Omalizumab in Severe and Refractory Solar Urticaria (XOLUS)

October 8, 2018 updated by: Centre Hospitalier Universitaire de Besancon

Phase 2 Multicentric Study Evaluating the Efficacy of Omalizumab in Idiopathic 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omalizumab
Omalizumab 300 mg W0, W4 and W8
Drug: Omalizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks after the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 and 12 weeks after the end of treatment
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.
12 weeks after the end of treatment
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 and 12 weeks after the end of treatment
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
4 and 12 weeks after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

Novartis

Investigators

  • Principal Investigator: Manuelle Viguier, MD, PhD, Assistance Publique-Hôpitaux de Paris, Université Paris 7
  • Principal Investigator: François AUBIN, Prof., Centre Hospitalier Régional Universitaire de Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2014

Primary Completion (Actual)

September 29, 2015

Study Completion (Actual)

September 29, 2015

Study Registration Dates

First Submitted

October 7, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 8, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2013/209

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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