Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria

Study Overview
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Brief Summary
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Solar urticaria is a rare but debilitating disease that can severely impact the quality of life, restricting outdoor activities.Treatment, based on sun protection and anti-histaminic drugs, is efficacious in 2 patients out of 3. In refractory patients, photodesensitization or immunosuppressive treatments such as cyclosporin A can be proposed. As in idiopathic urticaria, intravenous immunoglobulins (IVIG)have been shown, in a retrospective study of 7 patients, to dramatically improve 71% of patients. In an open-label prospective multicenter study, we aim to demonstrate the efficacy of a single IVIG administration (2g/kg) in 10 patients affected with severe and refractory solar urticaria.

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

Conditions
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Solar Urticaria

Intervention / Treatment
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* Drug: Intravenous immunoglobulins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: social insurance signed informed consent solar urticaria (SU) confirmed with photoexplorations SU involving the face or generalized to the whole body or accompanied with bronchospasm or triggered by artificial light or per annual SU SU with altered quality of life SU resistant to photoprotection SU resistant to the association of two different antihistaminics during 3 months Exclusion Criteria: Pregnancy Heat triggered urticaria Contra-indications to IVIG

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Intravenous immunoglobulins<br>Intravenous immunoglobulins | Drug: Intravenous immunoglobulins<br>* Single administration of 2 g/kg intravenous immunoglobulins over 2 days<br>* Other names: CLAIRYG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients obtaining 1 month after treatment a 10 fold increase of pretherapeutic minimal urticarial dose |  | 1 month | 
| Percentage of patients obtaining 1 month after treatment an improvement of quality of life |  | 1 month | 
| Percentage of patients obtaining after 1 month of treatment a complete clinical response |  | 1 month | 
| Percentage of patients obtaining 1 month after treatment a 50% and a 75% improvement of disease severity |  | 1 month | 
| Percentage of patients obtaining 6 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose |  | 6 months | 
| Percentage of patients obtaining 12 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose |  | 12 months | 
| Percentage of patients obtaining 3 months after treatment an improvement of quality of life |  | 3 months | 
| Percentage of patients obtaining 6 months after treatment an improvement of quality of life |  | 6 months | 
| Percentage of patients obtaining 12 months after treatment an improvement of quality of life |  | 12 months | 
| Percentage of patients obtaining after 3 months of treatment a complete clinical response |  | 3 months | 
| Percentage of patients obtaining after 6 months of treatment a complete clinical response |  | 6 months | 
| Percentage of patients obtaining after 12 months of treatment a complete clinical response |  | 12 months | 
| Percentage of patients obtaining 3 months after treatment a 50% and a 75% improvement of disease severity |  | 3 months | 
| Percentage of patients obtaining 6 months after treatment a 50% and a 75% improvement of disease severity |  | 6 months | 
| Percentage of patients obtaining 12 months after treatment a 50% and a 75% improvement of disease severity |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravenous immunoglobulins, Solar urticaria, Minimal urticaria dose, Quality of life, Safety