Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3

Inclusion Criteria:

• Age 18 and above.

• Diagnosis of AD as defined by the 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 topicalmedications.

• 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 daysbefore randomisation.

Exclusion Criteria:

• Subjects for whom TCS are medically inadvisable e.g., due to important side effectsor safety risks in the opinion of the investigator.

• 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 systemiccorticosteroid within 4 weeks prior to randomisation.

• Treatment with TCS, topical calcineurin inhibitors (TCI), or topicalphosphodiesterase 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 within 3months or 5 half-lives, whichever is longer prior to randomisation.

• 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 isobtained.

• Tuberculosis requiring treatment within the 12 months prior to screening.

• Known primary immunodeficiency disorder.