Oral DS107 in Moderate to Severe Atopic Dermatitis

A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS107G to Patients With Moderate to Severe Atopic Dermatitis

This study will compare the safety and efficacy of Oral DS107 (2 g) to placebo in patients with moderate to severe atopic dermatitis.

Oral DS107 (2 g) will be orally administered for 8 weeks, and will be compared against placebo.

This study will enroll approximately 100 adult patients.

Subjects will come to the clinic on 6 occasions: at screening, baseline, week 2, week 4, week 8 (end of treatment/early termination) and week 10 (follow-up). The primary efficacy variable will be the IGA. Secondary efficacy variables will include IGA (Investigator's Global Assessment), SCORAD (Scoring Atopic Dermatitis) Visual Analog Scale (VAS), EASI, BSA (Body Surface Area), POEM (Patient Orientated Eczema Measure), DLQI (Dermatology Life Quality Index).

Inclusion Criteria:

• Male or female subject aged 18 years and older.
• Moderate to severe atopic dermatitis.

Exclusion Criteria:

• Clinically significant impairment of renal or hepatic function.
• History of hypersensitivity to any substance in Oral DS107 or placebo capsules.
• Treatment with any experimental drug within 30 days prior to Day 0 visit (baseline).
• Excessive sun exposure, use of tanning booths or other ultraviolet (UV) light sources and/or is planning a trip to sunny climate.