Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria

Phase 2

Completed

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

Detailed 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Placebo - Active	LEO 152020	Patients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days
Active - Placebo	LEO 152020 placebo	Patients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days
Placebo - Active	LEO 152020 placebo	Patients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days
Active - Placebo	LEO 152020	Patients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)	Baseline to Day 7	The Urticaria Activity Score (UAS) rates a participants' number of wheals and their itch severity on a scale from 0 to 6, with 6 being the most severe. UAS is assessed after provocation of urticaria by moderate exercise to cause sweating.

Secondary Outcome Measures

Name	Time	Method
Number of Treatment Emergent Adverse Events	From start of each treatment period (day 1 for the 1st treatment period or day 15 or 22 for the 2nd treatment period) until 3 days after end of each treatment period (day 11 for the 1st treatment period or day 25 or 32 for the 2nd treatment period)