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Omalizumab in Severe and Refractory Solar Urticaria (XOLUS)

Primary Purpose

Solar Urticaria

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Omalizumab
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solar Urticaria focused on measuring Omalizumab, Efficacy, Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Omalizumab

Arm Description

Omalizumab 300 mg W0, W4 and W8

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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)
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

Full Information

First Posted
October 7, 2014
Last Updated
October 8, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT02262130
Brief Title
Omalizumab in Severe and Refractory Solar Urticaria
Acronym
XOLUS
Official Title
Phase 2 Multicentric Study Evaluating the Efficacy of Omalizumab in Idiopathic Severe and Refractory Solar Urticaria
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 30, 2014 (Actual)
Primary Completion Date
September 29, 2015 (Actual)
Study Completion Date
September 29, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
Collaborators
Novartis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solar Urticaria
Keywords
Omalizumab, Efficacy, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Omalizumab
Arm Type
Experimental
Arm Description
Omalizumab 300 mg W0, W4 and W8
Intervention Type
Drug
Intervention Name(s)
Omalizumab
Primary Outcome Measure Information:
Title
Proportion of Patients With Remission of Solar Urticaria Under Experimental Conditions (Phototesting)
Description
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.
Time Frame
4 weeks after the end of treatment
Secondary Outcome Measure Information:
Title
Proportion of Patients for Whom the Treatment Allowed Achieving Dermatology Life Quality Index< 6
Description
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
Time Frame
4 and 12 weeks after the end of treatment
Title
Proportion of Patients With Solar Urticaria Remission Under Experimental Conditions (Phototesting)
Description
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.
Time Frame
12 weeks after the end of treatment
Title
Proportion of Patients Achieving 50% Improvement in Solar Urticaria Intensity
Description
Proportion of patients achieving 50% improvement in solar urticaria intensity, compared to baseline, assessed by Visual Analogic Scale (scale extending from 0 to 10)
Time Frame
4 and 12 weeks after the end of treatment
Title
Proportion of Patients Achieving Clinical Remission of Solar Urticaria
Description
Proportion of patients showing no or less clinical signs or solar urticaria compared to baseline, under experimental conditions
Time Frame
4 and 12 weeks after the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuelle Viguier, MD, PhD
Organizational Affiliation
Assistance Publique-Hôpitaux de Paris, Université Paris 7
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
François AUBIN, Prof.
Organizational Affiliation
Centre hospitalier régional universitaire de Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Angers
City
Angers
Country
France
Facility Name
Dermatology department, Centre Hospitalier Régional Universitaire
City
Besançon
Country
France
Facility Name
CHU de Caen
City
Caen
Country
France
Facility Name
CHU de Dijon
City
Dijon
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Facility Name
CHRU de Lille
City
Lille
Country
France
Facility Name
CHU de Limoges
City
Limoges
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Facility Name
CHU de Nancy
City
Nancy
Country
France
Facility Name
Dermatology department, Hôpital Saint-Louis
City
Paris
Country
France
Facility Name
CHU de Reims
City
Reims
Country
France
Facility Name
CHU de Rennes
City
Rennes
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

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Omalizumab in Severe and Refractory Solar Urticaria

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