Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-05 @ 12:06 AM
Study NCT ID:
NCT01635127
Status:
UNKNOWN
Last Update Posted:
2016-09-27
First Post:
2012-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Canakinumab to Treat Urticaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}], 'ancestors': [{'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'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': 'C541220', 'term': 'canakinumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-26', 'studyFirstSubmitDate': '2012-07-03', 'studyFirstSubmitQcDate': '2012-07-03', 'lastUpdatePostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete clinical remission', 'timeFrame': '4 weeks', 'description': 'Improvement of urticaria within 4 weeks, objective measurements daily wheal score and UAS7'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Idiopathic Urticaria']}, 'referencesModule': {'references': [{'pmid': '32827729', 'type': 'DERIVED', 'citation': 'Maul JT, Distler M, Kolios A, Maul LV, Guillet C, Graf N, Imhof L, Lang C, Navarini AA, Schmid-Grendelmeier P. Canakinumab Lacks Efficacy in Treating Adult Patients with Moderate to Severe Chronic Spontaneous Urticaria in a Phase II Randomized Double-Blind Placebo-Controlled Single-Center Study. J Allergy Clin Immunol Pract. 2021 Jan;9(1):463-468.e3. doi: 10.1016/j.jaip.2020.07.058. Epub 2020 Aug 20.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation whether canakinumab leads to improvement of urticaria', 'detailedDescription': 'Single center prospective placebo-controlled cross-over phase II study.\n\n* To assess if canakinumab can induce clinical improvement and/or complete clinical remission of chronic idiopathic urticaria at week 4 as compared to placebo\n* To compare canakinumab and placebo treated patients in the percentage who achieve complete clinical remission at week 1, 2, 4, and 8.\n* To compare the percentage with clinical improvement as measured by UAS7 score at week 1, 2, 4, and 8 in canakinumab and placebo treated patients\n* To compare the percentage of canakinumab and placebo treated patients with 75% and 100% improvement of their baseline (Run-in-period) UAS7 score at week 1,2,4,and 8\n* To compare the daily wheal score for Days 1 to 7 in canakinumab and placebo treated patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n* Diagnosis of chronic idiopathic urticaria for more than 6 weeks as confirmed by clinical and, if necessary, histological examination\n* CIU of moderate to severe severity defined by all of the following\n\n * Physician severity score of 2 or 3 (on a scale from 0 - 3)\n * Run-in period of the diary-based UAS7 score of \\> 21 (on a scale from 0 - 42)\n * Symptomatic despite use of non-sedating antihistamine with or without concomitant leukotriene antagonist/corticosteroids\n* Use of maintenance non-sedating antihistamine at a stable dose for at least 1 week prior to entering run-in period\n* Maintenance corticosteroids at a dose of \\<20 mg/day or \\<0.4 mg/kg stable for at least the week prior to study entry for treatment of the patient's CIU will be allowed.\n* Age: \\> 18 years.\n* Signed informed consent\n* Negative or unreactive QuantiFERON test (QFT-TB G In-Tube) or history of adequate treatment of active or latent tuberculosis.\n\nExclusion criteria:\n\n* Age \\< 18 or \\> 70 years\n* History of cancer except for treated basal cell carcinoma of the skin\n* With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection, active or untreated latent tuberculosis.\n* Patients currently treated with systemic immunosuppressive agents or following treatments in the specified period before the baseline visit:\n\n * corticosteroids =20 mg/day or \\>0.4 mg/kg for 1 week prior to study entry;\n * leukotriene antagonists for 1 week prior to study entry\n * colchicine, dapsone or mycophenolate mofetil for 3 weeks;\n * etanercept, leflunomide (documentation of a completion of a full cholestyramine elimination treatment after most recent leflunomide use will be required), thalidomide or ciclosporin for 4 weeks;\n * adalimumab or intravenous immunoglobulin for 8 weeks;\n * infliximab, 6-mercaptopurine, azathioprine, cyclophosphamide or chlorambucil for 12 weeks\n* Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose\n* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,\n* Pregnant or lactating women, patients (men or women) planning a pregnancy during the duration of the study, lack of safe contraception.\n* Safe contraception is defined as follows:\n* Double-barrier contraception such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices together with condom use.\n* Both men and women must use safe contraception (double-barrier as defined above) during the duration of the study and until 6 months after the study.\n* Please note that female subjects who are surgically sterilized/hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential.\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject.\n* Participation in another study with investigational drug within the 30 days preceding and during the present study.\n* Previous enrolment into the current study.\n* Enrolment of the investigator, his/her family members, employees and other dependent persons."}, 'identificationModule': {'nctId': 'NCT01635127', 'acronym': 'URTICANA', 'briefTitle': 'Efficacy Study of Canakinumab to Treat Urticaria', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'A Phase II Randomized Double-Blind Placebo Controlled Single Center Study of Canakinumab Treatment of Adult Patients With Moderate to Severe Chronic Idiopathic Urticaria', 'orgStudyIdInfo': {'id': 'USZ-DER-AAN-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Canakinumab', 'description': 'Monoclonal antibody inhibiting interleukin 1 beta', 'interventionNames': ['Drug: Canakinumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Constituent, inactive', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Canakinumab', 'type': 'DRUG', 'otherNames': ['Ilaris'], 'description': '150mg s.c.', 'armGroupLabels': ['Canakinumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Constituent of canakinumab', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Division of Dermatology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Antonios Kolios, MD', 'role': 'CONTACT', 'email': 'antonios.kolios@usz.ch', 'phone': '+41 (0)44 255 11 11'}, {'name': 'Alexander Navarini, MD PhD', 'role': 'CONTACT', 'email': 'alexander.navarini@usz.ch'}], 'overallOfficials': [{'name': 'Peter Schmid-Grendelmeier, Prof MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Division of Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}