Last updated on September 2020

Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis Who Are Not Adequately Controlled With or Have Contraindications to Oral Cyclosporine A

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

Key Inclusion Criteria:

  • Age 18 and above
  • Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD
  • History of AD for 1 year or more
  • Subjects with a history within 1 year prior to screening of inadequate response to treatment with topical medications or subjects for whom topical treatments are otherwise medically inadvisable
  • AD involvement of 10% (or more) body surface area at screening and baseline (visit 3) according to component A of SCORAD
  • Documented history of either no previous CSA exposure and not currently a candidate for CSA treatment OR previous exposure to CSA in which case CSA treatment should not be continued or restarted
  • Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation

Key Exclusion Criteria:

  • Subjects for whom TCSs are medically inadvisable in the opinion of the investigator
  • Use of tanning beds or phototherapy (NBUVB, UVB, UVA1, PUVA), within 6 weeks prior to randomisation
  • Treatment with immunomodulatory medications or bleach baths within 4 weeks prior to randomisation
  • Treatment with topical phosphodiesterase-4 (PDE-4) inhibitor within 2 weeks prior to randomisation
  • Receipt of any marketed or investigational biologic agent (e.g. cell-depleting agents or dupilumab) within 6 months prior to randomisation or until cell counts return to normal, whichever is longer
  • History of any active skin infection within 1 week prior to randomisation
  • History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomisation
  • A helminth parasitic infection within 6 months prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
  • Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care
  • History of any known primary immunodeficiency disorder including a positive HIV test at screening, or the subject taking antiretroviral medications

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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