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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04853992
Recruitment Status : Completed
First Posted : April 22, 2021
Last Update Posted : September 2, 2022
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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

Condition or disease Intervention/treatment Phase
Cholinergic Urticaria Drug: LEO 152020 Drug: LEO 152020 placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Each treatment period will last 7 days with a wash-out period of 7 days between treatments
Masking: Double (Participant, Investigator)
Masking Description: Placebo-controlled
Primary Purpose: Treatment
Official Title: Phase 2a Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria
Actual Study Start Date : May 10, 2021
Actual Primary Completion Date : July 8, 2022
Actual Study Completion Date : July 11, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arms and Interventions
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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
LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.

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.
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
LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.

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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in post-provocation Urticaria Activity Score [ Time Frame: After 7 days treatment period ]
    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.


Secondary Outcome Measures :
  1. Number of treatment emergent adverse events per subject [ Time Frame: From treatment period start to 3 days after treatment end ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853992


Locations
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Germany
LEO Investigational Site
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
Sponsors and Collaborators
LEO Pharma
Investigators
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Study Director: Medical Expert LEO Pharma
More Information
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT04853992    
Other Study ID Numbers: EXP-2177
2020-004961-38 ( EudraCT Number )
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: September 2, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data is available to request after results of the trial are available on leopharmatrials.com
Access Criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
URL: https://leopharmatrials.com/en

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urticaria
Skin Diseases, Vascular
Skin Diseases
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases