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

A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Subjects With Moderate to Severe Atopic Dermatitis

Primary objective:

To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD).

Secondary objectives:

To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared with placebo in combination with TCS.

To assess the safety of tralokinumab in combination with TCS when used to treat moderate-to-severe AD for 32 weeks.

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 within 3 months 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 is obtained.
• Tuberculosis requiring treatment within the 12 months prior to screening.
• Known primary immunodeficiency disorder.