Omalizumab in Severe and Refractory Solar Urticaria

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Solar Urticaria

Intervention / Treatment
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* Drug: Omalizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > or equal to 18 years, Appearance of wheals within 15 min after sun exposure and lasting < 2 hr in the shade, Wheals reproducible with phototesting: appearance after exposure to UVB, UVA or visible light less than 30 min after exposure and lasting < 2 hr, Severity criteria: Very large effect on quality of life, with Dermatology Life Quality Index (DLQI) > 10, and At least 1 of the following: involvement of the face, per annual eruption, extension of wheals on the non-photoexposed skin, SU triggered by artificial light, SU flares accompanied by bronchospasm or syncope. Refractory criteria: Resistance to photoprotection with sunscreen with sun protection factor ≥ 50, and Resistance to administration of an association of 2 different antihistamines during 3 months or to photodesensitization. Exclusion Criteria: Contra indication to omalizumab Previous treatment with omalizumab

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omalizumab<br>Omalizumab 300 mg W0, W4 and W8 | Drug: Omalizumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting) | Proportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting). A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD. | 4 weeks after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6 | Proportion of patients for whom the treatment with omalizumab allowed achieving DLQI < 6. The index extends from 0 to 30: 0 - 1 = no effect at all on patient's life / 2 - 5 = small effect on patient's life / 6 - 10 = moderate effect on patient's life / 11 - 20 = very large effect on patient's life / 21 - 30 = extremely large effect on patient's life | 4 and 12 weeks after the end of treatment | 
| Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting) | Proportion of patients with minimal urticarial dose (MUD) increased compared to baseline, under experimental conditions (assessed by phototesting). A small area of skin is exposed to increasing UVA doses with a solar simulator until an allergic reaction appears. The lower UVA dose triggering the urticaria is the MUD. | 12 weeks after the end of treatment | 
| Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity | Proportion of patients achieving 50% improvement in solar urticaria intensity, compared to baseline, assessed by Visual Analogic Scale (scale extending from 0 to 10) | 4 and 12 weeks after the end of treatment | 
| Proportion of Patients Achieving Clinical Remission of Solar Urticaria | Proportion of patients showing no or less clinical signs or solar urticaria compared to baseline, under experimental conditions | 4 and 12 weeks after the end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omalizumab, Efficacy, Safety