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A Phase II, Multicenter, Randomized, Double-blind, Multiple Dose, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of BI 655066/ABBV-066 (Risankizumab), an IL-23 p19 Antagonist Monoclonal Antibody, in Patients With Moderately to Severely Active Crohn's Disease, Who Are naive to, or Were Previously Treated With Anti-TNF Therapy

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Trial Profile

A Phase II, Multicenter, Randomized, Double-blind, Multiple Dose, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of BI 655066/ABBV-066 (Risankizumab), an IL-23 p19 Antagonist Monoclonal Antibody, in Patients With Moderately to Severely Active Crohn's Disease, Who Are naive to, or Were Previously Treated With Anti-TNF Therapy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Risankizumab (Primary) ; Risankizumab (Primary)
  • Indications Crohn's disease
  • Focus Biomarker; Proof of concept; Therapeutic Use
  • Sponsors AbbVie; Boehringer Ingelheim Pharma KG; Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 20 Aug 2018 Results (n=272) of pooled analysis from phase I and II studies (NCT01577550, NCT02054481 and NCT02031276) published in the Clinical Pharmacokinetics
    • 01 Nov 2017 Results presented at the 25th United European Gastroenterology Week
    • 09 May 2017 Results assesing the efficacy and safety of open-label subcutaneous risankizumab maintenance therapy (n=62) at week 52, presented at the Digestive Disease Week 2017.
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