At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 10 enrolled
Drug / intervention
Omalizumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
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Phase 2 Multicentric Study Evaluating the Efficacy of Omalizumab in Idiopathic Severe and Refractory Solar Urticaria
Centre Hospitalier Universitaire de Besancon·interventional·Posted Oct 10, 2014·Updated Oct 12, 2018
In Brief
A Phase 2 clinical trial evaluating Omalizumab for Solar Urticaria. Completed, enrolled 10 participants across 13 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolar Urticaria
CountriesFrance
CollaboratorsNovartis
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartSep 2014
First PostedOct 2014
Primary CompletionSep 2015
TodayJul 2026
First PostedOct 10, 2014
Enrollment StartSep 30, 2014
Primary CompletionSep 29, 2015
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 11.7 years ago
Interventions
Omalizumabdrug