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NCT03556592 · ClinicalTrials.gov registry record · Phase 1
Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4
A Phase 1 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT03556592: Completed Phase 1 study, sponsored by LEO Pharma.
NCT03556592 is a Phase 1 study that has completed, run by LEO Pharma. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03556592, a Phase 1 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this trial is to investigate if tralokinumab changes the metabolism of selected CYP substrates in adults with moderate-to-severe AD after: * 14 weeks of treatment with tralokinumab * a single dose of tralokinumab
Primary Outcome
AUC-last = area under the plasma concentration curve from time 0 to the last quantifiable observation
Interventions
- DRUG Omeprazole
- DRUG Tralokinumab
- DRUG Caffeine
- DRUG Warfarin
- DRUG Metoprolol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-08-13 |
| Est. Completion | 2020-06-20 |
| Phase | Phase 1 |
What the finished NCT03556592 record still lists
NCT03556592 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 5 interventions - of which Omeprazole is the first listed.
NCT03556592 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03556592 about?
NCT03556592 is a clinical study titled "Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4". The purpose of this trial is to investigate if tralokinumab changes the metabolism of selected CYP substrates in adults with moderate-to-severe AD after: * 14 weeks of treatment with tralokinumab * a single dose of tralokinumab
What is the current status of trial NCT03556592?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2018-08-13. Estimated completion is 2020-06-20.
What interventions are being tested in trial NCT03556592?
The interventions under investigation include: Omeprazole (DRUG), Tralokinumab (DRUG), Caffeine (DRUG), Warfarin (DRUG), Metoprolol (DRUG).
Who is sponsoring clinical trial NCT03556592?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03556592's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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