Clinical trial NCT02262130: Omalizumab in Severe and Refractory Solar Urticaria
Official title: Phase 2 Multicentric Study Evaluating the Efficacy of Omalizumab in Idiopathic Severe and Refractory Solar Urticaria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solar Urticaria
Keywords: Omalizumab
Efficacy
Safety
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2014-10-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)
timeFrame: 4 weeks after the end of treatment
Secondary outcomes:
measure: Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6
timeFrame: 4 and 12 weeks after the end of treatment
measure: Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)
timeFrame: 12 weeks after the end of treatment
measure: Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity
timeFrame: 4 and 12 weeks after the end of treatment
measure: Proportion of Patients Achieving Clinical Remission of Solar Urticaria
timeFrame: 4 and 12 weeks after the end of treatment
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU de Angers
city: Besançon
country: France
facility: Dermatology department, Centre Hospitalier Régional Universitaire
city: Caen
country: France
facility: CHU de Caen
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lille
country: France
facility: CHRU de Lille
city: Limoges
country: France
facility: CHU de Limoges
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nancy
country: France
facility: CHU de Nancy
city: Paris
country: France
facility: Dermatology department, Hôpital Saint-Louis
city: Reims
country: France
facility: CHU de Reims
city: Rennes
country: France
facility: CHU de Rennes
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: Assistance Publique-Hôpitaux de Paris, Université Paris 7
name: Manuelle Viguier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre hospitalier régional universitaire de Besançon
name: François AUBIN, Prof.
role: PRINCIPAL_INVESTIGATOR
References: