Last updated on June 2019

A Study of the Efficacy and Safety of Risankizumab in Subjects With Crohn's Disease Who Responded to Induction Treatment in M16-006 or M15-991; or Completed M15-989

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 subjects 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 subjects 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 subjects who completed Sub-study 1, Sub-study 2 or the Phase 2, open-label extension study M15-989.

Clinical Study Identifier: NCT03105102

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SIH Research, LLC /ID# 163083

Kissimmee, FL United States
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Alliance Medical Research /ID# 163837

Lighthouse Point, FL United States
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Advanced Research Institute /ID# 161966

New Port Richey, FL United States
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IMIC Inc. /ID# 154942

Palmetto Bay, FL United States
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Delricht Research /ID# 206644

New Orleans, LA United States
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NY Scientific /ID# 158294

Brooklyn, NY United States
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Univ NC Chapel Hill /ID# 154833

Chapel Hill, NC United States
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Tri-State Endoscopy /ID# 154927

Cincinnati, OH United States
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Hightower Clinical /ID# 211993

Oklahoma City, OK United States
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Gastro One /ID# 154726

Germantown, TN United States
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Sagact Pllc /Id# 168773

San Antonio, TX United States
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Cemic /Id# 168078

Buenos Aires, Argentina
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Hospital Britanico de Buenos /ID# 168077

Ciudad Autonomade Buenos Aires, Argentina
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Hopital Nord /ID# 162562

Saint Priest En Jarez, France
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Dr Eduan Deetlefs /ID# 158116

Cape Town,Milnerton, South Africa
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Royal Victoria Infirmary, Newc /ID# 163708

Newcastle Upon Tyne, United Kingdom
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Recruitment Status: Open

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