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Efficacy and Safety Study of Orally Administered DS107 in Moderate to Severe Atopic Dermatitis Patients

Atopic Dermatitis Clinical Trial

Official title:
A Randomised, Double-blind, Placebo-controlled, Phase 2b Study to Assess the Efficacy and Safety of Orally Administered DS107 in Patients With Moderate to Severe Atopic Dermatitis

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02864498
Study type Interventional
Source DS Biopharma
Contact
Status Completed
Phase Phase 2
Start date January 2017
Completion date June 2018
View Details
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