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

Exclusion Criteria

• •Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of 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.
• •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.
• •Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals, or antiprotozoals within 2 weeks before the baseline visit.
• •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.