Tralokinumab Monotherapy for Adolescent Subjects With Moderate to Severe Atopic Dermatitis - ECZTRA 6 (ECZema TRAlokinumab Trial no. 6).
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Tralokinumab; Placebos
Intervention description: Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 (IgG4) subclass that specifically binds to human interleukin (IL) 13 and blocks interaction with the IL-13 receptors.; 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 healthcare 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: 301.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Primary objective:

      To evaluate the efficacy of subcutaneous (SC) administration of tralokinumab compared with
      placebo in treating adolescent subjects (age 12 to <18 years) with moderate-to-severe AD.

      Secondary objectives:

      To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and
      health-related quality of life compared with placebo.

      To investigate the safety, immunogenicity, and tolerability of SC administration of
      tralokinumab compared with placebo when used to treat adolescent subjects (age 12 to <18
      years) with moderate-to-severe AD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 12 to 17.

          -  Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.

          -  History of AD for ≥1 year.

          -  History of topical corticosteroid (TCS; Europe: Class 3 or higher; US: Class 4 or
             lower) and/or topical calcineurin inhibitor (TCI) treatment failure or subjects for
             whom these topical AD treatments are medically inadvisable.

          -  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:

          -  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, 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.

          -  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.