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

Inclusion Criteria:

• 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 orintolerance) or subjects for whom these topical AD treatments are medicallyinadvisable.

• 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.

Exclusion Criteria:

• Active dermatologic conditions that may confound the diagnosis of AD or wouldinterfere 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 4weeks prior to baseline:

• Systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate,cyclosporine, azathioprine, mycophenolate mofetil, JAK inhibitors).

• Systemic corticosteroid use (excludes topical, inhaled, ophthalmic, orintranasal 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 6months 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.