Oral DS107 in Moderate to Severe Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Oral DS107
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral DS107 2g<br>Oral DS1072g, 4 x 500mg capsules administered orally once a day | Drug: Oral DS107<br> <br> * Other names: DGLA (Dihomo-gamma-linolenic acid) 500 mg gelatin capsule;|
| Placebo Comparator: Placebo<br>Placebo capsules matching Oral DS107 capsules | Drug: Placebo<br> <br> * Other names: Liquid paraffin capsule to mimic Oral DS107 500 mg gelatin capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8. | 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. | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in IGA at Week 2, 4 and 8. | 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. | Baseline, Week 2, Week 4 and Week 8 | 
| Change From Baseline in Eczema Area and Severity Index (EASI) at Week 2, 4 and 8. | 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. | Baseline, Week 2, Week 4 and Week 8 | 
| Proportion of Patients Achieving at Least a 1-point Decrease in IGA at Week 8. | 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. | Up to 8 weeks. | 
| Change From Baseline in the Patient Orientated Eczema Measure (POEM) at Week 2, 4 and 8. | 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. | Baseline, Week 2, Week 4 and Week 8 | 
| Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at Week 2, 4 and 8. | 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. | Baseline, Week 2, Week 4 and Week 8 | 
| Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 2, 4 and 8. | 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. | Baseline, Week 2, Week 4 and Week 8 | 
| Change From Baseline in the Patient's Visual Analog Scale (VAS) Pruritus Score at Week 2, 4 and 8. | 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. | Baseline, Week 2, Week 4 and Week 8 | 
| Change From Baseline in Body Surface Area (BSA) at Week 2, 4 and 8. | 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. | Baseline, Week 2, Week 4 and Week 8 | 
| Number of Participants With TEAEs in Each Treatment Group | Number of participants with at least 1 TEAE. | Up to 14 weeks |