Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Tralokinumab; Placebo
Intervention description: Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration.; Placebo contains the same excipients in the same concentration only lacking tralokinumab.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 277.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary objective:

      To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is
      superior to placebo in combination with TCS in treating severe AD in subjects who are not
      adequately controlled with or have contraindications to oral cyclosporine A (CSA).

      Secondary objectives:

      To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of
      AD, itch, and health-related quality of life compared to placebo in combination with TCS.

      To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in
      subjects who are not adequately controlled with or have contraindications to oral CSA
      compared to placebo in combination with TCS.
    

Eligibility criteria:

        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