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.
The study will consist of 3 treatment arms, each consisting of approximately 100 subjects. Treatment Arm 1 will receive 1g Oral DS107 daily. Treatment Arm 2 will receive 2g Oral DS107 daily. Treatment Arm 3 will receive placebo daily. The primary objective of the study is to assess the efficacy and safety of daily 1g and 2g doses of Oral DS107 versus placebo. Subjects will come to the clinic on 7 occasions: Screening, Baseline, Week 2, Week 4, Week 6, Week 8 (end of treatment/early termination) and Week 10 (follow-up). The primary efficacy variable will be the IGA (Investigator's Global Assessment). Secondary efficacy variables will include IGA, EASI (Eczema Area and Severity Index), and NRS (Numeric Rating Scale),
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
321
DS Biopharma Site
Philadelphia, Pennsylvania, United States
DS Biopharma Site
Cape Town, South Africa
Proportion of Patients Achieving an Investigators Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population at Week 8.
Proportion of patients achieving an IGA of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA in treated population compared to placebo population at Week 8. The IGA scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.
Time frame: 8 weeks
Proportion of Patients Achieving an IGA Score of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, and 10.
Proportion of patients achieving an IGA score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA in treated population compared to placebo population from Baseline to Weeks 2, 4, 6, and 10. The IGA scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.
Time frame: Baseline, Week 2, Week 4, Week 6 and Week 10
Proportion of Patients Achieving a Decrease of at Least 2 Points in IGA in Treated Population Compared to Placebo Population From Baseline to Weeks 2, 4, 6, 8, and 10
Proportion of patients achieving a decrease of at least 2 points in IGA in treated population compared to placebo population from Baseline to Weeks 2, 4, 6, 8, and 10. The IGA scale awards a score of 0-4 based on a 5-point severity scale from clear to severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease). IGA uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment.
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Time frame: Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10
Change From Baseline in Eczema Area and Severity Index (EASI) in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10
Change from Baseline in EASI in treated population compared to placebo population at Weeks 2, 4, 6, 8, and 10. It quantifies the severity of a patient's AD based on both lesion severity and the percent of Body Surface Area (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 subscales used are summed in order to give a final EASI score. A decrease in EASI score represents a positive outcome for the patient.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10
Change From Baseline in Numeric Rating Scale (NRS) for Pruritus in Treated Population Compared to Placebo Population at Weeks 2, 4, 6, 8, and 10
Change from Baseline in Numeric Rating Scale (NRS) for pruritus in treated population compared to placebo population at Weeks 2, 4, 6, 8, and 10. Severity of pruritus related to AD will be self-assessed by patients daily using the NRS. Patients were asked to estimate the intensity of pruritus at its worst over the previous 24 hours. The Pruritus NRS is a single-question assessment tool that will be used to assess the patient's worst itch as a result of AD in the previous 24 hours. Patients scored their pruritus due to AD on a scale of 0 - 10, with 0 (no itch) and 10 (worst itch imaginable). Patients will complete the rating scale at screening and then daily starting at baseline through to the last study visit. A decrease in NRS represents a positive outcome for the patient.
Time frame: Baseline, Week 2, Week 4, Week 6, Week 8 and Week 10