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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2022-07-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria

NCT00525382

Urticaria

COMPLETED PHASE3

The Effect of Levocetirizine on Inflammatory Mediators in Dermatographism

NCT01008592

Rhinitis Urticaria

TERMINATED

A Study to Assess the Efficacy and Safety of AK002 in Subjects With Antihistamine-Resistant Chronic Urticaria

NCT03436797

Chronic Urticaria

COMPLETED PHASE2

A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).

NCT03137069

Urticaria

COMPLETED PHASE2

An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)

NCT01916967

Urticaria

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholinergic Urticaria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each treatment period will last 7 days with a wash-out period of 7 days between treatments

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Placebo-controlled

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active - Placebo

Patients will receive active treatment for 7 days, followed by a washout period of 7 days and then placebo for 7 days

Group Type EXPERIMENTAL

LEO 152020

Intervention Type DRUG

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

Intervention Type DRUG

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.

Placebo - Active

Patients will receive placebo for 7 days, followed by a washout period of 7 days and then active treatment for 7 days

Group Type EXPERIMENTAL

LEO 152020

Intervention Type DRUG

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

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No