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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 is a Phase 3 study that has completed, run by LEO Pharma. The registered enrollment target is 802 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03131648
The ClinicalTrials.gov registry entry for NCT03131648 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 802 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is LEO Pharma, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03131648 reports 0 study locations.
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.
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