Back to resultsTrial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria
Primary Purpose
Cholinergic Urticaria
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
LEO 152020
LEO 152020 placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cholinergic Urticaria
Eligibility 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:
- 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.
Sites / Locations
- LEO Investigational Site
- LEO Investigational Site
- LEO Investigational Site
- LEO Investigational Site
- LEO Investigational Site
- LEO Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Active - Placebo
Placebo - Active
Arm Description
Patients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days
Patients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of treatment emergent adverse events per subject
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04853992
Brief Title
Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria
Official Title
Phase 2a Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
July 8, 2022 (Actual)
Study Completion Date
July 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholinergic Urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Each treatment period will last 7 days with a wash-out period of 7 days between treatments
Masking
ParticipantInvestigator
Masking Description
Placebo-controlled
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active - Placebo
Arm Type
Experimental
Arm Description
Patients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days
Arm Title
Placebo - Active
Arm Type
Experimental
Arm Description
Patients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days
Intervention Type
Drug
Intervention Name(s)
LEO 152020
Intervention Description
LEO 152020 is a small drug molecule which can bind to the histamine 4 receptor (H4R). LEO 152020 is a tablet for oral administration.
Intervention Type
Drug
Intervention Name(s)
LEO 152020 placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in post-provocation Urticaria Activity Score
Description
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.
Time Frame
After 7 days treatment period
Secondary Outcome Measure Information:
Title
Number of treatment emergent adverse events per subject
Time Frame
From treatment period start to 3 days after treatment end
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Expert
Organizational Affiliation
LEO Pharma
Official's Role
Study Director
Facility Information:
Facility Name
LEO Investigational Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
LEO Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
LEO Investigational Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
LEO Investigational Site
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
Facility Name
LEO Investigational Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
LEO Investigational Site
City
München
ZIP/Postal Code
80802
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
IPD Sharing URL
https://leopharmatrials.com/en
Learn more about this trial
Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria
We'll reach out to this number within 24 hrs