A Long Term Extension Trial of BI 655066/ABBV-066 (Risankizumab), in Patients With Moderately to Severely Active Crohn's Disease
Study Identifier
M15-989
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete
Results Available
Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English, Dutch, German, Korean, Polish, Spanish
Scientific Result Summary
Available Language(s): English
Study Details
Medical Condition
Study Drug
Phase
Phase 2
Sex
Female & Male
Age
18 - 75 Years
Protocol Summary
The primary objective of the study was to investigate long-term safety of risankizumab (BI 655066/ABBV-066) in participants with moderately to severely active Crohn's disease who showed a clinical response or remission on previous treatment with risankizumab in Study NCT02031276 (BI trial 1311.6/ AbbVie M15-993) and were now receiving long-term treatment. Additional objectives of this study were to further investigate long-term efficacy, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of risankizumab.
Study Locations
Location
Status
Location
MGG Group, Inc.Chevy Chase Clinical Research /ID# 155068
Chevy Chase, Maryland, United States, 20815
Status
Not applicable
Location
Clin Res Inst of Michigan, LLC /ID# 155066
Chesterfield, Michigan, United States, 48047
Status
Not applicable
Location
Cliniques Universitaires Saint Luc /ID# 154985
Woluwe-Saint-Lambert, Brussels Capital, Belgium, 1200
Status
Not applicable
Location
CHU de Liege /ID# 154988
Liège, Liege, Belgium, 4000
Status
Not applicable
Location
Imelda Ziekenhuis /ID# 154984
Bonheiden, Belgium, 2820
Status
Not applicable
Location
ULB Erasme /ID# 154987
Brussels, Belgium, 1070
Status
Not applicable
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