A phase IV, multi-arm muti-stage, assessor blind randomised control trial comparing the effectiveness, tolerability and cost effectiveness of systemic treatments for adults with moderate-severe atopic eczema (BEACON)

Research summary

BEACON is a UK based,multicentre,1 year,assessor-blind,parallel group,superiority,randomised controlled trial. The primary aim of the trial is to determine the effectiveness of methotrexate and dupilumab compared with ciclosporin. The primary endpoint is change in objective disease severity at 6 months,presented as mean absolute change from baseline,using the Eczema Area Severity Index (EASI,blinded assessment). Patients will be randomised 1:1:1 to methotrexate,dupilumab or ciclosporin for 6 months (optional dose increase at 3 months for those on methotrexate or ciclosporin as per clinical practice). Responders (defined as those achieving a 50% improvement in their objective disease severity measured using the Eczema Area and Severity Index (EASI),and a ≥ 4 point improvement in quality of life score (Dermatology Life Quality Index (DLQI)) will continue treatment up to 1 year. Non-responders will switch treatment in a pre-defined way to reflect clinical practice (methotrexate to dupilumab,ciclosporin to dupilumab,dupilumab to methotrexate) and continue this treatment for 6 months.

Principal Investigator

Antonia Lloyd-lavery

Contact us

Email: melanie.westmoreland@ouh.nhs.uk

IRAS number

1004703