine,
             hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids.

             Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions
             were allowed.

          3. Patients with previous exposure to DS107.

          4. Patients who had used any topical medicated treatment for AD (except for emollients)
             two weeks prior to start of treatment/Baseline (Day 0) including but not limited to,
             topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials and
             bleach baths.

          5. Patients who used emollients containing urea, ceramides or hyaluronic acid less than
             12 weeks prior to Baseline (Day 0).

          6. Patients who have had excessive sun exposure, have used tanning booths or other
             ultraviolet (UV) light sources four weeks prior to Baseline (Day 0) and/or were
             planning a trip to a sunny climate or to use tanning booths or other UV sources
             between screening and follow-up visits.

          7. Patients who had a history of hypersensitivity to any substance in DS107 or placebo
             capsules.

          8. Patients who had a history of hypersensitivity to soy beans or soy lecithin.

          9. Patients who had a white cell count or differential white cell count outside of the
             normal reference range at screening.

         10. Patients who had any clinically significant controlled or uncontrolled medical
             condition or laboratory abnormality that would, in the opinion of the investigator,
             put the patient at undue risk or interfere with interpretation of study results.

         11. Patients who had a clinically significant impairment of renal or hepatic function.

         12. Patients with significant uncontrolled cardiovascular, neurologic, malignant,
             psychiatric, respiratory or hypertensive disease, as well as uncontrolled diabetes and
             fluoride arthritis or any other illness that, in the opinion of the investigator, was
             likely to interfere with completion of the study.

         13. Patients with active infectious diseases (e.g. hepatitis B, hepatitis C or advanced
             disease secondary to infection with human immunodeficiency virus).

         14. Patients with a history of clinically significant drug or alcohol abuse in the opinion
             of the investigator in the last year prior to Baseline (Day 0).

         15. Patients who had participated in any other clinical study with an investigational drug
             within 3 months before the first day of administration of study treatment.

         16. Patients who have had treatment with biologics as follows:

             Any cell-depleting agents including but not limited to rituximab: within 6 months
             before the screening visit, or until lymphocyte count returned to normal, whichever
             was longer. b. Other biologics influencing cell proliferation: within 6 months before
             the screening visit. c. Dupilumab or other monoclonal antibodies within 5 half-lives
             (if known) or 16 weeks prior to baseline visit, whichever was longer.

         17. Patients who were pregnant, planning pregnancy, breastfeeding and/or were unwilling to
             use adequate contraception (as specified in Inclusion Criterion 10) during the trial.

         18. Patients, in the opinion of the investigator, not suitable to participate in the
             study.