Omalizumab in Severe and Refractory Solar Urticaria
- Sponsor
- Centre Hospitalier Universitaire de Besancon
- Study ID
- NCT02262130
- Phase
- PHASE2
- Status
- Completed
Conditions
- Solar Urticaria
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Omalizumab — DRUG
Study Details
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.
Key Dates
- Start date
- Sep 30, 2014
- Status verified
- Oct 2018
- Primary completion
- Sep 29, 2015
- Completion
- Sep 29, 2015
Study Design
- Enrollment
- 10 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: OmalizumabOmalizumab 300 mg W0, W4 and W8
Primary Outcome Measure
Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting) [ Time Frame: 4 weeks after the end of treatment ]