Omalizumab in Severe and Refractory Solar Urticaria (XOLUS)

Centre Hospitalier Universitaire de Besancon

Status and phase

Completed

Phase 2

Conditions

Solar Urticaria

Treatments

Drug: Omalizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02262130

P/2013/209

Details and patient eligibility

About

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.

Full description

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.