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

Cholinergic Urticaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04853992
• Other study ID #: EXP-2177
• Secondary ID: 2020-004961-38
• Status: Completed
• Phase: Phase 2
• Start date: May 10, 2021
• Est. completion date: July 11, 2022

Study information

• Verified date: April 2024
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 11, 2022
• Est. primary completion date: July 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholinergic Urticaria
• Urticaria

Intervention

Drug:
• LEO 152020
LEO 152020 is a small drug molecule which can block the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.
• LEO 152020 placebo
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.

Locations

Country	Name	City	State
Germany	LEO Investigational Site	Aachen
Germany	LEO Investigational Site	Berlin
Germany	LEO Investigational Site	Dresden
Germany	LEO Investigational Site	Freiburg
Germany	LEO Investigational Site	Kiel
Germany	LEO Investigational Site	München

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)	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.	Baseline to Day 7
Secondary	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)