Efficacy and Safety Study of Orally Administered DS107 in Moderate to Severe Atopic Dermatitis Patients
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|ClinicalTrials.gov Identifier: NCT02864498|
Recruitment Status : Completed
First Posted : August 12, 2016
Last Update Posted : September 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Drug: DS107 Drug: Placebo||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||321 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||January 2017|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||June 2018|
Experimental: 1g Oral DS107
1g Oral DS107 to be administered once-daily for 8 weeks.
Experimental: 2g Oral DS107
2g Oral DS107 to be administered once daily for 8 weeks.
Placebo Comparator: Placebo
Placebo orally administered once-daily for 8 weeks.
- An IGA of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in IGA [ 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 [ Time Frame: 10 weeks ]
- Change from baseline in Eczema Area and Severity Index (EASI) [ Time Frame: 10 weeks ]
- Change from baseline in Numeric Rating Scale (NRS) for Pruritus [ Time Frame: 10 weeks ]
- Proportion of patients achieving a decrease of at least 2 points in IGA [ Time Frame: 10 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864498
|United States, Pennsylvania|
|DS Biopharma Site|
|Philadelphia, Pennsylvania, United States|
|DS Biopharma Site|
|Cape Town, South Africa|
|Study Chair:||Markus Weissbach, Ph.D||DS Biopharma|