Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7

A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-centre, Phase 3 Trial Investigating the Efficacy, Safety, and Tolerability of Tralokinumab Administered in Combination With Topical Corticosteroids to Adult Subjects With 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 severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA).

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 to placebo in combination with TCS.

To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS.

Key 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 or more
• Subjects with a history within 1 year prior to screening of inadequate response to treatment with topical medications or subjects for whom topical treatments are otherwise medically inadvisable
• AD involvement of 10% (or more) body surface area at screening and baseline (visit 3) according to component A of SCORAD
• Documented history of either no previous CSA exposure and not currently a candidate for CSA treatment OR previous exposure to CSA in which case CSA treatment should not be continued or restarted
• Subjects must have applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation

Key Exclusion Criteria:

• Subjects for whom TCSs are medically inadvisable in the opinion of the investigator
• Use of tanning beds or phototherapy (NBUVB, UVB, UVA1, PUVA), within 6 weeks prior to randomisation
• Treatment with immunomodulatory medications or bleach baths within 4 weeks prior to randomisation
• Treatment with topical phosphodiesterase-4 (PDE-4) inhibitor within 2 weeks prior to randomisation
• Receipt of any marketed or investigational biologic agent (e.g. cell-depleting agents or dupilumab) within 6 months prior to randomisation or until cell counts return to normal, whichever is longer
• History of any active skin infection within 1 week prior to randomisation
• History of a clinically significant infection (systemic infection or serious skin infection requiring parenteral treatment) within 4 weeks prior to randomisation
• A helminth parasitic infection within 6 months prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy
• Tuberculosis requiring treatment within the 12 months prior to screening. Evaluation will be according to local guidelines as per local standard of care
• History of any known primary immunodeficiency disorder including a positive HIV test at screening, or the subject taking antiretroviral medications