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NCT03817190 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis
A Phase 2 study, sponsored by DS Biopharma.
- Terminated
- Registry status
- Phase 2
- Development phase
- 219
- Enrollment target
NCT03817190: Clinical Trial Phase 2 study, sponsored by DS Biopharma.
NCT03817190 is a Phase 2 study that was terminated before completion, run by DS Biopharma. The registered enrollment target is 219 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03817190, a Phase 2 study, was terminated before completion, sponsored by DS Biopharma.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 219 participants
- Enrollment target
Study Summary
The objective of this study is to compare the efficacy and safety of orally administered DS107 (2g) versus placebo in the treatment of moderate to severe Atopic Dermatitis (AD). Oral DS107/Placebo capsules will be administered for 16 weeks. The study will enrol approximately 220 subjects.
Primary Outcome
Proportion of patients achieving a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-ADTM) score of 0 (clear) or 1 (almost clear) and a decrease of at least 2 points in vIGA-ADTM in treated population compared to placebo population from Baseline at Week 16 using GLMM.The vIGA-ADTM 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). The scale u
Interventions
- DRUG Placebo
- DRUG DS107
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 219 participants |
| Start Date | 2019-09-19 |
| Est. Completion | 2020-09-03 |
| Phase | Phase 2 |
Why NCT03817190 stopped before completion
NCT03817190 is an interventional study that assigns participants to a tested intervention. The registered 219 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03817190 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03817190 about?
NCT03817190 is a clinical study titled "Efficacy and Safety of Orally Administered DS107 in Adult Patients With Moderate to Severe Atopic Dermatitis". The objective of this study is to compare the efficacy and safety of orally administered DS107 (2g) versus placebo in the treatment of moderate to severe Atopic Dermatitis (AD). Oral DS107/Placebo capsules will be administered for 16 weeks. The study will enrol approximately 220 subjects.
What is the current status of trial NCT03817190?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 219 participants. The study started on 2019-09-19. Estimated completion is 2020-09-03.
What interventions are being tested in trial NCT03817190?
The interventions under investigation include: Placebo (DRUG), DS107 (DRUG).
Who is sponsoring clinical trial NCT03817190?
This trial is sponsored by DS Biopharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03817190's enrollment target sits among peer trials
219 283rd of 2000 higher than 1,717 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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