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NCT03363854 · ClinicalTrials.gov registry record · Phase 3
Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3
A Phase 3 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 380
- Enrollment target
NCT03363854: Completed Phase 3 study, sponsored by LEO Pharma.
NCT03363854 is a Phase 3 study that has completed, run by LEO Pharma. The registered enrollment target is 380 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03363854, a Phase 3 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 380 participants
- Enrollment target
Study Summary
Primary objective: To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD). Secondary objectives: To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared with placebo in combination with TCS. To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 32 weeks.
Primary Outcome
IGA is used to evaluate the severity of atopic dermatitis. It is a 5-point score ranging from 0 (clear) to 4 (severe).
Interventions
- DRUG Placebo
- DRUG Tralokinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 380 participants |
| Start Date | 2018-02-22 |
| Est. Completion | 2019-09-26 |
| Phase | Phase 3 |
What the finished NCT03363854 record still lists
NCT03363854 is an interventional study that assigns participants to a tested intervention. The registered 380 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 (51% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03363854 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03363854 about?
NCT03363854 is a clinical study titled "Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3". Primary objective: To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD). Secondary objectives: To evaluate the efficacy of tralokinumab in combination with TCS on sev...
What is the current status of trial NCT03363854?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 380 participants. The study started on 2018-02-22. Estimated completion is 2019-09-26.
What interventions are being tested in trial NCT03363854?
The interventions under investigation include: Placebo (DRUG), Tralokinumab (DRUG).
Who is sponsoring clinical trial NCT03363854?
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 NCT03363854's enrollment target sits among peer trials
380 983rd of 2000 higher than 1,014 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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