The Handel study is a double-blind, placebo-controlled, randomized clinical trial that will investigate the efficacy and safety of alitretinoin in the treatment of severe chronic hand eczema (CHE) that has not responded to potent topical steroids. In the Handel trial participants will be randomized to receive oral alitretinoin or placebo for up to 24 weeks.
The primary endpoint of the clinical trial is the response rate as measured by the achievement of clear or almost clear hands according to the physician’s global assessment. Assessments of safety will be similar to that employed in previous large studies. Likewise a pregnancy risk management plan for female patients of childbearing age will be established. The study will take place at approximately 90 sites across the US and is planned to enroll 600 patients.
Anthony Man, CEO of Basilea Pharmaceutica, said: “Alitretinoin has already been approved in several EU member states as therapy for severe chronic hand eczema unresponsive to potent topical steroids. This study is designed to evaluate the safety and efficacy of the drug in a US patient population.”