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A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Effect of Tralokinumab on Vaccine Antibody Responses in Adults With Moderate-to-severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

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Trial Profile

A Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Effect of Tralokinumab on Vaccine Antibody Responses in Adults With Moderate-to-severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 02 Aug 2024

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At a glance

  • Drugs Tralokinumab (Primary) ; DTaP vaccine; Meningococcal vaccine conjugate
  • Indications Atopic dermatitis
  • Focus Pharmacodynamics
  • Acronyms ECZTRA 5
  • Sponsors LEO Pharma

Most Recent Events

  • 26 Oct 2022 According to a LEO Pharma media release, results from a pooled safety analysis of Adbry (tralokinumab-ldrm) from three pivotal Phase 3 trials (ECZTRA 1, 2, and ECZTRA 3), Phase 2 (ECZTRA 5) and Phase 2b trials of adult patients with moderate-to-severe atopic dermatitis (AD) presented at British Journal of Dermatology
  • 12 Oct 2021 Results (n=2285) of pooled analysis of three phase 3 trials, ECZTRA 1 (NCT03131648), ECZTRA 2 (NCT03160885), and ECZTRA 3 (NCT03363854) one phase 2 trial, ECZTRA 5 (NCT03562377); and one phase 2b dose-finding trial (NCT02347176) assessing the occurrence of and risk factors for conjunctivitis in patients with patients with moderate-to-severe atopic dermatitis, published in the British Journal of Dermatology.
  • 17 Mar 2021 Primary endpoint (Positive anti-meningococcal response at Week 16) , has been met according to results published in the Journal of the American Academy of Dermatology

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