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.

Main Inclusion Criteria:

• Subject with a history of Cholinergic urticaria diagnosis for ≥ 6 months

• Subject has active and uncontrolled Cholinergic urticaria disease at the time of screening and randomisation, as defined by the following:

  1. Urticaria control test < 12 at screening
  2. Urticaria Activity Score post-provocation ≥ 3

• Recent history (within 6 months of screening) with documented inadequate response to standard dose as to marketing authorization of H1 antihistamines.

Main Exclusion Criteria:

• Other clearly dominating forms* of urticaria as aetiology for wheal and flare type reactions

  *These diseases are allowed as comorbidities, if cholinergic urticaria is the dominating form of chronic urticaria,

• Systemic immunosuppressive medications within 4 weeks prior to screening,

• Systemic drugs (e.g. oral drug) with antihistamine properties including H1 antihistamines and some antidepressants (e.g. tricyclic antidepressants) and H2 antihistamines 1 week prior to randomisation and throughout the trial. However, topical antihistamines in the form of nasal spray and eyedrops are allowed in the standard prescribed dose.

De-identified Individual Participant Data can be made available to researchers and is subject to approved scientifically sound research proposal and signed data-sharing agreement.

From first trial related activity (up to 21 days before day 1 in first treatment period till 3 days after end of second treatment period (day 25 or 32).

Placebo-controlled