Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)

Prior treatment

• Treatment with topical PDE-4 inhibitor within 2 weeks prior to randomization.
• Treatment with the following immunomodulatory medications or bleach baths within 4 weeks prior to baseline:
  • Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors).
  • Systemic corticosteroid use (excludes topical, inhaled, ophthalmic, or intranasal delivery).
  • 3 or more bleach baths during any week within the 4 weeks.
• Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals, or antiprotozoals within 2 weeks before the baseline visit.

Other illness

• Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
• History of malignancy at any time before the baseline visit.
• History of anaphylaxis following any biological therapy.
• History of immune complex disease.
• Active or suspected endoparasitic infections.
• History of past or current tuberculosis or other mycobacterial infection.
• Established diagnosis of a primary immunodeficiency disorder.

Lab values

• Receipt of any marketed biological therapy or investigational biologic agents (including immunoglobulin, anti-IgE, or dupilumab):
  • Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
  • Other biologics (including dupilumab): within 3 months or 5 halflives, whichever is longer, prior to baseline.

• Diagnosis of AD (as defined by Hanifin and Rajka criteria for AD).
• Age 6 to \<12 years at time of the baseline visit.
• Body weight at baseline of ≥17 kg.
• History of AD for ≥ 12 months at screening.
• History of TCS and/or TCI treatment failure (due to inadequate response or intolerance) or subjects for whom these topical AD treatments are medically inadvisable.
• AD involvement of ≥10% body surface area at screening and baseline.
• An EASI score of ≥16 at screening and at baseline.
• An Investigator's Global Assessment (IGA) score of ≥3 at screening and at baseline.
• Emollient twice daily (or more) for at least 14 days prior to baseline.