NCT02262130

Omalizumab in Severe and Refractory Solar Urticaria

Phase 2 Multicentric Study Evaluating the Efficacy of Omalizumab in Idiopathic Severe and Refractory Solar Urticaria

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Solar urticaria is a rare disease, with a usual favourable outcome with photoprotection and with anti H1 histamines. Nevertheless, some cases can be severe and refractory to this usual treatment, leading to a large impact on quality of life. New treatment options are warranted. The investigators aim to test the efficacy and the safety of omalizumab, an anti-IgE antibody recently approved in chronic spontaneous urticaria, in this setting.

Detailed description

This is an open-labelled multicentric phase II study testing the efficacy and the safety of omalizumab 300 mg (W0, W4 and W8) in patients affected with severe and refractory solar urticaria.

Conditions

• Solar Urticaria

Interventions

Type	Name	Description
DRUG	Omalizumab

Timeline

• Start date: 2014-09-30
• Primary completion: 2015-09-29
• Completion: 2015-09-29
• First posted: 2014-10-10
• Last updated: 2018-10-12
• Results posted: 2018-10-12

Locations

13 sites across 1 country: France