Omalizumab in Severe and Refractory Solar Urticaria

Centre Hospitalier Universitaire de Besancon10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solar Urticaria

Interventions

OmalizumabDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

CHU de Angers

Angers, France

Dermatology department, Centre Hospitalier Régional Universitaire

Besançon, France

CHU de Caen

Caen, France

CHU de Dijon

Outcomes

Primary Outcomes

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.

Time frame: 4 weeks after the end of treatment

Secondary Outcomes

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

Time frame: 4 and 12 weeks after the end of treatment

Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)

Time frame: 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)

Time frame: 4 and 12 weeks after the end of treatment

Proportion of Patients Achieving Clinical Remission of Solar Urticaria

Data from ClinicalTrials.gov

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