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NCT03562377 · ClinicalTrials.gov registry record · Phase 2
Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)
A Phase 2 study, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 215
- Enrollment target
NCT03562377 is a Phase 2 study that has completed, run by LEO Pharma. The registered enrollment target is 215 participants.
The verdict
NCT03562377, a Phase 2 study, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 215 participants
- Enrollment target
Study Summary
The purpose of this trial is to test if treatment with the trial drug, tralokinumab, can affect the body's immune response to vaccines. The trial will also evaluate the efficacy of tralokinumab when it is given concomitantly with vaccines. The trial includes a screening period of 2 to 6 weeks, a treatment period of 16 weeks (Weeks 0 to 16), and a 14-week off-treatment follow-up period for the assessment of safety (Weeks 16 to 30). Eligible subjects may transfer to an open-label, long-term trial at Week 16 or later.
Interventions
- DRUG Placebo
- DRUG Tralokinumab
- BIOLOGICAL Tdap vaccine
- BIOLOGICAL Meningococcal vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2018-07-13 |
| Est. Completion | 2019-11-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03562377
The ClinicalTrials.gov registry entry for NCT03562377 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 215 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 4 interventions - of which Placebo is the first listed.
NCT03562377 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03562377 about?
NCT03562377 is a clinical study titled "Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)". The purpose of this trial is to test if treatment with the trial drug, tralokinumab, can affect the body's immune response to vaccines. The trial will also evaluate the efficacy of tralokinumab when it is given concomitantly with vaccines. The trial includes a screening period of 2 to 6 weeks, a tr...
What is the current status of trial NCT03562377?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 215 participants. The study started on 2018-07-13. Estimated completion is 2019-11-22.
What interventions are being tested in trial NCT03562377?
The interventions under investigation include: Placebo (DRUG), Tralokinumab (DRUG), Tdap vaccine (BIOLOGICAL), Meningococcal vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03562377?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
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