Tralokinumab in Combination With Topical Corticosteroids in Japanese Subjects With Moderate-to-severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Tralokinumab; Placebo; Topical corticosteroids (TCS)
Intervention description: Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 subclass that specifically binds to human interleukin-13 (IL-13) and blocks the interaction with IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.; Placebo contains the same excipients in the same concentration only lacking tralokinumab.; TCS administered as needed.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Neither the trial participant nor any of the investigator or LEO pharma staff who are involved in the treatment or clinical evaluation and monitoring of the participants will be aware of the treatment received. The packaging and labelling of the investigational medicinal product (IMP) 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 healthcare professional at the site who will not be involved in the management of trial participants and who will not perform any of the assessments.
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary objective:

      To evaluate the efficacy of tralokinumab in combination with topical corticosteroids (TCS)
      compared with 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, health-related quality of life, and health care resource utilisation 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 16 weeks.
    

Eligibility criteria:

        Key inclusion criteria:

          -  Japanese subject aged 18 years and above.

          -  Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.

          -  History of AD for 1 year or more.

          -  A recent history (within 1 year before screening) of inadequate response to treatment
             with topical medication.

          -  AD involvement of 10% or more body surface area at screening and at baseline according
             to component A of SCORAD.

          -  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 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 or would
             interfere with assessment of treatment.

          -  Use of tanning beds or phototherapy within 6 weeks prior to randomisation.

          -  Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic
             corticosteroids within 4 weeks prior to randomisation.

          -  Treatment with TCS, topical calcineurin inhibitors, topical phosphodiesterase-4
             inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to randomisation.

          -  Receipt of any marketed biological therapy (i.e. immunoglobulin, anti-immunoglobulin
             E) including dupilumab or investigational biologic agents 3 to 6 months prior to
             randomisation.

          -  Active skin infections 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.