Oral DS107 in Moderate to Severe Atopic Dermatitis

The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.

The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.

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. The severity of each sign is assessed using a 4-point scale (half points are permitted): 0 = no symptoms 1 = slight 2 = moderate 3 = marked A decrease in EASI score indicates a positive outcome for the participant.

The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.

The Patient-Oriented Eczema Measure (POEM) is a self-assessment of disease severity by the patient. POEM has a maximum value of twenty-eight based on the patient's response to seven questions scored according to the following scale: No Days = 0 1-2 Days = 1 3-4 Days = 2 5-6 Days = 3 Everyday = 4 POEM scale ranges from 0 to 28. 0 to 2 = clear or almost clear. 3 to 7 = mild eczema. 8 to 16 = moderate eczema. 17 to 24 = severe eczema. 25 to 28 = very severe eczema. Lower scores on the scale represent a better outcome for the patient.

The DLQI is a simple 10-question validated questionnaire measuring the impact of a patients skin problem over a 1 week period, which was completed at each visit, except screening. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.

The SCORAD grading system was developed by the European Task Force on Atopic Dermatitis and has been a standard tool to assess the AD severity in clinical studies. Six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) was 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 BSA affected by AD was evaluated (from 0 to 100%) and included in the SCORAD scores. Loss of sleep and pruritus were evaluated by patients on a visual analog scale (0-10). The sum of these measures represents the SCORAD which can vary from 0 to 103. A decrease in SCORAD indicates a positive outcome for the participant.

The pruritus severity score was recorded with the SCORAD measurement and was evaluated as a separate endpoint. This was evaluated by asking subjects to indicate on the 10-cm scale (0-10) of the assessment form the point corresponding to the average value for the last three days/nights. A lower score represents a better outcome for the patient.

One patient's palm represents 1% of his/her total BSA. For all study visits except at screening, the BSA of involved skin will be measured with the SCORAD measurement and evaluated as a separate endpoint.

Number of participants with at least 1 TEAE.