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
  • Crohn's Disease (CD)
  • Study Drug
  • Risankizumab 600 mg IV
  • Risankizumab 180 mg SC
  • 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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