Cholinergic Urticaria Clinical Trial
Official title:
Phase 2a Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria
Phase 2a trial to assess the efficacy and safety of LEO 152020 in adult patients with cholinergic urticaria
This is a phase 2a, randomised, double-blind, placebo-controlled, cross-over trial conducted in Germany at 3-6 sites. Subjects will be randomised to one of two treatment sequences (A and B). Each treatment period will last 7 days with a wash-out period of 7 days between treatments. Half of the subjects will start with treatment A followed by treatment B while the other half will start with treatment B followed by treatment A. A safety follow-up visit will be performed 3 days after last dose of the tested medication. The main assessment is an urticaria activity score. After a Pulse-controlled ergometry (PCE) provocation test subjects will be rated on their number of wheals and their itch severity, resulting in a sum score ranging from 0 to 6 points. ;
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