Phase 2 Multicentric Study Evaluating the Efficacy of Omalizumab in Idiopathic Severe and Refractory Solar Urticaria
Overview
- Phase
- Phase 2
- Intervention
- Omalizumab
- Conditions
- Solar Urticaria
- Sponsor
- Centre Hospitalier Universitaire de Besancon
- Enrollment
- 10
- Locations
- 13
- Primary Endpoint
- Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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, 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.
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.
Investigators
Eligibility 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
Arms & Interventions
Omalizumab
Omalizumab 300 mg W0, W4 and W8
Intervention: Omalizumab
Outcomes
Primary Outcomes
Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)
Time Frame: 4 weeks after the end of treatment
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.
Secondary Outcomes
- Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6(4 and 12 weeks after the end of treatment)
- Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)(12 weeks after the end of treatment)
- Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity(4 and 12 weeks after the end of treatment)
- Proportion of Patients Achieving Clinical Remission of Solar Urticaria(4 and 12 weeks after the end of treatment)