Last updated on September 2020

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease


Brief description of study

The study consists of 3 sub-studies, as follows:

  • Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction treatment in Study M16-006 or Study M15-991
  • Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991;
  • Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2 or the Phase 2, open-label extension study M15-989, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic.

Clinical Study Identifier: NCT03105102

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Long Island Clinical Research /ID# 154829

Great Neck, NY United States
4.85miles
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Digestive Dis Care/Excel Med /ID# 211777

New Hyde Park, NY United States
5.91miles
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North Shore University Hospital /ID# 168738

New Hyde Park, NY United States
5.91miles
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Icahn School of Med Mt. Sinai /ID# 165612

New York, NY United States
8.68miles
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The Mount Sinai Hospital /ID# 165612

New York, NY United States
8.68miles
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Weill Cornell Medicine /ID# 165878

New York, NY United States
9.03miles
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Concorde Medical Group PLLC /ID# 211537

New York, NY United States
9.59miles
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NYU Langone Medical Center /ID# 160169

New York, NY United States
9.71miles
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Recruitment Status: Open


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