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NCT03131648 · ClinicalTrials.gov registry record · Phase 3
Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1)
A Phase 3 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 802
- Enrollment target
NCT03131648: Completed Phase 3 study, sponsored by LEO Pharma.
NCT03131648 is a Phase 3 study that has completed, run by LEO Pharma. The registered enrollment target is 802 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03131648, a Phase 3 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 802 participants
- Enrollment target
Study Summary
Primary objective: To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis (AD). Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health related quality of life compared with placebo. Maintenance objective: To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16.
Primary Outcome
The IGA is an instrument used in clinical trials to rate the severity of the subject's global AD and is based on a 5-point scale ranging from 0 (clear) to 4 (severe).
Interventions
- DRUG Placebo
- DRUG Tralokinumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 802 participants |
| Start Date | 2017-05-30 |
| Est. Completion | 2019-10-10 |
| Phase | Phase 3 |
What the finished NCT03131648 record still lists
NCT03131648 is an interventional study that assigns participants to a tested intervention. The registered 802 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03131648 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03131648 about?
NCT03131648 is a clinical study titled "Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1)". Primary objective: To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis (AD). Secondary objectives: To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health related quality of life compared with placebo. Ma...
What is the current status of trial NCT03131648?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 802 participants. The study started on 2017-05-30. Estimated completion is 2019-10-10.
What interventions are being tested in trial NCT03131648?
The interventions under investigation include: Placebo (DRUG), Tralokinumab (DRUG).
Who is sponsoring clinical trial NCT03131648?
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 NCT03131648's enrollment target sits among peer trials
802 413th of 2000 higher than 1,587 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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