Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1)

Inclusion Criteria:

- Age 18 and above

- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.

- Diagnosis of AD for ≥1 year.

- Subjects who have a recent history of inadequate response to treatment with topical
medications or for whom topical treatments are otherwise medically inadvisable.

- AD involvement of ≥10% body surface area at screening and baseline.

- Subjects must have applied a stable dose of emollient twice daily (or more, as needed)
for at least 14 days before randomisation

Exclusion Criteria:

- 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 topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI)
within 2 weeks 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 is
obtained.

- History of anaphylaxis following any biologic therapy.

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

- Known primary immunodeficiency disorder.

- Alanine aminotransferase or aspartate aminotransferase level ≥2.0 times the upper
limit of normal at screening.

- Positive hepatitis B surface antigen, hepatitis B surface antibody, hepatitis B core
antibody or hepatitis C virus antibody serology at screening.