Vaccine Responses in Tralokinumab-Treated Atopic Dermatitis - ECZTRA 5 (ECZema TRAlokinumab Trial No. 5)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Tralokinumab; Placebo; Tdap vaccine; Meningococcal vaccine
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 administration.; Placebo contains the same excipients in the same concentration only lacking tralokinumab.; Tetanus (lockjaw), diphtheria (infection of the nose and throat), and pertussis (whooping cough) vaccine. All subjects will receive 1 dose at Week 12.; This vaccine is used to prevent meningococcal diseases (infection of the brain and spinal cord) and blood poisoning. All subjects will receive 1 dose at Week 12.
Intervention MeSH terms: Vaccines
Phase: Phase 2
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 tralokinumab/placebo will contain no evidence of their identity.
> Since tralokinumab and placebo are visually distinct and not matched for viscosity, they will be handled and administered by a qualified, unblinded healthcare professional at the trial site who will not be involved in the management of trial subjects.
Enrollment: 215.0
Sex: All
Minimum age: 18 Years
Maximum age: 54 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to test if treatment with the trial drug, tralokinumab, can
      affect the body's immune response to vaccines. The trial will also evaluate the efficacy of
      tralokinumab when it is given concomitantly with vaccines.> The trial includes a screening
      period of 2 to 6 weeks, a treatment period of 16 weeks (Weeks 0 to 16), and a 14-week
      off-treatment follow-up period for the assessment of safety (Weeks 16 to 30). Eligible
      subjects may transfer to an open-label, long-term trial at Week 16 or later.
    

Eligibility criteria:

        Inclusion Criteria:>

          -  Age 18 to 54 years>

          -  Diagnosis of AD as defined by 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 or for whom topical treatments are otherwise medically inadvisable>

          -  AD involvement of ≥10% body surface area at screening and baseline>

          -  An EASI score of ≥12 at screening and 16 at baseline>

          -  An IGA score of ≥3 at screening and at baseline >

          -  Subjects must have applied a stable dose of emollient twice daily (or more, as needed)
             for at least 14 days before randomisation>

        Exclusion Criteria:>

          -  Subjects for whom administration of the meningococcal vaccine provided in this trial
             is contraindicated or medically inadvisable, according to local label of the vaccine>

          -  Subjects for whom administration of the tetanus, diphtheria, and pertussis vaccine
             provided in this trial is contraindicated or medically inadvisable, according to local
             label of the vaccine>

          -  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 medications and/or systemic
             corticosteroids within 4 weeks prior to randomisation>

          -  Treatment with the topical medications topical corticosteroids (TCS), topical
             calcineurin inhibitor (TCI) or phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks
             prior to randomisation>

          -  Receipt of any vaccine (except influenza virus vaccines) within 3 months prior to
             screening, any meningococcal vaccine within 1 year prior to screening, or any
             tetanus-, diphtheria-, or pertussis-containing vaccine within 5 years prior to
             screening>

          -  Receipt of any marketed (i.e. immunoglobulin, anti-IgE) or investigational biologic
             agent, including dupilumab>

          -  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