Omalizumab in Severe and Refractory Solar Urticaria

Phase 2

Completed

• Conditions: Solar Urticaria
• Interventions: Drug: Omalizumab

• Registration Number: NCT02262130
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Study Timeline

• Study Start: 2014-09-30
• Study First Submitted: 2014-10-07
• Study First Submitted QC: 2014-10-09
• Study First Posted: 2014-10-10
• Primary Completion: 2015-09-29
• Study Completion: 2015-09-29
• Results First Submitted: 2017-03-24
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-08
• Last Update Submitted: 2018-10-08
• Results First Posted: 2018-10-12
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omalizumab	Omalizumab	Omalizumab 300 mg W0, W4 and W8

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)	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 Outcome Measures

Name	Time	Method
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 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
Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)	12 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.
Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity	4 and 12 weeks after the end of treatment	Proportion of patients achieving 50% improvement in solar urticaria intensity, compared to baseline, assessed by Visual Analogic Scale (scale extending from 0 to 10)
Proportion of Patients Achieving Clinical Remission of Solar Urticaria	4 and 12 weeks after the end of treatment	Proportion of patients showing no or less clinical signs or solar urticaria compared to baseline, under experimental conditions

Trial Locations

Locations (13)

CHRU de Lille; 🇫🇷 Lille, France

Dermatology department, Hôpital Saint-Louis; 🇫🇷 Paris, France

CHU de Grenoble; 🇫🇷 Grenoble, France

CHU de Montpellier; 🇫🇷 Montpellier, France

CHU de Angers; 🇫🇷 Angers, France

CHU de Dijon; 🇫🇷 Dijon, France

CHU de Rennes; 🇫🇷 Rennes, France

CHU de Limoges; 🇫🇷 Limoges, France

CHU de Nancy; 🇫🇷 Nancy, France

CHU de Caen; 🇫🇷 Caen, France

Dermatology department, Centre Hospitalier Régional Universitaire; 🇫🇷 Besançon, France

CHU de Reims; 🇫🇷 Reims, France

CHU de Toulouse; 🇫🇷 Toulouse, France