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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: Completed Phase 2 study, sponsored by LEO Pharma.
NCT03562377 is a Phase 2 study that has completed, run by LEO Pharma. The registered enrollment target is 215 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The antibody response to Tdap vaccine will be assessed by measuring serum anti-tetanus IgG by an immunoassay. A positive response is defined as a 3-fold IgG increase compared to Week 12 if IgG ≤1.0 IU/mL at Week 12; or IgG ≥2.5 IU/mL if IgG \>1.0 IU/mL at Week 12.
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 |
What the finished NCT03562377 record still lists
NCT03562377 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03562377 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03562377's enrollment target sits among peer trials
215 289th of 2000 higher than 1,711 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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