Multicenter randomized, double-blind, placebo-controlled parallel clinical trial to assess efficacy and safety of Omalizumab (Xolair®) in a new indication: cholinergic urticaria.

Phase 1

• Conditions: Cholinergic urticaria; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-002770-43-ES
• Lead Sponsor: Clínica Universidad de Navarra/Universidad de Navarra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-14
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

- Adult female and male patients (age 14 years or older).
- Diagnosis of cholinergic urticaria trough clinical history and positive exercise challenge test.
- Non-respondent to supra therapeutic doses of antihistamines (defined as two folds the maximal dose included in the drug labeling)
- Written informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
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 24

Exclusion Criteria

- Pruritus related to dermatitis or other skin condition.
- Any systemic disease that hampers follow up or interpretation of data.
- Omalizumab treatment within the previous 12 months.
- Any contraindication included in the drug labeling.
- Any other conditions that do not allow the accomplishment of the clinical trial requisites, such as the abuse of drugs or alcohol.

Study & Design

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