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NCT04785326 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis
A Phase 3 study, sponsored by Dong-A ST Co..
- Completed
- Registry status
- Phase 3
- Development phase
- 598
- Enrollment target
NCT04785326: Completed Phase 3 study, sponsored by Dong-A ST Co..
NCT04785326 is a Phase 3 study that has completed, run by Dong-A ST Co.. The registered enrollment target is 598 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04785326, a Phase 3 study, has completed, sponsored by Dong-A ST Co..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 598 participants
- Enrollment target
Study Summary
This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate to severe chronic plaque psoriasis.
Primary Outcome
Percent change in the Psoriasis Area and Severity Index (PASI) score. PASI score is calculated by evaluating the severity of symptoms in each regions of the subject, and produces a numeric score ranging from 0 to 72. The higher the number, the more severe the symptoms. In general, a PASI score of 5 to 10 is considered moderate disease, and a score over 10 is considered severe. The primary endpoint of this clinical trial is % change in PASI, which has a value between 0 and 100, with 100 indicat
Interventions
- DRUG DMB-3115
- DRUG Stelara
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 598 participants |
| Start Date | 2021-04-28 |
| Est. Completion | 2022-11-16 |
| Phase | Phase 3 |
What the finished NCT04785326 record still lists
NCT04785326 is an interventional study that assigns participants to a tested intervention. The registered 598 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which DMB-3115 is the first listed.
NCT04785326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04785326 about?
NCT04785326 is a clinical study titled "Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis". This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate to severe chronic plaque psoriasis.
What is the current status of trial NCT04785326?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 598 participants. The study started on 2021-04-28. Estimated completion is 2022-11-16.
What interventions are being tested in trial NCT04785326?
The interventions under investigation include: DMB-3115 (DRUG), Stelara (DRUG).
Who is sponsoring clinical trial NCT04785326?
This trial is sponsored by Dong-A ST Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04785326's enrollment target sits among peer trials
598 640th of 2000 higher than 1,361 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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