Overview

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