Last updated on April 2018

Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Age 18 and above
  • Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
  • Diagnosis of AD for 1 year.
  • Subjects who have a recent history of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable.
  • AD involvement of 10% body surface area at screening and baseline.
  • Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation

Exclusion Criteria:

  • Active dermatologic conditions that may confound the diagnosis of AD.
  • Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
  • Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to randomisation.
  • Treatment with topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI) within 2 weeks prior to randomisation.
  • Active skin infection within 1 week prior to randomisation.
  • Clinically significant infection within 4 weeks prior to randomisation.
  • A helminth parasitic infection within 6 months prior to the date informed consent is obtained.
  • History of anaphylaxis following any biologic therapy.
  • Tuberculosis requiring treatment within the 12 months prior to screening.
  • Known primary immunodeficiency disorder.
  • Alanine aminotransferase or aspartate aminotransferase level 2.0 times the upper limit of normal at screening.
  • Positive hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B core antibody or hepatitis C virus antibody serology at screening.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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