Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-01-01 @ 10:41 AM
Study NCT ID:
NCT01451450
Status:
WITHDRAWN
Last Update Posted:
2012-07-23
First Post:
2011-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of 4 Doses of QGE031 in Patients 18-50 Years of Age With Peanut Allergy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Germany', 'Greece', 'Italy', 'Netherlands', 'Switzerland', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D021183', 'term': 'Peanut Hypersensitivity'}], 'ancestors': [{'id': 'D000074924', 'term': 'Nut and Peanut Hypersensitivity'}, {'id': 'D005512', 'term': 'Food Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000598891', 'term': 'ligelizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-20', 'studyFirstSubmitDate': '2011-10-10', 'studyFirstSubmitQcDate': '2011-10-12', 'lastUpdatePostDateStruct': {'date': '2012-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-13', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Peanut Allergy'], 'conditions': ['Peanut Allergy']}, 'descriptionModule': {'briefSummary': 'This study will assess the clinical potency of several exposure levels of QGE031 in decreasing the sensitivity against peanut allergen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Diagnosis of acute peanut allergy as manifested by urticaria, angioedema, gastro-intestinal or respiratory tract symptoms, with acute onset of symptoms after ingestion (up to 2 hours).\n* Positive peanut food challenge at baseline, i.e., have objective allergic events at a level of 300mg (not cumulative) or below of peanut protein but not to the placebo test.\n\nMain Exclusion Criteria:\n\n* Prior exposure to any monoclonal antibody treatment\n* Asthma patients on maintenance long acting beta-agonists\n* Use of systemic corticosteroids\n* Concomitant use of beta blockers, ACE inhibitors, tiotropium or ipratropium, antidepressants, oral beta-agonists\n* Use of immunosuppressants within 6 months of visit 1 Other protocol-defined inclusion/exclusion criteria may appy'}, 'identificationModule': {'nctId': 'NCT01451450', 'briefTitle': 'Efficacy and Safety of 4 Doses of QGE031 in Patients 18-50 Years of Age With Peanut Allergy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase II, Randomized, Double Blind, Placebo-controlled, Parallel Design, Dose Ranging, Multi-center Trial of Four Levels of Exposure of QGE031 s.c. for 16 Weeks in Subjects Aged 18-50 Years of Age With Peanut Allergy', 'orgStudyIdInfo': {'id': 'CQGE031A2208'}, 'secondaryIdInfos': [{'id': '2011-000631-92', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QGE031 A', 'interventionNames': ['Drug: QGE031']}, {'type': 'EXPERIMENTAL', 'label': 'QGE031 B', 'interventionNames': ['Drug: QGE031']}, {'type': 'EXPERIMENTAL', 'label': 'QGE031 C', 'interventionNames': ['Drug: QGE031']}, {'type': 'EXPERIMENTAL', 'label': 'QGE031 D', 'interventionNames': ['Drug: QGE031']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo A', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo B', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo C', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo D', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'QGE031', 'type': 'DRUG', 'description': 'QGE031 liquid for subcutaneous injection.', 'armGroupLabels': ['QGE031 A', 'QGE031 B', 'QGE031 C', 'QGE031 D']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo liquid for subcutaneous injection.', 'armGroupLabels': ['Placebo A', 'Placebo B', 'Placebo C', 'Placebo D']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}