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

• Status: Recruiting
• Trial end date: 2021-12-20
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: LEO Pharma

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,

• Drugs with antihistamine properties including H1 antihistamines and H2 antihistamines 1 week prior to randomisation.