Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-03-02 @ 3:44 PM
Study NCT ID:
NCT01764594
Status:
COMPLETED
Last Update Posted:
2015-07-16
First Post:
2013-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607972', 'term': 'dapirolizumab pegol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-14', 'studyFirstSubmitDate': '2013-01-02', 'studyFirstSubmitQcDate': '2013-01-07', 'lastUpdatePostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study', 'timeFrame': '0 - 28 Weeks'}, {'measure': 'Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study', 'timeFrame': '0 - 28 Weeks'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': '0 - 28 Weeks'}, {'measure': 'Predose plasma concentration (Ctrough)', 'timeFrame': '0 - 28 Weeks'}, {'measure': 'Area under the concentration-time curve over the dosing interval (AUCĪ)', 'timeFrame': '0 - 28 Weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lupus', 'SLE'], 'conditions': ['Immune System Diseases', 'Autoimmune Diseases', 'Lupus Erythematosus, Systemic', 'Skin and Connective Tissue Diseases', 'Connective Tissue Disease']}, 'referencesModule': {'references': [{'pmid': '28780512', 'type': 'DERIVED', 'citation': 'Chamberlain C, Colman PJ, Ranger AM, Burkly LC, Johnston GI, Otoul C, Stach C, Zamacona M, Dorner T, Urowitz M, Hiepe F. Repeated administration of dapirolizumab pegol in a randomised phase I study is well tolerated and accompanied by improvements in several composite measures of systemic lupus erythematosus disease activity and changes in whole blood transcriptomic profiles. Ann Rheum Dis. 2017 Nov;76(11):1837-1844. doi: 10.1136/annrheumdis-2017-211388. Epub 2017 Aug 5.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Systemic Lupus Erythematosus (SLE)\n\nExclusion Criteria:\n\n* Severe neuropsychiatric or severe renal Systemic Lupus Erythematosus (SLE)\n* History of chronic, recurrent, or recent severe infection\n* Significant hematologic abnormalities\n* History of cancer, heart failure, renal disease, liver disease or other serious illness'}, 'identificationModule': {'nctId': 'NCT01764594', 'briefTitle': 'Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Multicenter, Investigator- and Subject-Blind, Randomized, Placebo-Controlled, Parallel-Group, Repeat-Dose Study to Evaluate the Effect of CDP7657 in Subjects With Active Systemic Lupus Erythematosus', 'orgStudyIdInfo': {'id': 'SL0014'}, 'secondaryIdInfos': [{'id': '2012-000631-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CDP7657', 'description': 'CDP7657 100 mg/ ml solution\n\n30 mg/ kg initial dose\n\n15 mg/ kg every other week\n\n10 weeks', 'interventionNames': ['Biological: CDP7657']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'CDP7657', 'type': 'BIOLOGICAL', 'description': 'CDP7657 100 mg/ ml solution\n\n30 mg/ kg initial dose\n\n15 mg/ kg every other week\n\n10 weeks', 'armGroupLabels': ['CDP7657']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo comparator', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brussels', 'country': 'Belgium', 'facility': '102', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': '101', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Plovidv', 'country': 'Bulgaria', 'facility': '203'}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': '201', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Sofia', 'country': 'Bulgaria', 'facility': '202', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Berlin', 'country': 'Germany', 'facility': '301', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Erlangen', 'country': 'Germany', 'facility': '303', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': '305', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Greifswald', 'country': 'Germany', 'facility': '306', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'city': 'Hanover', 'country': 'Germany', 'facility': '304', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Kiel', 'country': 'Germany', 'facility': '302', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Krakow', 'country': 'Poland', 'facility': '501', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Wroclaw', 'country': 'Poland', 'facility': '503', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': '601', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': '602', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Moscow', 'country': 'Russia', 'facility': '701', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Yaroslavl', 'country': 'Russia', 'facility': '702', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'city': 'Hospitalet Del Llobregat', 'country': 'Spain', 'facility': '401'}, {'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': '402', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Seville', 'country': 'Spain', 'facility': '404', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Seville', 'country': 'Spain', 'facility': '405', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biogen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}