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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omalizumab | Experimental | Omalizumab 300 mg W0, W4 and W8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Refractory criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuelle Viguier, MD, PhD | Assistance Publique-Hôpitaux de Paris, Université Paris 7 | Principal Investigator |
| François AUBIN, Prof. | Centre Hospitalier Universitaire de Besancon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Angers | Angers | France | ||||
| Dermatology department, Centre Hospitalier Régional Universitaire |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omalizumab | Omalizumab 300 mg W0, W4 and W8 Omalizumab |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omalizumab | Omalizumab 300 mg W0, W4 and W8 Omalizumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 4 weeks after the end of treatment |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omalizumab | Omalizumab 300 mg W0, W4 and W8 Omalizumab |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | Patient treated from 12th November 2014 to 17th June 2015. A positive pregnancy test was performed in September 2015 with echographic confirmation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr Manuelle Viguier | CHU de Reims | 00333 26 78 43 43 | mviguier@chu-reims.fr |
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| ID | Term |
|---|---|
| D000092130 | Urticaria, Solar |
| ID | Term |
|---|---|
| D010787 | Photosensitivity Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000094482 | Chronic Inducible Urticaria |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| 4 and 12 weeks after the end of treatment |
| 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. | 12 weeks after the end of treatment |
| 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) | 4 and 12 weeks after the end of treatment |
| 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 | 4 and 12 weeks after the end of treatment |
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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 | 1 patient withdrawn between week 12 and week 20 (discontinuation) | Posted | Count of Participants | Participants | 4 and 12 weeks after the end of treatment |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 12 weeks after the end of treatment |
|
|
|
| Secondary | 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) | 1 patient withdrawn between week 12 and week 20 (discontinuation) | Posted | Count of Participants | Participants | 4 and 12 weeks after the end of treatment |
|
|
|
| Secondary | 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 | 1 patient withdrawn between week 12 and week 20 (discontinuation) | Posted | Count of Participants | Participants | 4 and 12 weeks after the end of treatment |
|
|
|
| 2 |
| 10 |
| 9 |
| 10 |
|
| Cholecystectomy | Hepatobiliary disorders | Gallbladder removal |
|
| Nausea | Gastrointestinal disorders |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Asthenia | General disorders |
|
| Injection site reaction | General disorders |
|
| Asthma | Respiratory, thoracic and mediastinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| Odynophagia | Gastrointestinal disorders |
|
| Lymphopenia | Blood and lymphatic system disorders |
|
| Influenza | Infections and infestations |
|
| Vertigo | Ear and labyrinth disorders |
|
| Myalgia | Musculoskeletal and connective tissue disorders |
|
| Zona | Infections and infestations |
|
| Paresthesia | Nervous system disorders |
|
| Hot flashes | Vascular disorders |
|
| Nasopharyngitis | Infections and infestations |
|
| Faintness | General disorders |
|
| Hypotension | Vascular disorders |
|
| Iron deficiency | Investigations |
|
| Solar urticaria relapse | Skin and subcutaneous tissue disorders |
|
| Urinary tract infection | Infections and infestations |
|
| Rhinitis | Infections and infestations |
|
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| D000080223 | Chronic Urticaria |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
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