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NCT02864498 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of Orally Administered DS107 in Moderate to Severe Atopic Dermatitis Patients
A Phase 2 study of Atopic Dermatitis, sponsored by DS Biopharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 321
- Enrollment target
- 2
- Study locations
NCT02864498: Completed Phase 2 study of Atopic Dermatitis, sponsored by DS Biopharma.
NCT02864498 is a Phase 2 study of Atopic Dermatitis that has completed, run by DS Biopharma. The registered enrollment target is 321 participants, below the 607-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (47% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02864498, a Phase 2 study of Atopic Dermatitis, has completed, sponsored by DS Biopharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 321 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG DS107
Study Locations (2)
Pennsylvania
- DS Biopharma Site - Philadelphia
Other
- DS Biopharma Site - Cape Town
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 321 participants |
| Start Date | 2017-01 |
| Est. Completion | 2018-06 |
| Phase | Phase 2 |
What the finished NCT02864498 record still lists
NCT02864498 is an interventional study that assigns participants to a tested intervention. The registered 321 participants enrollment target is mid-sized for trials with a published cap, below the 607-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02864498 reports a single indexed study location in Pennsylvania, Other.
Frequently Asked Questions
What is clinical trial NCT02864498 about?
NCT02864498 is a clinical study titled "Efficacy and Safety Study of Orally Administered DS107 in Moderate to Severe Atopic Dermatitis Patients". 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 su...
What is the current status of trial NCT02864498?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 321 participants. The study started on 2017-01. Estimated completion is 2018-06.
What conditions does trial NCT02864498 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT02864498?
The interventions under investigation include: Placebo (DRUG), DS107 (DRUG).
Who is sponsoring clinical trial NCT02864498?
This trial is sponsored by DS Biopharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02864498 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02864498's enrollment target sits among peer trials
321 40th of 150 higher than 111 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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