Clinical study to investigate whether the new drug (LEO 152020) is efficient and safe for the treatment of a special type of urticaria that is induced by sweating.

Phase 1

• Conditions: cholinergic urticaria; MedDRA version: 21.1Level: LLTClassification code 10008675Term: Cholinergic urticariaSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-004961-38-DE
• Lead Sponsor: EO Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-21
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

- Subject with a history of CholU diagnosis for = 6 months
- Subject has active and uncontrolled CholU disease at the time of screening and randomisation, as defined by the following:
a.Urticaria control test (UCT) < 12 at screening
b.UASprovo = 3
- Age 18 or older
- Recent history (within 6 months of screening) with documented inadequate response to standard dose of H1 antihistamines

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

- Other clearly dominating forms* of urticaria as etiology 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To explore the efficacy of LEO 152020 compared with placebo in patients with cholinergic urticaria.;Secondary Objective: To evaluate the safety of LEO 152020 compared with placebo in patients with cholinergic urticaria.;Primary end point(s): Change from baseline in post-provocation Urticaria Activity Score (UASprovo).;Timepoint(s) of evaluation of this end point: end of each 7-day treatment period - visit 3 (day 8); visit 5 (day 22 or 29)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Number of treatment emergent adverse events (TEAE) per subject;Timepoint(s) of evaluation of this end point: Start of treatment period to 3 days after end treatment period