Omalizumab in Severe and Refractory Solar Urticaria

• Status: Completed
• Trial end date: 2015-09-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborator: Novartis
• Treatments: Omalizumab

Criteria

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