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Clinical Trial Summary

Phase 2a trial to assess the efficacy and safety of LEO 152020 in adult patients with cholinergic urticaria


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04853992
Study type Interventional
Source LEO Pharma
Contact LEO Pharma
Phone (+1) 877-557-1168
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date April 21, 2021
Completion date December 20, 2021

See also
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Recruiting NCT03749148 - Cholinergic Urticaria - Efficacy of Dupilumab Phase 2
Recruiting NCT04513548 - Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria Phase 1