Tralokinumab in combination with topical corticosteroids for moderate-to-severe atopic dermatitis ECZTRA 3 (ECZema TRAlokinumab trial no. 3)

Main criteria for inclusion:

• 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
• An EASI score of ≥ 12 at screening and 16 at baseline
• An IGA score of ≥ 3 at screening and at baseline
• A Worst Daily Pruritus NRS average score of ≥ 4 during the week prior to baseline
• Stable dose of emollients twice daily (or more, as needed) for at least 14 days before randomisation

Main criteria for exclusion:

• Subjects for whom TCSs 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, TCI, or topical phosphodiesterase 4 (PDE-4) inhibitor within 2 weeks prior to randomisation
• Receipt of any marketed biological therapy (i.e. immunoglobulin, antiimmunoglobulin 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 of informed consent is obtained
• Tuberculosis requiring treatment within 12 months prior to screening
• Known primary immunodeficiency disorder