Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3
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)
Masking description: Neither the subject nor any of the investigator or LEO staff who are involved in the treatment or clinical evaluation and monitoring of the subjects will be aware of the treatment received. The packaging and labelling of the investigational medicinal products (IMPs) will contain no evidence of their identity.
Since tralokinumab and placebo are visually distinct and not matched for viscosity, IMP will be handled and administered by a qualified, unblinded health-care professional at the site who will not be involved in the management of trial subjects and who will not perform any of the assessments.
Enrollment: 380.0
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 moderate-to-severe atopic dermatitis
      (AD).

      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 with placebo in combination with TCS.

      To assess the safety of tralokinumab in combination with TCS when used to treat
      moderate-to-severe AD for 32 weeks.
    

Eligibility criteria:

        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.

          -  Subjects who have a recent history of inadequate response to treatment with topical
             medications.

          -  AD involvement of ≥10% body surface area at screening and baseline.

          -  Stable dose of emollient twice daily (or more, as needed) for at least 14 days before
             randomisation.

        Exclusion Criteria:

          -  Subjects for whom TCS are medically inadvisable e.g., due to important side effects or
             safety risks in the opinion of the investigator.

          -  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 TCS, topical calcineurin inhibitors (TCI), or topical phosphodiesterase
             4 (PDE-4) inhibitor within 2 weeks prior to randomisation.

          -  Receipt of any marketed biological therapy (i.e. immunoglobulin, anti- immunoglobulin
             E) including dupilumab or investigational biologic agents within 3 months or 5
             half-lives, whichever is longer 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.

          -  Tuberculosis requiring treatment within the 12 months prior to screening.

          -  Known primary immunodeficiency disorder.