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

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

Detailed Description
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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.

Official Title
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Phase 2a Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria

Conditions
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Cholinergic Urticaria

Intervention / Treatment
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* Drug: LEO 152020
* Drug: LEO 152020 placebo


Participation Criteria
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Eligibility Criteria
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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: Urticaria control test < 12 at screening 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each treatment period will last 7 days with a wash-out period of 7 days between treatments
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active - Placebo<br>Patients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days | Drug: LEO 152020<br>* LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.<br>Drug: LEO 152020 placebo<br>* LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.<br>|
| Experimental: Placebo - Active<br>Patients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days | Drug: LEO 152020<br>* LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.<br>Drug: LEO 152020 placebo<br>* LEO 152020 placebo is a tablet for oral administration. LEO 152020 placebo contains the same excipients in the same concentration as the LEO 152020 tablet, except the medical ingredient, LEO 152020.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in post-provocation Urticaria Activity Score | The Urticaria Activity Score rates a participants' number of wheals and their itch severity on a scale from 0 to 6, with 6 being the most severe. | After 7 days treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment emergent adverse events per subject |  | From treatment period start to 3 days after treatment end |