Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT01360658
Status:
COMPLETED
Last Update Posted:
2013-07-30
First Post:
2011-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092130', 'term': 'Urticaria, Solar'}], 'ancestors': [{'id': 'D010787', 'term': 'Photosensitivity Disorders'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000094482', 'term': 'Chronic Inducible Urticaria'}, {'id': 'D000080223', 'term': 'Chronic Urticaria'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-29', 'studyFirstSubmitDate': '2011-05-23', 'studyFirstSubmitQcDate': '2011-05-24', 'lastUpdatePostDateStruct': {'date': '2013-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients obtaining 1 month after treatment a 10 fold increase of pretherapeutic minimal urticarial dose', 'timeFrame': '1 month'}, {'measure': 'Percentage of patients obtaining 1 month after treatment an improvement of quality of life', 'timeFrame': '1 month'}, {'measure': 'Percentage of patients obtaining after 1 month of treatment a complete clinical response', 'timeFrame': '1 month'}, {'measure': 'Percentage of patients obtaining 1 month after treatment a 50% and a 75% improvement of disease severity', 'timeFrame': '1 month'}, {'measure': 'Percentage of patients obtaining 6 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose', 'timeFrame': '6 months'}, {'measure': 'Percentage of patients obtaining 12 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose', 'timeFrame': '12 months'}, {'measure': 'Percentage of patients obtaining 3 months after treatment an improvement of quality of life', 'timeFrame': '3 months'}, {'measure': 'Percentage of patients obtaining 6 months after treatment an improvement of quality of life', 'timeFrame': '6 months'}, {'measure': 'Percentage of patients obtaining 12 months after treatment an improvement of quality of life', 'timeFrame': '12 months'}, {'measure': 'Percentage of patients obtaining after 3 months of treatment a complete clinical response', 'timeFrame': '3 months'}, {'measure': 'Percentage of patients obtaining after 6 months of treatment a complete clinical response', 'timeFrame': '6 months'}, {'measure': 'Percentage of patients obtaining after 12 months of treatment a complete clinical response', 'timeFrame': '12 months'}, {'measure': 'Percentage of patients obtaining 3 months after treatment a 50% and a 75% improvement of disease severity', 'timeFrame': '3 months'}, {'measure': 'Percentage of patients obtaining 6 months after treatment a 50% and a 75% improvement of disease severity', 'timeFrame': '6 months'}, {'measure': 'Percentage of patients obtaining 12 months after treatment a 50% and a 75% improvement of disease severity', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intravenous immunoglobulins', 'Solar urticaria', 'Minimal urticaria dose', 'Quality of life', 'Safety'], 'conditions': ['Solar Urticaria']}, 'descriptionModule': {'briefSummary': 'Solar urticaria is a rare but debilitating disease that can severely impact the quality of life, restricting outdoor activities.Treatment, based on sun protection and anti-histaminic drugs, is efficacious in 2 patients out of 3. In refractory patients, photodesensitization or immunosuppressive treatments such as cyclosporin A can be proposed. As in idiopathic urticaria, intravenous immunoglobulins (IVIG)have been shown, in a retrospective study of 7 patients, to dramatically improve 71% of patients. In an open-label prospective multicenter study, we aim to demonstrate the efficacy of a single IVIG administration (2g/kg) in 10 patients affected with severe and refractory solar urticaria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* social insurance\n* signed informed consent\n* solar urticaria (SU) confirmed with photoexplorations\n* SU involving the face or generalized to the whole body or accompanied with bronchospasm or triggered by artificial light or per annual SU\n* SU with altered quality of life\n* SU resistant to photoprotection\n* SU resistant to the association of two different antihistaminics during 3 months\n\nExclusion Criteria:\n\n* Pregnancy\n* Heat triggered urticaria\n* Contra-indications to IVIG'}, 'identificationModule': {'nctId': 'NCT01360658', 'acronym': 'IGUS', 'briefTitle': 'Intravenous Immunoglobulins in Severe and Refractory Solar Urticaria', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Phase 2 Multicentric Study Evaluating the Efficacy of Polyvalent Intravenous Immunoglobulins in Idiopathic Severe and Refractory Solar Urticaria', 'orgStudyIdInfo': {'id': 'N/2010/57'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous immunoglobulins', 'description': 'Intravenous immunoglobulins', 'interventionNames': ['Drug: Intravenous immunoglobulins']}], 'interventions': [{'name': 'Intravenous immunoglobulins', 'type': 'DRUG', 'otherNames': ['CLAIRYG'], 'description': 'Single administration of 2 g/kg intravenous immunoglobulins over 2 days', 'armGroupLabels': ['Intravenous immunoglobulins']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'country': 'France', 'facility': 'Regional University Hospital', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Regional University Hospital', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'facility': 'University hospital', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Regional University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '54035', 'city': 'Nancy', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Saint louis Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '35033', 'city': 'Rennes', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'François Aubin, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Besançon'}, {'name': 'Manuelle Viguier, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint-Louis Hospital, Paris, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}, {'name': 'Saint-Louis Hospital, Paris, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}