Skip to main content
OpenTrials
Completed

NCT Number: NCT02262130

Omalizumab in Severe and Refractory Solar Urticaria

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Solar Urticaria Chronic Disease Chronic Inducible Urticaria Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Photosensitivity Disorders Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Urticaria, Solar

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU de Angers, Angers, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omalizumab

Drug

Primary outcomes

  1. 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

  1. Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6

    Time frame: 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

  2. Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)

    Time frame: 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.

  3. Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity

    Time frame: 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)

  4. Proportion of Patients Achieving Clinical Remission of Solar Urticaria

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • Novartis

Registry information

Official study title

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

Acronym: XOLUS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 10, 2014
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.