drugset / Trial / NCT03562377

Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)

NCT03562377

Phase 2 Completed 215 enrolled LEO Pharma
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2018-07-13
Primary completion
2019-09-17
Completion
2019-11-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Adacel Vaccine 1 unknown
Subject Meningococcal Vaccine Vaccine 1 unknown
Subject Tralokinumab Monoclonal antibody Subcutaneous

Indications