Omalizumab in Severe and Refractory Solar Urticaria

Solar Urticaria Clinical Trial

— XOLUS  

Official title:

Phase 2 Multicentric Study Evaluating the Efficacy of Omalizumab in Idiopathic Severe and Refractory Solar Urticaria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262130
• Other study ID #: P/2013/209
• Status: Completed
• Phase: Phase 2
• Start date: September 30, 2014
• Est. completion date: September 29, 2015

Study information

• Verified date: October 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 29, 2015
• Est. primary completion date: September 29, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solar Urticaria
• Urticaria

Intervention

Drug:
• Omalizumab

Locations

Country	Name	City	State
France	CHU de Angers	Angers
France	Dermatology department, Centre Hospitalier Régional Universitaire	Besançon
France	CHU de Caen	Caen
France	CHU de Dijon	Dijon
France	CHU de Grenoble	Grenoble
France	CHRU de Lille	Lille
France	CHU de Limoges	Limoges
France	CHU de Montpellier	Montpellier
France	CHU de Nancy	Nancy
France	Dermatology department, Hôpital Saint-Louis	Paris
France	CHU de Reims	Reims
France	CHU de Rennes	Rennes
France	CHU de Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Novartis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)	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.	4 weeks after the end of treatment
Secondary	Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6	Proportion of patients for whom the treatment with omalizumab allowed achieving DLQI < 6.; The index extends from 0 to 30: 0 - 1 = no effect at all on patient's life / 2 - 5 = small effect on patient's life / 6 - 10 = moderate effect on patient's life / 11 - 20 = very large effect on patient's life / 21 - 30 = extremely large effect on patient's life	4 and 12 weeks after the end of treatment
Secondary	Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)	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.	12 weeks after the end of treatment
Secondary	Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity	Proportion of patients achieving 50% improvement in solar urticaria intensity, compared to baseline, assessed by Visual Analogic Scale (scale extending from 0 to 10)	4 and 12 weeks after the end of treatment
Secondary	Proportion of Patients Achieving Clinical Remission of Solar Urticaria	Proportion of patients showing no or less clinical signs or solar urticaria compared to baseline, under experimental conditions	4 and 12 weeks after the end of treatment