Tralokinumab in Combination With Topical Corticosteroids for Moderate to Severe Atopic Dermatitis - ECZTRA 3 (ECZema TRAlokinumab Trial no. 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 topical
medications.

- 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 days before
randomisation.

Exclusion Criteria:

- Subjects for whom TCS are medically inadvisable e.g., due to important side effects or
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 systemic
corticosteroid within 4 weeks prior to randomisation.

- Treatment with TCS, topical calcineurin inhibitors (TCI), or topical phosphodiesterase
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.

- 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 is
obtained.

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

- Known primary immunodeficiency disorder.