Status:
COMPLETED
Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria
Lead Sponsor:
JW Pharmaceutical
Collaborating Sponsors:
LEO Pharma
Conditions:
Cholinergic Urticaria
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 trea...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04853992
Start Date
May 10 2021
End Date
July 11 2022
Last Update
April 22 2024
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
LEO Investigational Site
Aachen, Germany, 52074
2
LEO Investigational Site
Berlin, Germany, 10117
3
LEO Investigational Site
Dresden, Germany, 01307
4
LEO Investigational Site
Freiburg im Breisgau, Germany, 79104