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

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

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

Study Overview

• Status: Completed
• Conditions: Cholinergic Urticaria
• Intervention / Treatment: Drug: LEO 152020 placebo; Drug: LEO 152020

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • LEO Investigational Site
  • Berlin, Germany, 10117
    • LEO Investigational Site
  • Dresden, Germany, 01307
    • LEO Investigational Site
  • Freiburg, Germany, 79104
    • LEO Investigational Site
  • Kiel, Germany, 24105
    • LEO Investigational Site
  • München, Germany, 80802
    • LEO Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active - Placebo; 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 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.; 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.
Experimental: Placebo - Active; 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 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: JW Pharmaceutical
• Collaborators: LEO Pharma
• Investigators: Study Director: Medical Expert, LEO Pharma

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): July 8, 2022
• Study Completion (Actual): July 11, 2022

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Skin Diseases, Vascular; Hypersensitivity; Urticaria
• Other Study ID Numbers: EXP-2177; 2020-004961-38 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
• IPD Sharing Time Frame: Data is available to request after results of the trial are available on leopharmatrials.com
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No