Status:
COMPLETED
Omalizumab in Severe and Refractory Solar Urticaria
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Collaborating Sponsors:
Novartis
Conditions:
Solar Urticaria
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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, lead...
Detailed 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.
Eligibility Criteria
Inclusion
- 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
- Contra indication to omalizumab
- Previous treatment with omalizumab
Key Trial Info
Start Date :
September 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02262130
Start Date
September 30 2014
End Date
September 29 2015
Last Update
October 12 2018
Active Locations (13)
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1
CHU de Angers
Angers, France
2
Dermatology department, Centre Hospitalier Régional Universitaire
Besançon, France
3
CHU de Caen
Caen, France
4
CHU de Dijon
Dijon, France