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Omalizumab in Severe and Refractory Solar Urticaria (XOLUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02262130
Recruitment Status : Completed
First Posted : October 10, 2014
Results First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solar Urticaria Drug: Omalizumab Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Multicentric Study Evaluating the Efficacy of Omalizumab in Idiopathic Severe and Refractory Solar Urticaria
Actual Study Start Date : September 30, 2014
Actual Primary Completion Date : September 29, 2015
Actual Study Completion Date : September 29, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives
Drug Information available for: Omalizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Omalizumab
Omalizumab 300 mg W0, W4 and W8
 Drug: Omalizumab


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262130


Locations
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France
CHU de Angers
Angers, France
Dermatology department, Centre Hospitalier Régional Universitaire
Besançon, France
CHU de Caen
Caen, France
CHU de Dijon
Dijon, France
CHU de Grenoble
Grenoble, France
CHRU de Lille
Lille, France
CHU de Limoges
Limoges, France
CHU de Montpellier
Montpellier, France
CHU de Nancy
Nancy, France
Dermatology department, Hôpital Saint-Louis
Paris, France
CHU de Reims
Reims, France
CHU de Rennes
Rennes, France
CHU de Toulouse
Toulouse, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Novartis
Investigators
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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
More Information
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02262130    
Other Study ID Numbers: P/2013/209
First Posted: October 10, 2014    Key Record Dates
Results First Posted: October 12, 2018
Last Update Posted: October 12, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Omalizumab
Efficacy
Safety
Additional relevant MeSH terms:
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Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
 Immune System Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents