Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus
NCT ID: NCT01764594
Last Updated: 2015-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2013-01-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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CDP7657
CDP7657 100 mg/ ml solution
30 mg/ kg initial dose
15 mg/ kg every other week
10 weeks
CDP7657
CDP7657 100 mg/ ml solution
30 mg/ kg initial dose
15 mg/ kg every other week
10 weeks
Placebo
Placebo
Placebo
Placebo comparator
Interventions
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CDP7657
CDP7657 100 mg/ ml solution
30 mg/ kg initial dose
15 mg/ kg every other week
10 weeks
Placebo
Placebo comparator
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of chronic, recurrent, or recent severe infection
* Significant hematologic abnormalities
* History of cancer, heart failure, renal disease, liver disease or other serious illness
18 Years
75 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493
Locations
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102
Brussels, , Belgium
101
Leuven, , Belgium
203
Plovidv, , Bulgaria
201
Sofia, , Bulgaria
202
Sofia, , Bulgaria
301
Berlin, , Germany
303
Erlangen, , Germany
305
Frankfurt, , Germany
306
Greifswald, , Germany
304
Hanover, , Germany
302
Kiel, , Germany
501
Krakow, , Poland
503
Wroclaw, , Poland
601
Bucharest, , Romania
602
Cluj-Napoca, , Romania
701
Moscow, , Russia
702
Yaroslavl, , Russia
401
Hospitalet Del Llobregat, , Spain
402
Santiago de Compostela, , Spain
404
Seville, , Spain
405
Seville, , Spain
Countries
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References
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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.
Other Identifiers
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2012-000631-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SL0014
Identifier Type: -
Identifier Source: org_study_id
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