Clinical trial NCT04853992: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cholinergic Urticaria
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: LEO Pharma
First posted: 2021-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each treatment period will last 7 days with a wash-out period of 7 days between treatments
Primary purpose: TREATMENT

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.

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:

  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.

Primary outcomes:
measure: Change From Baseline in Post-provocation Urticaria Activity Score (UASprovo)
timeFrame: Baseline to Day 7
Secondary outcomes:
measure: Number of Treatment Emergent Adverse Events
timeFrame: 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)
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: LEO Investigational Site
city: Berlin
country: Germany
facility: LEO Investigational Site
city: Dresden
country: Germany
facility: LEO Investigational Site
city: Freiburg
country: Germany
facility: LEO Investigational Site
city: Kiel
country: Germany
facility: LEO Investigational Site
city: München
country: Germany
facility: LEO Investigational Site
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: